Full description of the regulatory process for the medical devices registration in South Korea. It contains information about: classification, substantial equivalence, product license, testing, Korean Good Manufacturing Practice (KGMP)...
Find more on: http://kobridgeconsulting.com/?p=767
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Pallavi Christeen
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member’s states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.
Key Words: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.
Submission requirements and Purpose, Details of Submission requirements and strategies, Submission timelines and cost, Differences between Japan and US submission processes
NOTE - This presentation was made as part of an assignment for a Course PME 542 (Regulation and Compliance in the Pharmaceutical Industry) at Stevens Institute of Technology, Hoboken, New Jersey
Prepared By - Ravi Goswami, Darold Hill, Shobha Dalal and Kuldeep Badoniya
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Pallavi Christeen
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member’s states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.
Key Words: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.
Submission requirements and Purpose, Details of Submission requirements and strategies, Submission timelines and cost, Differences between Japan and US submission processes
NOTE - This presentation was made as part of an assignment for a Course PME 542 (Regulation and Compliance in the Pharmaceutical Industry) at Stevens Institute of Technology, Hoboken, New Jersey
Prepared By - Ravi Goswami, Darold Hill, Shobha Dalal and Kuldeep Badoniya
Food Safety Modernization Act (FSMA), a system in which the food industry systematically puts in place measures proven effective in preventing contaminations. http://www.foodsafetyspecialists.com/consulting.htm
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Japan Medical Device Regulatory Approval ProcessKate Jablonski
Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, outlines some of the most complex aspects of the Japanese registration process, including:
JMDN codes: device classification and predicates
Clinical data requirements and PMDA pre-submission meetings
Registration routes (Todokede, Ninsho, Shonin)
QMS (Ordinance 169) requirements
Role of the Marketing Authorization Holder (MAH)
Medical Devices Rules 2017 Implementationshashi sinha
Medical Devices Rules are now enforced for all medical devices. It is important to know about the MDR 2017 and how it affects the Manufacturers, Importers and Distributors of Medical Devices and status of implementation.
Presentation about license holder in Korea for medical devices manufacturers. Folling sections are covered:
Definitions
Duties of parties involved
Changing representation
Becoming license holder
Distributing products
Impact on KGMP
Different options
Food Safety Modernization Act (FSMA), a system in which the food industry systematically puts in place measures proven effective in preventing contaminations. http://www.foodsafetyspecialists.com/consulting.htm
Quality System Requirements 21 CFR Part 820 and Labelling Requirements for Me...Swapnil Fernandes
Covers the following details -
- What is QMS ?
- QMS subparts
- QMS Inspection
- What is a label ?
- What is labelling ?
- Labelling requirements and regulations
- Labelling based on the types of submission
Regulatory requirnment and approval procedure of drugs in japan pptsandeep bansal
this ppt is about all the rules and regulations of drugs in Japan.this ppt contains the PMDA structure, DMF data, IND and NDA procedure, cosmetic regulations, post marketing survelliance etc.
Japan Medical Device Regulatory Approval ProcessKate Jablonski
Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, outlines some of the most complex aspects of the Japanese registration process, including:
JMDN codes: device classification and predicates
Clinical data requirements and PMDA pre-submission meetings
Registration routes (Todokede, Ninsho, Shonin)
QMS (Ordinance 169) requirements
Role of the Marketing Authorization Holder (MAH)
Medical Devices Rules 2017 Implementationshashi sinha
Medical Devices Rules are now enforced for all medical devices. It is important to know about the MDR 2017 and how it affects the Manufacturers, Importers and Distributors of Medical Devices and status of implementation.
Presentation about license holder in Korea for medical devices manufacturers. Folling sections are covered:
Definitions
Duties of parties involved
Changing representation
Becoming license holder
Distributing products
Impact on KGMP
Different options
Health Policy Supporting Innovation in Korean Medical Device Sector (July 11,...Sung Yoon Bae
Presented in the AMCHAM Healthcare Innovation Seminar, held in Seoul, Korea on July 11, 2012.
Title: Toward Better Health Policy Supporting Innovation in Korean Medical Device Sector
Date: July 11, 2012
Speaker, Sung Yoon Bae, Professor of Healthcare Management, Inje University, Busan, Korea
Strategies for Device Approval in China, India, South Korea and AustraliaApril Bright
This session will describe the orthopaedic device regulatory and registration requirements in Asia Pacific markets. Regulatory steps and strategies will be presented for each of these countries. The discussion will also cover ways to gain regulatory information about competitors already selling in these markets. Attendees will leave the session with an understanding of timelines, costs and complexity for approval.
Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India.
Indian market overview
India’s medical device regulatory structure
Categories of regulated medical devices in India
No Objection Certificates
Device Registration Certificate applications
Import Licensing
India Authorized Agent selection
Costs and Timelines
Developing Regulatory Issues in India
“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.
FDA classify Medical Devices and how to report device problems A Systematic R...Pubrica
The typical time it takes to get a device to market is 3 to 7 years, compared to 12 years for pharmaceuticals. However, there are concerns that the Food and Drug Administration's Systematic Review Writing methods may not be adequate to satisfy the required guarantees of safety and efficacy.
Learn More : https://pubrica.com/services/research-services/systematic-review/
Reference: https://bit.ly/3xNHUsC
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When you order our services, we promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Bio statistical experts | High-quality Subject Matter Experts.
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COMMON REGULATORY AFFAIRS JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated in 2022!Pristyn Research Solutions
COMMON REGULATORY AFFAIRS
JOB INTERVIEW QUESTIONS WITH
ANSWERS By Pristyn Research-Updated 2022.
A quick Job interview short guide For Pharma and all
Life science jobseekers.
info.pristynresearch.com
www.pristynresearch.com
9028839789 | 8999717656
All Medical | Biotech |Micro |B.Sc., M.Sc.
PAN India DRA companies
list alphabetically
FDA classify Medical Devices and how to report device problems A Systematic R...Pubrica
The typical time it takes to get a device to market is 3 to 7 years, compared to 12 years for pharmaceuticals. However, there are concerns that the Food and Drug Administration's Systematic Review Writing methods may not be adequate to satisfy the required guarantees of safety and efficacy.
Learn More : https://pubrica.com/services/research-services/systematic-review/
Reference: https://bit.ly/3xNHUsC
Why Pubrica:
When you order our services, we promise you the following – Plagiarism free | always on Time | 24*7 customer support | Written to international Standard | Unlimited Revisions support | Medical writing Expert | Publication Support | Bio statistical experts | High-quality Subject Matter Experts.
Contact us:
Web: https://pubrica.com/
Blog: https://pubrica.com/academy/
Email: sales@pubrica.com
WhatsApp : +91 9884350006
United Kingdom: +44-1618186353
The United States has always been and remains to be the leading place
for the conduct of clinical trials. According to Clinicaltrials.gov, the largest
clinical trials registry, 32% of registered clinical trials were conducted in
the U.S. as of May 2022 (1). Factors such as the availability of qualified
healthcare professionals, high-quality infrastructure and facilities,
cutting-edge research, an efficient regulatory system, and a high
standard of ethics and participant protection make the U.S. the leading
country for clinical trials.
Clinical trials follow extensive preclinical research to test the safety and
efficacy of a new drug, medical device, or biological in humans. They are
usually divided into three phases: phases I, II, and III which are designed
to ascertain safety, pharmacokinetics, efficacy, dosage, and adverse
events. Figure 1 shows the typical route from discovery and preclinical
studies to the post-marketing phase (phase IV).Clinical trials represent the longest and most expensive step in bringing
drugs to the market and have the highest attrition rate, only 10% of drugs
that enter phase I trials are granted marketing approval. Therefore,
clinical trials should be conducted by experts that are
well-versed with all the regulations and guidelines in a particular region to
boost the chances of drug approval.
The United States Food and Drug Administration (US FDA) is the
regulatory body that approves and oversees the conduct of clinical trials
for drugs, medical devices, and biologicals that are intended to be
marketed in the U.S and is touted to have the most stringent standards
for drug approval. The primary role of the FDA is to protect public health
by ensuring that medicinal products and devices are safe and efficacious.
Therefore, it is necessary for sponsors/investigators or contract research
organizations (CRO) that are conducting clinical trials to be familiar with
regulations and guidances that govern the conduct of clinical trials.Conducting a clinical trial in the United States requires a deep understanding of the
regulations and guidelines set by the FDA. It is important to know what is needed for a
successful clinical trial, from selecting an appropriate study site to obtaining informed
consent from participants. Additionally, it is essential to understand the requirements for data
collection and analysis, as well as how to develop an effective protocol. Clinical trial services
in USA can provide guidance on all of these aspects and more, helping you ensure that your
clinical trial meets all necessary standards
Clinical research : Drug regulatory affairs and Pharmacovigilance.ProfDnyaneshwariJosh
Schedule Y, FDA, Appendices, Post marketing surveillance,Clinical trial,WHO,ICH-GCP, FDA-CFR, Safety,Adverse Drug reaction, Adverse Event(AE), Serious Adverse Event(SAE),Reporting, IND , 3500A form
Similar to Kobridge medical devices registration in South Korea (20)
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
Health Education on prevention of hypertensionRadhika kulvi
Hypertension is a chronic condition of concern due to its role in the causation of coronary heart diseases. Hypertension is a worldwide epidemic and important risk factor for coronary artery disease, stroke and renal diseases. Blood pressure is the force exerted by the blood against the walls of the blood vessels and is sufficient to maintain tissue perfusion during activity and rest. Hypertension is sustained elevation of BP. In adults, HTN exists when systolic blood pressure is equal to or greater than 140mmHg or diastolic BP is equal to or greater than 90mmHg. The
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
2. Today’s Topics
• Korean medical device market characteristics
• Overview of the Korean regulatory process
• Common framework
• Comparison with US and EU process
• Definitions
• General Steps
• Classification
• Substantial Equivalence
• In-country Representation requirements
• Pre-market process (product license)
• Korea Good Manufacturing Practices (KGMP)
5. The Market
• Similar as US and EU market
• Established market
• Opportunities based on replacement of the installed
base or new technologies
• Very regulated and « Opaque » market
• More similarities with US market and regulations
6. The Market
• Most doctors study in US then expect to find the
same technology in Korea
• High influence on the choice of products by doctors
especially when used in US
• The market path could be then first US clearance and
then South Korea
8. The South Korean Regulatory
Process for Medical Devices
Since 2013:
The former Korea Food and Drug Administration
(KFDA), an agency under MHW, regulating all Medical
Devices was promoted to ministry level: Ministry of
Food and Drug Safety (MFDS).
The legal framework for the regulatory system is
based on the Medical Devices Act No. 10564. Medical
devices must meet the requirements of the Medical
Devices Act, and obtain registration with the MFDS
before being sold in the country.
9. The major steps
1. Determine the class of the product
2. Establish an equivalence
3. Assign a « License Holder »
4. Prepare the file
5. Tests
6. Review (with or without technical file)
7. KGMP certification (if required)
8. Place on the market
11. Where to start
from?
Most applicants have
their products already
registered in US or EU.
Therefore it is useful
whenever possible to do
a comparison analysis
between the 3 markets
13. Interested parties of medical devices
in Korea, EU and USA
Korea EU USA
Medical Device Act Medical Device
Directive
Federal Food Drug &
Cosmetic Act
Manufacturer Manufacturer Manufacturer
Registered Importer Authorised
Representative
U.S. Agents
MFDS Notified Body FDA
Medical Device
Technical Document
Review Agency
Third Party
15. Common framework for medical
device regulations
STAGE PRE-MARKET PLACING ON-MARKET POST-MARKET
CONTROL/
MONITOR
PRODUCT SALE AFTER-SALE/USE
PERSON MANUFACTURER VENDOR VENDOR/USER
Items or activities
regulated
Device attributes
• Safety and performance
Establishment registration
• List products available or
in use
• Requires vendor to fulfill
after-sale obligations
Surveillance/vigilance
• After-sale obligations
• Monitoring of device’s
clinical performance
• Problemidentification
and alerts
Manufacturing
• Quality systems
Labelling
• Accurate description of
product
• Instructions for use
Advertising
• Prohibits misleading or
fraudulent advertisement
17. Definition of Medical Device
Korea (Medical Device Act) - Chapter1, Article 2
For the purpose of this Act, the term "medical device" means any instrument,
machine, contrivance, material or similar article that is used on human beings or
animals either alone or in combination with other devices and that falls under any of
the following Items provided below. However, drugs or quasi-drugs under the
Pharmaceutical Affairs Act or, among the disabled-assistive-devices under Article 65 of
the Act for Welfare of the Disabled, artificial limbs and orthotics shall be excluded:
1. Articles used for the purpose of diagnosis, cure, alleviation, treatment, or prevention
of illness;
2. Articles used for the purpose of diagnosis, cure or alleviation of or compensation for
an injury or disability;
3. Articles used for the purpose of test, replacement, or modification of the structure
or functions [of the body]; or
4. Articles used for the purpose of control of conception.
18. Definition of Medical Device
EU(MedicalDevice Directive –93/42/EEC amended by 2007/47/EC) - Article 1
‘medical device’ means any instrument, apparatus, appliance, software, material or
other article, whether used alone or in combination, including the software intended
by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes
and necessary for its proper application, intended by the manufacturer to be used for
human beings for the purpose of:
-diagnosis, prevention, monitoring, treatment or alleviation of disease,
-diagnosis, monitoring, treatment, alleviation of or compensation for an injury or
handicap,
-investigation, replacement or modification of the anatomy or of a physiological
process,
-control of conception,
and which does not achieve its principal intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its
function by such means;
19. USA (the Federal Food Drug & Cosmetic Act) - 201(h)
A device is"an instrument, apparatus, implement, machine, contrivance, implant, in
vitro reagent, or other similar or related article, including a component part, or
accessory which is:
•recognized in the official National Formulary, or the United States Pharmacopoeia,
or any supplement to them,
•intended for use in the diagnosis of disease or other conditions, or in the cure,
mitigation, treatment, or prevention of disease, in man or other animals, or
•intended to affect the structure or any function of the body of man or other animals,
and which does not achieve any of it's primary intended purposes through chemical
action within or on the body of man or other animals and which is not dependent
upon being metabolized for the achievement of any of its primary intended
purposes."
Definition of Medical Device
20. Definition of Medical Device
Comments on the different definitions
The main difference between the Korean definition
and the other two is:
In Korea, drugs and quasi-drugs are exclude from the
scope of the medical devices
Caution: some gels, lotions or similar product could fall
in that category
24. Device Status and Classification
Class 1
(low risk)
Class 2
(Medium
Risk)
Class 3
(Medium-
High Risk)
Class 4
(High Risk)
Increasing risk for the patient
25. Classification of Medical Device
Korea EU USA
KFDA Notification No.
2010-91
MDD Annex IX 21 CFR 862-892
Class 1
Class 2
Class 3
Class 4
Class I , Class I (sterile,
measure)*
Class IIa
Class IIb
Class III
Class I
Class II
Class III
Classification of
medical devices are
already defined
Classify according to
the classification Rule
(Rule 1 ~ Rule 18)
Classification of
medical devices are
already defined
26. Conformity assessment procedure
Class of
medical devices
Risk classification Approval or Certification
Class 4 High risk Product approval by MFDS
Clinical data
Class 3 Medium risk Product approval by MFDS
Class 2 Low risk Product approval by MFDS
Technical document review
by 3rd Party
Class 1 Extremely low risk Product notification to
MFDS
28. MFDS Substantial Equivalence (SE)
Substantial equivalency is supported by proper scientific
rationale or supporting documents. A comparison table
exists for each category of product with the following
criteria:
Intended use
Principle of action
Raw material (for patient contact)
Performance
Testing method / standard
Instruction for use
29. MFDS Substantial Equivalence (SE)
If the device has a substantial equivalent already sold in
Korea no SER (Safety and Effectiveness Review) is
needed.
On the contrary SER is required if the equivalency
cannot be proven.
30. Classification of Medical Device
Korea EU USA
Substantial Equivalence
(SE)
None Predicate Device
SER (Safety and
Effectiveness Review)
None PMA (Pre-Market
Application)
33. Korea License Holder Requirements
The role of the Korea License Holder (KLH) is to
coordinates and submits your medical device
registration application to the MFDS on your behalf.
It is essential to appoint a KLH as your representative
if you don’t have any local business in South Korea
34. The strategy
3 Options:
Distributor only (the distributor takes care of everything):
registration, licenses, post-market follow-up, sales,
marketing
License holder + distributor: same as above except license
holder does registration, licenses, post-market follow-up
Subsidiary: establish your subsidiary in South Korea. The
subsidiary becomes the license holder. A consultant takes
care of the registration.
35. Different entities involved
Korea EU USA
Medical Device Act Medical device, in-vitro
diagnostic directives
Federal Food Drug &
Cosmetic Act
Manufacturer Manufacturer Manufacturer
License Holder European
Representative
U.S. Agents
MFDS Notified Body FDA
Third Party Third Party
37. Class I Devices: Premarket
Notification
• Class I standard device
applications are considered
accepted to the MFDS branch
office
• The Premarket Notification
contains basic information on
your medical device
38. General Technical File Preparation
For Class II, III and IV medical devices
with proven Substantial Equivalence,
manufacturers must prepare a
General Technical File.
The General Technical File is similar to
a US FDA 510(k) submission.
39. Safety and Effectiveness Review
(SER) Technical File Preparation
Manufacturers of Class II, III
and IV devices without
Substantial Equivalence must
prepare SER Technical File
submissions.
The SER Technical File is
similar to the US Premarket
Notification submission.
40. SER Technical File Preparation:
Clinical Data Requirements
• Clinical data must be included in SER Technical File
submissions to the MFDS
• Clinical trials in Korea are typically not required
• KFDA often accepts clinical data that has already been
approved by an OECD member country or published
in an SCI-listed scientific journal
41. Type Testing Requirements
• All Class II, III and IV medical
devices must undergo type
testing by an independent
laboratory.
• Existing equivalent product
testing may meet this
requirement, as long as it
complies with ISO, IEC, ASTM or
GLP standards.
42. MFDS Certified Test Laboratories
14 certified test laboratories
Some of them have a full scope
Other have limited scope
Some are specialized in dental products
Determination of the acceptance of foreign test
reports made by MFDS-authorized test labs
43. Technical File Submissions
Once your Technical File is prepared, it must be
submitted to the appropriate reviewer for approval.
Class 2: reviewed by 3rd party, approved by MFDS
Class 2,3,4 (SER or not): reviewed and approved by
MFDS
44. KFDA Regulatory Timeframes and
Costs
MFDS
Classification
Review Time Fees
Class 1 NA $35
Class 2 35 days $1500
Class 2 SER 80 days $450
Class 3 and 4 65 days $195
Class 3 and 4
80 days $450
SER
45. MFDS Authorized Third-Party
Reviewers
There are 6 companies authorized by the MFDS to
perform reviews of Class 2 General Technical Files. It
includes:
Notified Bodies
Korean test laboratories
46. Product License
Once the technical file (SER or not) is approved, the
submission process continues in order to obtain the
product license
It is recommended to submit at the same time the
request for KGMP certificate
49. Korea Good Manufacturing Practices
(KGMP)
Korea EU US
KFDA Notification No.
2010-93(Amended on
December 27, 2010)
Standards for
Manufacture, Import and
Quality Management of
Medical Device
EN ISO 13485: 2012 21 CFR Part 820
Quality System
Regulation (QS)/
Good Manufacturing
Practices (GMP)
Annex II
Section 3 (Quality system)
Section 5 (Surveillance)
Annex V
Section 3 (Quality system)
Section 4 (Surveillance)
Annex VI
Section 3 (Quality system)
Section 4 (Surveillance)
50. Korea Good Manufacturing Practices
(KGMP)
Manufacturers of class 2, class 3 and class 4 are
required to comply with KGMP requirements
The quality system compliant with KGMP is very much
similar to ISO 13485
Onsite verification of the data from the Device Master
Record
51. KGMP Certification Process
Preparation of the documents
Submission 2 months before the expected date of the
inspection (in parallel with the submission of the
technical file)
Review by 3rd Party and MFDS
Onsite Inspection
Issue the certificate (valid 3 years)
52. KGMP Certification Process
KGMP inspections are performed by MFDS inspector
and 3rd Party
4 Korean laboratories are accredited to perform
KGMP inspection
53. Final registration
Following the approval, MFDS delivers a
product license and a KGMP certificate
Customs clearance of the product is done
by the “license holder”
54. Thank You !
Nicolas Clary
Kobridge Consulting
+82 2 3450 1690
Nicolas.clary@kobridgeconsulting.com
www.kobridgeconsulting.com