This UL white paper reviews Brazil’s current regulatory framework for medical
devices, and the requirements for those entities seeking to manufacture, import or
sell medical devices in the country. It also discusses the registration and certification
process required of all device manufacturers, importers and distributors, and the
steps necessary to secure and maintain approval for medical devices. This white
paper includes information on requirements found in RDC 27/IN-3 and Resolution 350,
published by Brazilian regulatory authorities in June 2011.
overview of Anvisa Requirements, Medical device classification and grouping, cadostro registration pathway,resgistro pathway,INMETRO Certification, Summary of Anvisa Registration Process
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.
UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.
UL offers a full suite of services to support compliance with FDA's UDI Rule.
For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434
http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices
The Japanese market for medical devices reached $37.6 billion in 2016 and is expected to grow to $45 billion by 2020, making it the second largest market globally in terms of growth rate. It remains heavily reliant on imports, especially for sophisticated devices. The regulatory agencies overseeing the medical device market in Japan are the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labor and Welfare (MHLW). Devices are classified based on risk into four classes, with Class I having the lowest risk and Class IV the highest. Regulatory approval processes differ depending on the class, ranging from self-declaration for Class I devices to pre-market approval from MHLW for Class III and
The VISX CV SI-1 CustomVue Slit Illuminator is a diagnostic device intended to facilitate inspection of the anterior eye segment. It consists of a slit illuminator and charger unit. Non-clinical testing showed compliance with electrical safety standards and no new safety concerns. The FDA determined it to be substantially equivalent to legally marketed predicate devices.
The healthcare industry in the UAE is growing rapidly as the government aims to improve healthcare standards and establish Dubai as a regional medical tourism hub. All medical devices sold in the UAE must be registered with the Ministry of Health. The registration guidelines were developed to prevent unsafe devices while providing access to beneficial technologies, and were modeled after international standards from the EU and US. Registration requires an application including device details, manufacturing and quality certifications, clinical evidence, and post-market monitoring plans. The process aims to ensure medical devices meet safety and efficacy requirements before approval and sale in the UAE market.
Clinical investigations - Intended Normal condition of use Antonio Bartolozzi
Clinical investigations of medical devices shall be performed:
1) By a sufficient number of intended users in a clinical environment representative of how the device will normally be used by the target patient population.
2) In accordance with the clinical investigation plan and clinical evaluation plan.
3) Under conditions of intended normal use, which includes foreseeable errors and misuse during intended operation according to the manufacturer's instructions.
overview of Anvisa Requirements, Medical device classification and grouping, cadostro registration pathway,resgistro pathway,INMETRO Certification, Summary of Anvisa Registration Process
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.
UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.
UL offers a full suite of services to support compliance with FDA's UDI Rule.
For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434
http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices
The Japanese market for medical devices reached $37.6 billion in 2016 and is expected to grow to $45 billion by 2020, making it the second largest market globally in terms of growth rate. It remains heavily reliant on imports, especially for sophisticated devices. The regulatory agencies overseeing the medical device market in Japan are the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labor and Welfare (MHLW). Devices are classified based on risk into four classes, with Class I having the lowest risk and Class IV the highest. Regulatory approval processes differ depending on the class, ranging from self-declaration for Class I devices to pre-market approval from MHLW for Class III and
The VISX CV SI-1 CustomVue Slit Illuminator is a diagnostic device intended to facilitate inspection of the anterior eye segment. It consists of a slit illuminator and charger unit. Non-clinical testing showed compliance with electrical safety standards and no new safety concerns. The FDA determined it to be substantially equivalent to legally marketed predicate devices.
The healthcare industry in the UAE is growing rapidly as the government aims to improve healthcare standards and establish Dubai as a regional medical tourism hub. All medical devices sold in the UAE must be registered with the Ministry of Health. The registration guidelines were developed to prevent unsafe devices while providing access to beneficial technologies, and were modeled after international standards from the EU and US. Registration requires an application including device details, manufacturing and quality certifications, clinical evidence, and post-market monitoring plans. The process aims to ensure medical devices meet safety and efficacy requirements before approval and sale in the UAE market.
Clinical investigations - Intended Normal condition of use Antonio Bartolozzi
Clinical investigations of medical devices shall be performed:
1) By a sufficient number of intended users in a clinical environment representative of how the device will normally be used by the target patient population.
2) In accordance with the clinical investigation plan and clinical evaluation plan.
3) Under conditions of intended normal use, which includes foreseeable errors and misuse during intended operation according to the manufacturer's instructions.
Free webinar on Unique Device Identificationnykathlen
The document discusses planning and implementation of Unique Device Identification (UDI) requirements within the medical device industry. It outlines a six step process: 1) Developing a UDI compliance plan, 2) Understanding machine readable technology, 3) Managing change, 4) Conducting risk assessments, 5) Implementing UDI across the value chain, and 6) Identifying data sources for FDA reporting. It also provides an overview of compliance dates for UDI labeling and data submission requirements based on device class.
UDI: What & How within the overall Medical Device value chainnancykathlen
The document discusses planning and implementation of Unique Device Identification (UDI) for medical devices, which includes six main steps: 1) developing a UDI compliance plan, 2) understanding machine-readable technology, 3) change management, 4) risk assessment, 5) implementing the UDI plan across the value chain, and 6) identifying data sources for FDA reporting. It also provides UDI formatting requirements and compliance dates for different medical device classes established by the FDA.
Canada medical device approval chart - EMERGOEMERGO
1. To market medical devices in Canada, manufacturers must classify their device according to regulations, implement an ISO 13485 quality management system with additional Canadian requirements, and obtain ISO 13485 certification from an accredited registrar.
2. Manufacturers then prepare license applications, supporting documents, and pay fees, with process times ranging from 1-8 months depending on device class.
3. Licenses must be renewed annually by meeting regulatory requirements and paying fees to avoid revocation.
summary of indian medical device rule 2017Arshadib
This document outlines the key points of the Indian Medical Device Rules of 2017. It defines medical devices and explains why regulation is necessary. It describes the various authorities and bodies involved in enforcement and oversight. The rules cover the classification, manufacturing, import, labeling, clinical investigation, and sale of medical devices in India. Manufacturers must comply with quality management standards and obtain the necessary licenses from the Central or State Licensing Authorities depending on the class of device. Clinical investigations require approval and oversight from ethics committees. The rules aim to improve safety, quality and ensure medical devices meet appropriate standards.
Step-by-Step Approach of Unique Device Identification (UDI)VISAMED GmbH
This document outlines the step-by-step approach for implementing Unique Device Identification (UDI) as required by the FDA. It discusses the history and objectives of UDI, what constitutes a UDI, how UDI benefits patient safety and supply chain efficiency, and the challenges involved in assigning UDIs, modifying packaging and labels, submitting UDI data to the Global UDI Database, and ensuring ongoing compliance. A high-level task list is provided to guide planning and execution of a company's UDI implementation project.
Leveraging UDI Database Requirements to Drive Data GovernancePTC
Delivered at the event “UDIs and Traceability for Medical Devices 2014” in Munich, May 21 – 22, 2014, Europe's only UDI-dedicated event for the medical device industry – with keynotes from the FDA and European Commission– this slideshare presents a Solution Provider’s perspective on the impact of Master Data on the UDI submission to the FDA UDI data base. In detail, the presentation highlights the following subjects:
- A checklist for compliance – What to consider when selecting a solution for UDI data submission
- Data management as a lever for streamlined submissions – Current situation, challenges, and best practices for establishing data governance within an organization
- How PTC solutions support UDI and data governance – PTC’s UDI solution and the broader approach for central product data management
The document discusses the regulatory environment for medical imaging products in the United States, including an overview of the FDA's role in regulating these products to protect public health and ensure they are safe and effective. It covers topics such as device classification, clearance requirements, quality system regulations, and compliance.
Regulations on Medical Device Excise Tax Proposed; Opportunities for CommentPatton Boggs LLP
The IRS and Treasury Department released a proposed rulemaking addressing the 2.3% excise tax imposed on medical device sales. The proposal defines taxable devices, provides an exemption for retail purchases, and outlines how existing manufacturer tax rules apply. A public hearing will be held in May to discuss the proposal, which does not address all raised issues such as treatment of vertically integrated companies. Medical device companies should analyze which products are taxable and comment on the proposal.
Guidelines for import and manufacture of medical devicesluojn126
This document outlines guidelines for importing and manufacturing medical devices in India. It declares certain sterile devices like stents and implants to be considered drugs and regulated accordingly. It provides procedures for registering and obtaining import licenses for these medical devices. Manufacturers must apply to state licensing authorities and provide details about manufacturing facilities, processes, and product standards to be allowed to locally produce these devices. The guidelines aim to regulate and monitor the quality of imported and locally-made medical devices.
Australia medical device registration and approval process - EMERGOEMERGO
1. To register a medical device in Australia, manufacturers must first determine the device's classification using Australia's regulations and submit an application through an Australian sponsor.
2. The sponsor will submit the application along with supporting documents to the Therapeutic Goods Administration (TGA) for review and approval.
3. If approved, the TGA will provide an Australian Register of Therapeutic Goods (ARTG) listing number allowing marketing in Australia. Listings do not expire as long as annual fees are paid and the device is not changed.
Sponsor Information and Training day Session B2 - Medical Devices - Accurate ...TGA Australia
This document provides an overview of manufacturer evidence requirements for medical devices in Australia. It discusses what constitutes manufacturer evidence, the minimum conformity assessment procedures required based on device classification, and how to accurately submit new or varied manufacturer evidence applications via the TGA's electronic business services system. Common issues with manufacturer evidence submissions like incomplete certificates or multiple documents being attached are also outlined.
Ensuring Integrity for Medical Tissues and DevicesTerso Solutions
Strategies for Ensuring Integrity for Medical Tissues and Devices. RFID technologies offer near-real time safe and secure item-level visibility. A Terso Solutions white paper written by Joe Pleshek, CEO and President.
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
Brazil medical device registration and approval chart - EMERGOEMERGO
Brazil has a classification system for medical devices with four classes - I, II, III, and IV. Class I and II devices require a simplified registration called a Cadastro, while Class III and IV devices require a more rigorous registration called a Registro. To register a device, a company must appoint a Brazil Registration Holder to submit the application to ANVISA and obtain necessary approvals. Certain devices may also require certification from inspection agency INMETRO. The registration process can take 1-3 months for Classes I and II or 8-15 months for Classes III and IV, though Class III and IV can take over 4 years if additional inspections are required.
Homologation and importation of medical products in Brazil - ANVISAAdler Martins
The document discusses Brazil's regulations for health equipment established by ANVISA. It provides definitions of health equipment and medical equipment. It outlines the process for registering and enrolling health equipment, including required documents, classification of equipment based on risk level, and import requirements. Regularization of equipment involves electronic petitioning, examination by ANVISA, and publication. Classification is also described, dividing equipment into four risk-based classes.
Medical Device Development Firm Glossary of terms and abbreviations.pdfAlexander Sprauve
Speck Design is a top medical device design company and engineering company. We offer end-to-end design services to develop medical products and have extensive experience researching, prototyping, designing, and bringing new medical devices to market. We also have expertise in reimagining existing medical devices for new or improved usage.
Our teams work to offer medical device design and development services, including industrial design, mechanical and electrical engineering, and setting up, running, and maintaining medical quality systems. Our approach is always human-centric, applying our human-centered design-thinking to the process to come up with creative, empathetic solutions in medical device design, product engineering, regulatory compliance, user research, and more. Throughout the last 20+ years, we have done design, engineering, and development across a vast set of medical devices and categories, including:
- Drug delivery devices
- Handheld surgical devices
- Patient monitoring devices
- Diagnostic medical devices
- Digital interface design for medical devices
- Medical device user research
- Home health care devices
As a top medical device design firm our work also includes life sciences projects such as product definition, technology roadmap discovery, future concept development, interface design, user research design, usability testing, engineering development and verification, design for CLIA certification, proof of concept prototyping, beta prototyping, ISO 13485 certified, FDA compliance, and intellectual property support.
Learn more about us here: https://www.speckdesign.com/markets/medical-device-design-company
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
Procedure for getting the manufacturing license of notified IVDs Products in ...Mayank Saini
1) The document outlines the procedure for obtaining a manufacturing license for notified in vitro diagnostic (IVD) products in India. It involves submitting an application with documents to the state and central drug authorities, who may request additional information.
2) If approved, joint inspections are conducted by state and central inspectors. If deficiencies are found, corrections must be made and reinspection may occur. Test batches are produced and evaluated.
3) Upon receiving positive evaluation reports and recommendations, the state authority can issue the manufacturing license, which is valid for 5 years. The process generally takes 6-9 months for notified IVDs. Non-notified IVD licenses have fewer requirements.
The MHRA has sent a letter to Peter Wei of Lotus Global Co Ltd confirming registration of Xiamen Jiqing Biomedical Technology Co., Ltd. as a manufacturer of in vitro diagnostic medical devices based on the information provided by Wei as their authorized representative. The letter notes that registration does not represent endorsement of the manufacturer's device classifications and that any changes to the registration information must be reported.
A brief introduction on medical device , how iit is regulated in india,its marketing authorization,classification, notified devices,import of device and registration process, fnctions of medical device department.
S.R.O.32(I)/2018.— In exercise of the powers conferred by section 23 of the Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012), the Drug Regulatory Authority of Pakistan, with the approval of the Federal Government, is pleased to make the following rules, namely
For more information:
Email: info@arqon.com
LinkedIn : ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs
Twitter: @ARQonSG
Medical device regulatory & registration in Asia/ASEAN: Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Myanmar, Nepal, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
-ARQon Service-
ARQon (Asia Regulatory & Quality Consultancy) is a regulatory consultancy firm for medical devices and drug companies. We assist our clients in areas of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World.
ASIA - Austria TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN - Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals
AMERICAS - Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE - Notified Bodies Approval
MIDDLE EAST - Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals
Free webinar on Unique Device Identificationnykathlen
The document discusses planning and implementation of Unique Device Identification (UDI) requirements within the medical device industry. It outlines a six step process: 1) Developing a UDI compliance plan, 2) Understanding machine readable technology, 3) Managing change, 4) Conducting risk assessments, 5) Implementing UDI across the value chain, and 6) Identifying data sources for FDA reporting. It also provides an overview of compliance dates for UDI labeling and data submission requirements based on device class.
UDI: What & How within the overall Medical Device value chainnancykathlen
The document discusses planning and implementation of Unique Device Identification (UDI) for medical devices, which includes six main steps: 1) developing a UDI compliance plan, 2) understanding machine-readable technology, 3) change management, 4) risk assessment, 5) implementing the UDI plan across the value chain, and 6) identifying data sources for FDA reporting. It also provides UDI formatting requirements and compliance dates for different medical device classes established by the FDA.
Canada medical device approval chart - EMERGOEMERGO
1. To market medical devices in Canada, manufacturers must classify their device according to regulations, implement an ISO 13485 quality management system with additional Canadian requirements, and obtain ISO 13485 certification from an accredited registrar.
2. Manufacturers then prepare license applications, supporting documents, and pay fees, with process times ranging from 1-8 months depending on device class.
3. Licenses must be renewed annually by meeting regulatory requirements and paying fees to avoid revocation.
summary of indian medical device rule 2017Arshadib
This document outlines the key points of the Indian Medical Device Rules of 2017. It defines medical devices and explains why regulation is necessary. It describes the various authorities and bodies involved in enforcement and oversight. The rules cover the classification, manufacturing, import, labeling, clinical investigation, and sale of medical devices in India. Manufacturers must comply with quality management standards and obtain the necessary licenses from the Central or State Licensing Authorities depending on the class of device. Clinical investigations require approval and oversight from ethics committees. The rules aim to improve safety, quality and ensure medical devices meet appropriate standards.
Step-by-Step Approach of Unique Device Identification (UDI)VISAMED GmbH
This document outlines the step-by-step approach for implementing Unique Device Identification (UDI) as required by the FDA. It discusses the history and objectives of UDI, what constitutes a UDI, how UDI benefits patient safety and supply chain efficiency, and the challenges involved in assigning UDIs, modifying packaging and labels, submitting UDI data to the Global UDI Database, and ensuring ongoing compliance. A high-level task list is provided to guide planning and execution of a company's UDI implementation project.
Leveraging UDI Database Requirements to Drive Data GovernancePTC
Delivered at the event “UDIs and Traceability for Medical Devices 2014” in Munich, May 21 – 22, 2014, Europe's only UDI-dedicated event for the medical device industry – with keynotes from the FDA and European Commission– this slideshare presents a Solution Provider’s perspective on the impact of Master Data on the UDI submission to the FDA UDI data base. In detail, the presentation highlights the following subjects:
- A checklist for compliance – What to consider when selecting a solution for UDI data submission
- Data management as a lever for streamlined submissions – Current situation, challenges, and best practices for establishing data governance within an organization
- How PTC solutions support UDI and data governance – PTC’s UDI solution and the broader approach for central product data management
The document discusses the regulatory environment for medical imaging products in the United States, including an overview of the FDA's role in regulating these products to protect public health and ensure they are safe and effective. It covers topics such as device classification, clearance requirements, quality system regulations, and compliance.
Regulations on Medical Device Excise Tax Proposed; Opportunities for CommentPatton Boggs LLP
The IRS and Treasury Department released a proposed rulemaking addressing the 2.3% excise tax imposed on medical device sales. The proposal defines taxable devices, provides an exemption for retail purchases, and outlines how existing manufacturer tax rules apply. A public hearing will be held in May to discuss the proposal, which does not address all raised issues such as treatment of vertically integrated companies. Medical device companies should analyze which products are taxable and comment on the proposal.
Guidelines for import and manufacture of medical devicesluojn126
This document outlines guidelines for importing and manufacturing medical devices in India. It declares certain sterile devices like stents and implants to be considered drugs and regulated accordingly. It provides procedures for registering and obtaining import licenses for these medical devices. Manufacturers must apply to state licensing authorities and provide details about manufacturing facilities, processes, and product standards to be allowed to locally produce these devices. The guidelines aim to regulate and monitor the quality of imported and locally-made medical devices.
Australia medical device registration and approval process - EMERGOEMERGO
1. To register a medical device in Australia, manufacturers must first determine the device's classification using Australia's regulations and submit an application through an Australian sponsor.
2. The sponsor will submit the application along with supporting documents to the Therapeutic Goods Administration (TGA) for review and approval.
3. If approved, the TGA will provide an Australian Register of Therapeutic Goods (ARTG) listing number allowing marketing in Australia. Listings do not expire as long as annual fees are paid and the device is not changed.
Sponsor Information and Training day Session B2 - Medical Devices - Accurate ...TGA Australia
This document provides an overview of manufacturer evidence requirements for medical devices in Australia. It discusses what constitutes manufacturer evidence, the minimum conformity assessment procedures required based on device classification, and how to accurately submit new or varied manufacturer evidence applications via the TGA's electronic business services system. Common issues with manufacturer evidence submissions like incomplete certificates or multiple documents being attached are also outlined.
Ensuring Integrity for Medical Tissues and DevicesTerso Solutions
Strategies for Ensuring Integrity for Medical Tissues and Devices. RFID technologies offer near-real time safe and secure item-level visibility. A Terso Solutions white paper written by Joe Pleshek, CEO and President.
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
Brazil medical device registration and approval chart - EMERGOEMERGO
Brazil has a classification system for medical devices with four classes - I, II, III, and IV. Class I and II devices require a simplified registration called a Cadastro, while Class III and IV devices require a more rigorous registration called a Registro. To register a device, a company must appoint a Brazil Registration Holder to submit the application to ANVISA and obtain necessary approvals. Certain devices may also require certification from inspection agency INMETRO. The registration process can take 1-3 months for Classes I and II or 8-15 months for Classes III and IV, though Class III and IV can take over 4 years if additional inspections are required.
Homologation and importation of medical products in Brazil - ANVISAAdler Martins
The document discusses Brazil's regulations for health equipment established by ANVISA. It provides definitions of health equipment and medical equipment. It outlines the process for registering and enrolling health equipment, including required documents, classification of equipment based on risk level, and import requirements. Regularization of equipment involves electronic petitioning, examination by ANVISA, and publication. Classification is also described, dividing equipment into four risk-based classes.
Medical Device Development Firm Glossary of terms and abbreviations.pdfAlexander Sprauve
Speck Design is a top medical device design company and engineering company. We offer end-to-end design services to develop medical products and have extensive experience researching, prototyping, designing, and bringing new medical devices to market. We also have expertise in reimagining existing medical devices for new or improved usage.
Our teams work to offer medical device design and development services, including industrial design, mechanical and electrical engineering, and setting up, running, and maintaining medical quality systems. Our approach is always human-centric, applying our human-centered design-thinking to the process to come up with creative, empathetic solutions in medical device design, product engineering, regulatory compliance, user research, and more. Throughout the last 20+ years, we have done design, engineering, and development across a vast set of medical devices and categories, including:
- Drug delivery devices
- Handheld surgical devices
- Patient monitoring devices
- Diagnostic medical devices
- Digital interface design for medical devices
- Medical device user research
- Home health care devices
As a top medical device design firm our work also includes life sciences projects such as product definition, technology roadmap discovery, future concept development, interface design, user research design, usability testing, engineering development and verification, design for CLIA certification, proof of concept prototyping, beta prototyping, ISO 13485 certified, FDA compliance, and intellectual property support.
Learn more about us here: https://www.speckdesign.com/markets/medical-device-design-company
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
Procedure for getting the manufacturing license of notified IVDs Products in ...Mayank Saini
1) The document outlines the procedure for obtaining a manufacturing license for notified in vitro diagnostic (IVD) products in India. It involves submitting an application with documents to the state and central drug authorities, who may request additional information.
2) If approved, joint inspections are conducted by state and central inspectors. If deficiencies are found, corrections must be made and reinspection may occur. Test batches are produced and evaluated.
3) Upon receiving positive evaluation reports and recommendations, the state authority can issue the manufacturing license, which is valid for 5 years. The process generally takes 6-9 months for notified IVDs. Non-notified IVD licenses have fewer requirements.
The MHRA has sent a letter to Peter Wei of Lotus Global Co Ltd confirming registration of Xiamen Jiqing Biomedical Technology Co., Ltd. as a manufacturer of in vitro diagnostic medical devices based on the information provided by Wei as their authorized representative. The letter notes that registration does not represent endorsement of the manufacturer's device classifications and that any changes to the registration information must be reported.
A brief introduction on medical device , how iit is regulated in india,its marketing authorization,classification, notified devices,import of device and registration process, fnctions of medical device department.
S.R.O.32(I)/2018.— In exercise of the powers conferred by section 23 of the Drug Regulatory Authority of Pakistan Act, 2012 (XXI of 2012), the Drug Regulatory Authority of Pakistan, with the approval of the Federal Government, is pleased to make the following rules, namely
For more information:
Email: info@arqon.com
LinkedIn : ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs
Twitter: @ARQonSG
Medical device regulatory & registration in Asia/ASEAN: Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Myanmar, Nepal, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
-ARQon Service-
ARQon (Asia Regulatory & Quality Consultancy) is a regulatory consultancy firm for medical devices and drug companies. We assist our clients in areas of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World.
ASIA - Austria TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN - Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals
AMERICAS - Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE - Notified Bodies Approval
MIDDLE EAST - Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals
medical device regulatory approval in USASuraj Pamadi
The document discusses the approval process for medical devices in the United States, including an overview of the classification system for medical devices (Class I, II, III), the requirements for each class (e.g. 510(k) notification or premarket approval), and the components required for a 510(k) premarket notification application to the FDA.
Overview and update of chinese medical device regulationCIRS China
In this presentation, it interprets the latest changes of China's medical device regulations which involves UDI, MAH, etc. and provide practical advices for overseas medical device enterprises to register and marketing in China under the new regulations.
Latest update Brazil Regulations By S. Jaime - Qserve Group (Qserve Conferen...qserveconference2013
The document discusses regulations for medical devices in Brazil, including the country's healthcare system and regulatory approval process. It outlines key steps such as classification, appointing a Brazilian registration holder, ANVISA GMP inspection, INMETRO certification, and ANVISA registration. The lengthy overall process and importance of understanding regulatory changes and working with a local partner are emphasized.
In the USA, medical devices are regulated by the Food and Drug Administration (FDA) with an aim to ensure safety and effectiveness of the devices. The Center for Devices and Radiological Health (CDRH) is an FDA component and looks after this program.
Japan medical device approval chart - Emergo EMERGO
The regulatory process for medical devices in Japan involves several key steps:
1) Classifying the device and appointing a Marketing Authorization Holder who will manage the registration process.
2) Implementing a Quality Management System that complies with relevant regulations.
3) Submitting an application to either the Pharmaceuticals and Medical Devices Agency or a Registered Certification Body, depending on the device class.
4) Undergoing an audit and receiving the appropriate certificate before marketing the device in Japan. Device registrations do not expire but must be renewed periodically.
AdvaMed 510(k) Submissions Workshop: How to Assemble A Bullet Proof 510(k) Su...Jon Lendrum
The document provides an overview of a workshop on assembling 510(k) submissions for the FDA. It discusses selecting a predicate device, organizing data, and preparing the actual 510(k) submission. Key points include understanding FDA Form 3654 (Standards Data Report), tips and best practices for 510(k) submissions, potential pitfalls, and common mistakes. The workshop objectives are to help attendees understand how to select a predicate device, collect and organize required data, and understand the overall 510(k) process.
For more information:
Email: info@arqon.com
LinkedIn : ARQon - Asia Regulatory and Quality Consultancy for Medical Device and Drugs
Twitter: @ARQonSG
Medical device regulatory & registration in Asia/ASEAN: Australia, Cambodia, China, Hong Kong, India, Indonesia, Japan, Malaysia, Myanmar, Nepal, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand, Vietnam
-ARQon Service-
ARQon (Asia Regulatory & Quality Consultancy) is a regulatory consultancy firm for medical devices and drug companies. We assist our clients in areas of regulatory and quality from product development to product registration to attain market approval in ASIA, ASEAN, EU, US, and the Rest of the World.
ASIA - Austria TGA, Taiwan FDA, New Zealand Medsafe, Japan MHLW, South Korea MFDS, Hong Kong MDCO, Pakistan DRA, Bangladesh DGDA, China FDA, India CDSCO Approvals
ASEAN - Singapore HSA, Cambodia DDF, MOH Indonesia, Malaysia MDA, Myanmar FDA, Philippines FDA, Thai FDA, Vietnam DMEC Approvals
AMERICAS - Brazil ANVISA, Health Canada, Colombia INVIMA, Costa Rica MOH, Mexico COFEPRIS, Peru DIGEMID, US FDA Approvals
EUROPE - Notified Bodies Approval
MIDDLE EAST - Egypt CAPA, Emirates MOH, Saudi Arabia FDA Approvals
Medical device and Patency
By MDD 93/42
Any devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―
diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
investigation, replacement or modification or support of the anatomy or of a physiological process;
supporting or sustaining life;
disinfection of medical devices; and
control of conception.
What is 510(k) ?
A 510(k) is a premarket submission made to FDA to demonstrate
that the device to be marketed is as safe and effective, that is,
substantially equivalent, to a legally marketed device
(section 513(i)(1)(a) FD&C act).
Medical Devices are notified as DRUGS under Drugs & Cosmetics Act. Section 3 (b) (iv) defines,
Medical Devices as “Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals”
India had no regulation for medical devices in place prior to 2005.
The import, manufacturing, distribution and Sale of medical devices in India are overseen by the Drugs and Cosmetics Act (1940) and Rules (1945)
Control and inspection are carried out by the CDSCO, state drug controllers and central/state laboratories.
This document discusses emerging FDA regulations and guidance related to medical device labeling during the COVID-19 pandemic. It provides details on recommended modifications to indications, functionality and labeling for several device types including remote ophthalmic devices, sterilizers, disinfectants, air purifiers, infusion pumps and face masks/respirators. The recommendations aim to expand device capabilities and environments of use while ensuring adequate instructions and safety information are provided in labeling.
Latin American Regulations - What you Don't KnowGreenlight Guru
Central and South America are emerging as hot new Medical Device markets. These two subject matter experts in the area break down everything from regulatory advantages and ethical dilemmas.
This presentation originally aired during the 2022 Global MedTech Regulatory Trends Virtual Summit.
Similar to Ul wp final_medical device approvals in brazil_v6 (20)
The document is UL's 2015 annual report which discusses how their science led advances in safety, security, and sustainability. Some key points:
- UL developed new safety standards for hoverboards and power banks to address risks from lithium batteries.
- They are addressing security challenges from IoT devices and helping merchants comply with new credit card technology requirements.
- Research was conducted on furniture emissions and 3D printing's impact on indoor air quality to advance sustainability.
Moving From Contactless to Wireless Technologies in Secure, Over-the-Air Tran...Underwriters Laboratories
This UL white paper discusses some of the many issues and challenges that must be addressed in the future deployment of wireless technology for the processing
of secure transactions. It begins with a discussion of the strengths and limitations of both contactless and wireless technologies. The white paper then reviews and assesses internal system risks, as well as external security concerns, for both technologies. The paper concludes with some thoughts on the future use of wireless technology in secure transactions, and how manufacturers can provide assurances to both system providers and users regarding the security of their private data.
This UL white paper provides an overview of the issues related to the presence of
pharmaceuticals and personal care products (PPCPs) in drinking water. The paper
discusses the possible effects of PPCPs on humans and on the environment and
summarizes recent research conducted by U.S. government agencies, UL and others on
PPCP concentrations found in public drinking water supplies and wastewater facilities.
The white paper also discusses available water treatment options for reducing PPCP concentrations and their relative effectiveness. The paper concludes with areas for
further research and a preview of possible future regulatory actions.
Applied Safety Science and Engineering Techniques (ASSETTM) merge hazard based safety engineering and safety science principles in an overall framework of a safety
management process to achieve, maintain and continuously improve safety. The ASSET process has been synthesized from current, industry-standard risk assessment and risk management guidelines, including recent International Organization for
Standardization (ISO), International Electrotechnical Commission (IEC) and American National Standards Institute (ANSI) publications.
Recent research regarding the modern residence fire is providing new insights into the advantages and limitations of current smoke alarm technologies. This white paper summarizes recent and current research conducted at UL on the changing nature of residential fires and the effectiveness of smoke alarm
technologies, and discusses the implications of this research for future standards development.
Technological advances and the increased allocation of electromagnetic spectrum for advanced communications have produced a wave of new electronic and digital devices
that communicate wirelessly. As a result, product manufacturers are increasingly abandoning wired communications interfaces in favor of wireless technologies that offer greater user mobility without compromising transmission speed and accuracy. But obtaining worldwide regulatory approval for products with integrated wireless modules is a complex process.
In the European Union (EU), compliance with the essential requirements of the EU’s directive on Radio & Telecommunications Terminal Equipment (also known as the R&TTE Directive) is required for all wireless transmitters, including wireless modules integrated into end host devices. Ensuring compliance with the Directive’s essential requirements is the legal obligation of any party that seeks to import or sell such devices in the EU. However, unlike regulations in the United States that require manufacturers to obtain approval either from the FCC or an FCC-approved telecommunications certification body (TCB), the EU approval process for wireless modules offer manufacturers some flexibility in their chosen method for demonstrating compliance, including the ability to self-declare compliance with the applicable harmonized standards.
This white paper from UL is discusses the key regulatory compliance and approval issues facing manufacturers and importers of host devices with integrated wireless modules. This paper provides information on the regulations regarding the sale of host devices with integrated wireless modules in the EU and guidance on how to efficiently navigate the Union’s regulatory approval process.
In January 2010, “IEC 62368-1 Ed 1.0: Audio/Video, Information and Communication Technology Equipment — Safety Requirements” was published as an international standard. The development was an outcome of almost eight years of planning, hard work and dedication by IEC TC108, the IEC technical committee responsible for standards for safety of electronic equipment within the field of audio/video, information technology, and communication technology.
This paper provides background on the new standard and looks ahead to the challenges and potential impact of its implementation.
The Life Cycle of Materials -- How New Phone Technology Affects the EnvironmentUnderwriters Laboratories
In just 30 years, mobile telephony has grown into a major global industry, with an estimated 5 billion users around the world (compared with a total world population of just under 7 billion people). While new subscriber growth has slowed somewhat in recent years, product turnover remains high, with over 1 billion new mobile phones shipped in 2009 alone. As a result of ever-advancing technology and product obsolescence in this market, it is estimated that some 300,000 mobile phones are sent to the trash every day in the United States alone.
This white paper examines the overall environmental impact of materials used in mobile phones, from the extraction of raw materials and component manufacturing required to produce the latest models, to the appropriate recovery and recycling of these products at end-of-life (EoL). While the scope of this paper is limited to mobile phones, similar materials are used in many other high technology products, including personal computers, portable entertainment players, and other types of information and communications devices. Energy consumption and radio frequency emissions at the product level are outside the scope of this paper.
This document discusses the increased anticipated use of flammable refrigerants in HVAC equipment and appliances in the US. It explores the safety challenges posed by flammable refrigerants like hydrocarbons, which present a risk of fire and explosion if there is a refrigerant leak. Stakeholders across the refrigerant, equipment, and regulatory sectors must work together to address gaps in standards and ensure the safe use of flammable refrigerants, through improved containment, ventilation, education, and restricting potential ignition sources near leaks. Widespread introduction of flammable refrigerants in the US began around 2008, driven by the phase-out of ozone-depleting and global warming alternatives.
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This document discusses the potential use of flammable refrigerants in HVAC equipment and appliances. It notes that while some flammable refrigerants have good environmental and performance properties, they also pose safety risks due to their flammability. The EPA regulates refrigerants through its SNAP program and has proposed rules to allow certain flammable refrigerants if equipment meets safety standards. Compliance with standards set by organizations like UL is also important for safety certification and installation. The document examines several relevant safety standards and calls for all stakeholders to fully consider risks and ensure safe use of flammable refrigerants in equipment.
The document discusses the dielectric voltage withstand test, which is used to evaluate the quality and strength of insulation in electrical devices. It explains that the test involves applying a high voltage to the insulation for one minute, and if the insulation holds without breakdown, the device passes. However, the document notes that simply exceeding a trip current threshold does not necessarily indicate a failure, as this could be due to the device's natural dielectric current rather than an insulation breakdown. The document provides background on insulation breakdown and recommends further investigation if a trip current is exceeded rather than automatically assuming a failure. It also discusses limitations of using the test, such as the potential for false failures, and alternatives like DC voltage testing.
The dielectric voltage withstand test subjects the insulation barrier of electrical devices to high voltage for one minute to test the quality and strength of insulation. However, the test is often misunderstood which can lead to incorrect results. Further testing may be needed if the initial test trips at a current above the threshold, as this does not always indicate dielectric breakdown. The objective of the test is to ensure insulation can prevent human contact with dangerous voltages and currents, but using a generic trip current setting may produce false failures. Proper investigation is needed if the test trips to understand the root cause.
Underwriters Laboratories (UL), a world leader in safety testing and certification released the first in a series of white papers that review evolving battery technology.
This paper explores many of the issues and opportunities associated with the new technology as well as current and recommended safety standards to address changes in the technology and use.
Lithium-ion battery technologies have evolved over the last two decades, with batteries now offering longer cycle life and improved reliability for products in the areas of consumer electronics, medical devices, industrial equipment and automotive applications. In the white paper, UL explains the need for risk assessment as part of the product design and development process to identify and address root causes of safety issues.
IEC 62368-1 is a new international safety standard for audio/video, IT, and communications equipment that was approved in 2010. It consolidates two previous standards to accommodate converging technologies and integrated products. The standard was developed over eight years by IEC TC108 to provide a single standard covering a broad range of products. It uses hazard-based criteria and either prescriptive or performance-based requirements to address safety concerns while allowing for future innovations. A five-year transition period allows manufacturers time to implement the new standard.
5-hydroxytryptamine or 5-HT or Serotonin is a neurotransmitter that serves a range of roles in the human body. It is sometimes referred to as the happy chemical since it promotes overall well-being and happiness.
It is mostly found in the brain, intestines, and blood platelets.
5-HT is utilised to transport messages between nerve cells, is known to be involved in smooth muscle contraction, and adds to overall well-being and pleasure, among other benefits. 5-HT regulates the body's sleep-wake cycles and internal clock by acting as a precursor to melatonin.
It is hypothesised to regulate hunger, emotions, motor, cognitive, and autonomic processes.
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share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
• Evidence-based strategies to address health misinformation effectively
• Building trust with communities online and offline
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• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
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These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
2. Medical Device Approvals in Brazil: A Review and Update
Medical Device Approvals in Brazil:
A Review and Update
With a population of more than 190 million people and a mature healthcare system,
Brazil represents the largest medical equipment market in South America and one of
the largest markets in the world1. Manufacturers seeking to expand their market reach
by selling medical devices in Brazil will encounter an evolving regulatory approvals
system, including mandatory device registration. Because the Brazilian market
represents such a significant opportunity, manufacturers of medical devices can
benefit from understanding both the regulatory requirements and the registration
and certification process for their products.
This UL white paper reviews Brazil’s current regulatory framework for medical
devices, and the requirements for those entities seeking to manufacture, import or
sell medical devices in the country. It also discusses the registration and certification
process required of all device manufacturers, importers and distributors, and the
steps necessary to secure and maintain approval for medical devices. This white
paper includes information on requirements found in RDC 27/IN-3 and Resolution 350,
published by Brazilian regulatory authorities in June 2011.
Regulatory Background
Resolution RDC No. 185 of October 22, 20012 is the primary regulation applicable to the
registration of all medical devices, except for in vitro diagnostic (IVD) devices, which
are covered by Resolution RDC No. 206 of November 2006. RDC No. 185 describes the
applicable device registration protocol and lists the documents required to legally
register a medical device in Brazil. Annex II of RDC No. 185 describes the classification
structure applicable to medical devices, assigning medical devices to one of four
distinct risk classes (I, II, III and IV) according to 18 different rules. The classification
structure for medical devices in Brazil corresponds to that used in the European Union
(EU) under Council Directive 93/42/EEC concerning medical devices.
page 2
3. Medical Device Approvals in Brazil: A Review and Update
Brazil is a member of the Southern companies based elsewhere that do not 2. Certificate of Good Manufacturing
Common Market, also known as have subsidiaries in Brazil must depend Practice (GMP)
MERCOSUR, which includes the countries on Brazilian-based third parties, such 3. Instructions manual in Portuguese
of Argentina, Paraguay and Uruguay. As as hosting companies, distributors and
4. Labeling and packaging
such, the process for the registration of dealers, to obtain ANVISA registration
medical devices in Brazil has been partially for medical devices. Under such an 5. Letter from the device
harmonized with that of these countries, arrangement, the local third party manufacturer, authorizing a
theoretically easing the process of gaining holds the ANVISA registration, and a Brazilian company to hold the
admission to these other markets. manufacturer must maintain an effective product registration and distribute
a device
commercial relationship with a third party
ANVISA Registration Process to ensure the ongoing maintenance of a 6. Clinical trials (sometimes it can
All medical devices imported into or registration. Otherwise, a manufacturer be replaced by the INMETRO
distributed within Brazil must first be will need to repeat the registration certification or literature proving
registered with the Agência Nacional process with another local third party to the effectiveness of the device)
de Vigilância Sanitária, also known maintain market access. 7. List of all device accessories
as ANVISA or the National Health
The registration of most Class 1 and 2 8. For some devices, such as
Surveillance Agency. Established in
devices involves a relatively simple implantable medical devices,
19993 under Brazil’s Ministry of Health,
application process – referred to as cardiovascular products, high-risk
ANVISA is an independently administered,
“cadastro,” meaning “abbreviated IVDs, dialysis equipment and
financially autonomous regulatory
registration” – based on the low to personal hearing aid systems, an
agency responsible for the regulation
moderate risk associated with devices Economic Information Report
and oversight of medical devices
and other medical products in Brazil. in these classes. However, based on the 9. INMETRO certificate,
Specifically, ANVISA is responsible for the greater degree of risk associated with when applicable
registration of medical devices and for their use, a more rigorous process applies
to some Class 1 and Class 2 medical The complete set of documentation
the maintenance of a registered products
devices, as well as all Class 3 and Class 4 depends on the nature of the device, e.g.,
database4. Unlike the EU Notified
devices. In these cases, the party applying IVD devices, implants, electro-medical
Body system, the 510(k) system of the
devices, etc. Defining the exact package
Food and Drug Administration (FDA) for ANVISA registration may be required
of documentation is a complex process,
in the United States, or the Canadian to provide some or all of the following
and requires consulting various laws
Medical Device Conformity Assessment documentation with an application,
and decrees (Law 6360:1976, RDC No.
System (CMDCAS), ANVISA performs all depending on the device characteristics
185:2001 and RDC No. 59:2000). The
registration and inspection functions and classification:
documentation list above applies to the
within the agency.
1. Free sales certificate (it can majority of medical devices; in practice,
Only companies based in Brazil can be replaced by the INMETRO however, required documentation can be
apply for ANVISA registration. Therefore, certificate when applicable) much more extensive.
page 3
4. Medical Device Approvals in Brazil: A Review and Update
GMP Inspection responsible for accrediting certification • NBR ISO 7785-1:1999:
and Certification organizations that certify products for Dental handpieces – Part 1:
compliance with applicable requirements High-speed air turbine handpieces
GMP certification based on an inspection
and authorize the use of approved
conducted by ANVISA is required for • NBR ISO 7785-2:2004:
certification marks. This certification
registration (RDC No. 25, May 21, 2009). Dental handpieces –
scheme is known as the Brazilian
The GMP certificate must be submitted Part 2: Straight and geared
Conformity Assessment System (SBAC).
with the registration application for all angle handpieces
UL has been accredited by INMETRO
Class III and IV devices, as well as for Class
to evaluate and test products, devices, • NBR ISO 9680:2001:
I and II devices noted on the Exemption
equipment, material, processes and Dentistry - Operating lights
List (Instruction IN-2, June 6, 2011). GMP
services for compliance with the • NBR ISO 9919:1997: Medical
inspections are also required to revalidate
standards recognized by SBAC. electrical equipment – Particular
or update existing registrations. The
GMP certificate is valid for two years, To qualify for INMETRO certification, requirements for the basic safety
and ANVISA alone determines whether medical device manufacturers must have and essential performance of
subsequent evaluations can be completed their products tested to SBAC-recognized pulse oximeter equipment for
remotely through a paperwork audit. The standards by an INMETRO-accredited medical use
application for GMP should contain the testing laboratory. The Associação • NBR ISO 11195:2000: Gas mixers
following documentation: Brasileira de Normas Técnicas, also for medical use – Stand-alone
known as ABNT or the Brazilian gas mixers
• Device description and indication
Association for Technical Standards,
of risk class • NBR ISO 8835-2:2010: Inhalational
is responsible for the approval of all
• Complete flow chart describing anaesthesia systems – Part 2:
standards and for the application of any
the relationship with third-party Anaesthetic breathing systems
national deviations, typically limited to
manufacturers, if any translation of a standard into Portuguese. • NBR IEC 61689:1998: Ultrasonics
• Payment receipt for the GMP ABNT approved standards are generally – Physiotherapy systems – Field
inspection fee preceded by an NBR designation. specifications and methods of
measurement in the frequency
• The GMP inspection check for Consistent with the requirements of
range 0.5 MHz to 5 MHz
compliance with RDC No. 59 RDC No. 27 and IN-3 published in June
2011, all medical devices sold in Brazil Importantly, under RDC No. 27 and
INMETRO Certification Process that fall under the scope of the following Instruction IN-3, the third edition of IEC
Brazil’s Instituto Nacional de Metrologia, standards must be INMETRO certified: 60601-1 is now acceptable in Brazil for
Normalização e Qualidade Industrial, INMETRO certification. This is a significant
• NBR IEC 60601 series
also known as INMETRO or the National change from RCD No. 32 that omitted
Institute of Metrology, Standardization • NBR ISO 6875:1998: the third edition of IEC 60601-1 from the
and Industrial Quality, is the body Dental patient chair Brazilian certification scheme.
page 4
5. Medical Device Approvals in Brazil: A Review and Update
Steps to INMETRO Certification
Once a medical device has been tested to the requirements of the appropriate technical
standard and all user manuals have been translated into Portuguese, an applicant can
proceed with the INMETRO certification process. The INMETRO-accredited certification
body will then conduct the steps described in the following sections.
1: Documentation Analysis
First, the certification body will review the product documentation, consisting of
the following:
• User manuals translated into Portuguese
• Quality manual and master control list of a manufacturer’s quality
management system
• Some certification agencies will accept a manufacturer’s test reports, such as
IECEE CB Scheme test reports, that have been issued within the past two years.
Other test that are acceptable to a wider range of certification agencies include
reports issued by organizations accredited by signatories of the International
Laboratory Accreditation Cooperation (ILAC), including the American Association
for Laboratory Accreditation (A2LA) and the U.S. National Voluntary Laboratory
Accreditation Program (NVLAP).
• If a device remains unchanged since the test reports were originally issued,
a manufacturer should provide a declaration to that effect
The certification body will review the test reports to assess whether a medical device
has been completely evaluated to all applicable standards, including collateral and
particular standards, and complete any additional tests that might be required.
During this analysis, the certification body may also create a file that contains
technical information about a device, including a list of critical components. When the
certification body is satisfied that a product complies with applicable requirements,
a pre-license inspection is performed.
page 5
6. Medical Device Approvals in Brazil: A Review and Update
2: Pre-License Inspection 8.2.4: Monitoring and measurement manufacturer are compliant with all
of product applicable requirements, the certification
This factory inspection is similar to
body issues an INMETRO certificate.
CENELEC’s Common Interest Group 8.3: Control of nonconforming product
An INMETRO certificate is valid for five
(CIG) 23 quality inspection. The scope
8.5.2: Corrective action years, and evidence of the certification
of the pre-license inspection includes
In addition to the ISO clauses above, is published in INMETRO’s directory of
verification of compliance with the
an auditor conducting a pre-license approved products. In addition, evidence
following clauses of ISO 13485:2003:
inspection will look for evidence that of certification may also be published by
4.2.3: Control of documents the following production tests are being the certification body in its own directory
4.2.4: Control of records performed by a manufacturer on 100% of approved products.
of those medical devices bearing the At the end of a certification process,
7.1: Planning of product realization
INMETRO mark: an applicant is authorized to use
7.2.3: Customer communication
• Leakage current certification marks to demonstrate a
7.3.6: Design and development validation (earth, enclosure, patient) device’s compliance (examples of marks
7.3.7: Control of design and (Clause 19 of IEC 60601-1) issued by UL are shown in Figure 1).
These marks should be placed on both
development changes • Earthing
the approved medical device and on the
7.4.3: Verification of purchased product (protective/functional and
product packaging. The orange-colored,
potential equalization)
7.5.1: Control of production and rectangular mark should be a minimum
(Clause 18 of IEC 60601-1)
service provision of 50 mm in size. The black and white
• Dielectric strength marks with the wording INMETRO and
7.5.2: Validation of processes for
(Clause 20 of IEC 60601-1) OCP-0029 should be at least 22 mm. The
production and service provision
• Functional test smallest mark with the word SEGURANÇA
7.5.3: Identification and traceability should be at least 11 mm. These two
3: Certification and Product Marking
7.5.5: Preservation of product smaller marks are used only in cases
After a certification body has where there is insufficient space for the
7.6: Control of monitoring and
completed its review of test reports largest rectangular mark. The certification
measuring devices
and user manuals as well as its body should provide instructions for
8.2.3: Monitoring and measurement pre-license factory inspection and has appropriate use of the certification marks
of processes determined that a device and the device as well as artwork for printing purposes.
Figure 1: INMETRO Certification Marks
page 6
7. Medical Device Approvals in Brazil: A Review and Update
Annual Inspection
Like most other product certification
systems, maintaining an INMETRO
certification requires certain periodic
activities. For an approved medical
device to remain INMETRO certified for
the full five year certification period,
a manufacturer’s facility is subject to
annual surveillance inspections. An
annual INMETRO inspection should take
place approximately 12 months after the
original certification has been issued and
at succeeding 12 month intervals for the
duration of the certification period. For
example, for a certification originally
issued in November 2010, the first
annual surveillance inspection would be
conducted around November 2011, and
again in November 2012, November 2013
and November 2014.
When a certification body has locally
qualified staff and facilities, the annual
INMETRO surveillance inspections can be
conducted by local assessors. The scope to issue CB Test Reports or that is ILAC Companies that do not comply with
of these annual maintenance inspections accredited. A device needs to be retested the approval requirements for medical
is the same as the pre-license inspection even if its design is unchanged since the devices can face severe penalties, from
conducted at the beginning of the financial assessments to the confiscation
initial product approval.
certification process. of unapproved products. Customs
Recertification Other Issues and Concerns officials in Brazil will only authorize the
importation of products after consulting
As previously mentioned, the INMETRO Most safety certifications provide
with ANVISA’s approved products
certificate is valid for a period of five testing to a base standard and applicable
database to ensure that a product has
years, after which a device must be particular standards. ANVISA requires
been properly registered. In case of
recertified. If a certificate holder wishes products to be tested to most of the doubt, customs officials will typically
to renew a medical device certification for particular and collateral standards, hold all products at an owner’s expense
additional five year term, a device needs including IEC 60601-1-2 (EMC) and IEC until registration and certification can
to be fully retested by any laboratory able 60601-1-4 (software). be verified.
page 7