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.
An electronic health record (EHR) is a collection of patient’s electronically-stored health information in a digital and systematic format. EHR system can store data accurately.
Medical device industry 2014 - A Healthcare Sector AnalysisVikas Soni
Medical Device Industry and its impact on Healthcare Sector of India for FY2014 along with Current Scenario of Global, US, EU and Indian Medical device market.
An electronic health record (EHR) is a collection of patient’s electronically-stored health information in a digital and systematic format. EHR system can store data accurately.
Medical device industry 2014 - A Healthcare Sector AnalysisVikas Soni
Medical Device Industry and its impact on Healthcare Sector of India for FY2014 along with Current Scenario of Global, US, EU and Indian Medical device market.
This presentation talks about the context of developing the Electronic Health records for India. the guidelines as mentioned in the GOI site is described vividly with examples, for better understanding.
N.B: Please download the ppt first, for the animations to work better.
NABH 5th edition hospital std april 2020anjalatchi
A. National Accreditation Board for Hospitals & Healthcare Providers (NABH) is a constituent board of Quality Council of India (QCI), set up to establish and operate accreditation programme for healthcare organizations.
SIM Unit 4
Store management :
Materials handling,
Flow of goods/FIFO,
Computerization of inventory transactions
Security of stores,
Stocking and technical impacts-
shelf life,
wastage,
pilferage
In this, we will read about the Supply Chain Management in Healthcare
The following contents will be described briefly:-
1. What is a supply chain?
2. The process of Views of Supply Chain
3. Objectives of Supply Chain Management
4. Supply Chain Decisions
5. Benefits of Supply Chain
6. Integrated Health Supply Chains
7. New Trends In Healthcare Supply Chain
8. Potential Risks to an Organization and Supply Chain
9. Strategies to Improve Healthcare Supply Chain Management
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 presentation talks about the context of developing the Electronic Health records for India. the guidelines as mentioned in the GOI site is described vividly with examples, for better understanding.
N.B: Please download the ppt first, for the animations to work better.
NABH 5th edition hospital std april 2020anjalatchi
A. National Accreditation Board for Hospitals & Healthcare Providers (NABH) is a constituent board of Quality Council of India (QCI), set up to establish and operate accreditation programme for healthcare organizations.
SIM Unit 4
Store management :
Materials handling,
Flow of goods/FIFO,
Computerization of inventory transactions
Security of stores,
Stocking and technical impacts-
shelf life,
wastage,
pilferage
In this, we will read about the Supply Chain Management in Healthcare
The following contents will be described briefly:-
1. What is a supply chain?
2. The process of Views of Supply Chain
3. Objectives of Supply Chain Management
4. Supply Chain Decisions
5. Benefits of Supply Chain
6. Integrated Health Supply Chains
7. New Trends In Healthcare Supply Chain
8. Potential Risks to an Organization and Supply Chain
9. Strategies to Improve Healthcare Supply Chain Management
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.
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.
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
This Circular provides for emergency marketing authorization of COVID-19 vaccines (hereinafter referred to as “vaccines"), specifically:
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2. Requirements for clinical data in applications to ensure vaccine safety and effectiveness.
3. Exemption from one or more than one clinical trial phase and vaccines required to undergo phase 4 clinical trial in Vietnam.
Presentation: MMDR reform - Patient Implant Cards and Information LeafletsTGA Australia
The TGA has introduced a new regulatory requirement for manufacturers of implantable medical devices to provide patient implant cards and patient information leaflets with their devices. The implementation period starts from December 2018 for some devices and will apply to all implantable devices by December 2021. The TGA is engaging with health care systems to determine the best method of delivery of these resources to patients.
“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.
the overall summary of regulation of herbal drugs in India and what document required for getting approval and summary of GMP, GCP guideline with labelling requirement.
FDA expanding the capability of remote ophthalmic assessment and monitoring devices and Tonometers may help facilitate patient care while reducing patient and healthcare provider contact and risk of exposure to SARS-CoV-2. Recommended modification for device function/indications provided in Table 1 and labeling modification
Presentation: Update from the Medical Devices BranchTGA Australia
Under Recommendation 15 of the Review of Medicines and Medical Review Regulation (MMDR) the Government agreed to greater utilisation of marketing approvals by comparable overseas regulators to support assessments of medical devices in Australia. Legislative amendments in the Therapeutic Goods Amendment (2017 Measures No. 1) Act 2018 to enact this change also included clarifications regarding preliminary assessment of applications for pre-market authorisation. This presentation will review the implementation arrangements for these changes, covering the increased options for use of overseas approvals, and the evidence requirements to support applications.
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
Circular 10/2023/TT-BYT, issued May 11, 2023: Amendments to Article 3 of Circular No. 19/2021/TT-BYT dated November 16, 2021 of the Minister of Health on templates of documents and reports on implementation of Decree No. 98/2021/ND-CP dated November 08, 2021 of the Government on management of medical devices
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
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A personal brand exploration presentation summarizes an individual's unique qualities and goals, covering strengths, values, passions, and target audience. It helps individuals understand what makes them stand out, their desired image, and how they aim to achieve it.
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Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
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Memorandum Of Association Constitution of Company.pptseri bangash
www.seribangash.com
A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
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Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
https://seribangash.com/article-of-association-is-legal-doc-of-company/
Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
www.seribangash.com
Liability Clause: It outlines the extent of liability of the company's members. In the case of companies limited by shares, the liability of members is limited to the amount unpaid on their shares. For companies limited by guarantee, members' liability is limited to the amount they undertake to contribute if the company is wound up.
https://seribangash.com/promotors-is-person-conceived-formation-company/
Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
Importance of Memorandum of Association:
Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
https://seribangash.com/difference-public-and-private-company-law/
Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
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While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
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Guidelines for import and manufacture of medical devices
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GUIDELINES FOR IMPORT AND MANUFACTURE OF MEDICAL DEVICES
The Ministry of Health and F.W. under Gazette notification S.O. 1468 (E) dated 6/10/2005 declared
the following sterile devices to be considered as drugs under Section 3 (b) (iv) of the Act.
1. Cardiac Stents.
2. Drug Eluting Stents.
3. Catheters.
4. Intra Ocular Lenses.
5. I.V. Cannulae.
6. Bone Cements.
7. Heart Valves.
8. Scalp Vein Set.
9. Orthopedic Implants.
10. Internal Prosthetic replacements.
It was also notified vide GSR 627 (E) dated 7/10/2005 that control over manufacture of these
devices would be exercised by CLAA i.e. DCG(I) under the said Rules.
The Ministry of Health and Family Welfare have now approved the following procedures to be
adopted in respect of licensing of import as well as manufacture of these Medical Devices in the country.
These guidelines shall be effective from 1st March 2006.
IMPORT OF MEDICAL DEVICES
For the purpose of import of Devices specified above, the procedure for registration and import
licence as prescribed under the Drugs and Cosmetics Rules shall be followed.
1. A period of 60 days would be provided for the importers to make application for import and
registration from the date of publication of these guidelines.
2. In case of devices which have not been imported in the country before the date of notification
no import would be permitted without the approval of the competent authority.
3. For the time being and for a period upto six months, until an application is approved or
rejected, whichever is earlier, the devices which are currently in use will be permitted to be
sold. In case of stents or drug eluting stents the import will not be permitted if the applicant
has sold less than One thousand stents of the particular specification prior to the date of
issue of these guidelines.
4. Separate committees consisting of subject experts and representative of DCG(I) office would
be setup for their expert advice for evaluation of specific categories of devices. The expert
committees would formulate their own benchmarks and procedures for evaluations and the
standards to which such devices should conform.
REGISTRATION OF MEDICAL DEVICES FOR IMPORT
1. Application for Registration Certificate in respect of the premises and the devices
manufactured by the manufacturer and meant for import into India is required to be made by
the manufacturer or importer or his agent in India, in Form 40 and in form and manner as
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under Rule 24A of the Drugs and Cosmetics Rules. The application addressed to the Drugs
Controller General (India) shall be deposited at the CDSCO, FDA Bhawan, Kotla Road,
Near Mata Sundari College, ITO, New Delhi-110002.
2. A fee of US$ 1500 or its equivalent shall be paid alongwith the application as registration fee
for the premises where the devices, intended to be imported are being manufactured by the
manufacturer.
3. A fee of US$ 1000 or its equivalent shall be paid for registration of single Medical Device
(which may include variation in sizes or shape without any change in the material or method of
use) and an additional fee US$1000 for each additional device shall be paid.
4. The fee shall be paid through a challan in the Bank of Baroda as prescribed under the said
Rules.
5. The informations and undertakings required to be furnished under Schedule DI and DII may
be modified to suit the requirements of devices in place of normal pharmacological products.
The information shall include the following details:-
(A) Applicant Details
1. Applicant’s company name, address and contact number.
2. Name and address of foreign manufacturer (Manufacturing premises).
3. Copy of the Plant Master File.
4. Name and address of the local authorized representative.
5. Name and address of the importer.
6. Local manufacturer, if any processing is being done in the country.
(B) Product Information
1. Proprietary/Brand name.
2. Brief description of the device.
3. Category of device.
4. Intended use and method of use.
5. Medicals specialty in which the device is used.
6. Qualitative and quantitative particulars of the constituents.
7. Brief description of the method of the manufacture and specification of the materials used.
8. Contraindications, warnings, precautions potential adverse events and alternate therapy,
wherever applicable.
9. List of accessories and other devices or equipment to be used in combination with the device.
Other descriptive information, including accessories packaged with the product.
10. Variations in shape, style or size of the device, if applicable.
11. Labeling details conforming to Drugs and Cosmetics Rules, 1945.
12. Physician manual and promotional literature (Literature insert) in English.
13. Packaging description including pack sizes.
14. Recommended storage conditions.
15. Summary indications of any reported problems.
16. Details of standards to which the device conform alongwith the copy of the standard.
(C) Regulatory Status
1. Approval of the product from any other regulatory agency (Separate evidence for the
approval from the each agency)
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(i) US FDA clearance/approval.
(ii) EU medical device directive (CE Certificate).
(iii) Australia/Canada/Japan approval.
(iv) Approval in any other country.
1. Copy of ISO/EN Certification if any for the manufacturing facility.
2. List of countries where the device is being sold.
3. List of countries where device is withdrawn from sale with reasons,
if any.
(D) Master File (Details of Good Manufacturing Practices employed by the
manufacturer to ensure quality of the device)
1. Component/Material used.
2. Device Master File.
3. Manufacturing process/Flow Chart.
4. Quality Assurance procedures/process controls.
5. Final product testing or design inputs/outputs verification, if applicable.
6. Functionality Test protocol and report, if applicable.
7. Risk Assessment as per ISO 14971.
8. Sterilization process and validation/verification.
9. Stability data or statement of established stability of material used as applicable.
10. Shelf life of the device.
11. Biocompatibility and Toxicological data, wherever applicable.
12. Device GMP Certificate.
(E) Devices containing medicinal product
1. If device incorporates a medicinal product, which is liable to act upon the body with action
ancillary to that of the device, data on the safety, quality and usefulness of the medicinal
substance used.
2. Data on compatibility with medicinal products, if device intended to deliver medicinal
products.
3. Clinical data and published articles, if any.
4. Batch Release Certificate for products incorporating any medicinal substance or substances
of animal origin.
5. For devices not approve for marketing in the country of origin, the applicant shall submit
reports of clinical trials, details of sales, certificates of satisfactory use from the medical
specialists about the use of the device and details of product complaints, if any.
(Medical Devices with prior approval from any of the recognized regulatory authorities will be
subjected to an abridged evaluation and only a summary of all the studies and information
described above is to be submitted)
(F) Post Market Surveillance
1. Procedures for distribution of records.
2. Complaint handling.
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3. Adverse incident reporting.
4. Procedure for product recall.
(G) Undertaking of conformity with respect to product standards, safety and
effectiveness requirements and quality systems in the country of origin.
5. The Registration Certificate shall be issued in Form 41 of the said Rules.
6. The application for import licence shall be made in Form 8 alongwith a fee
of Rs. 1000/- in the Form and manner prescribed under the Drugs and
Cosmetics Rules.
MANUFACTURE OF MEDICAL DEVICES IN THE COUNTRY
1. Application for the grant of licence for manufacture of these notified sterile Devices in the
country shall be made in Form 27 to the State Licensing Authority, accompanied by the
requisite fee in the Form and manner as prescribed in the said Rules alongwith a copy to the
office of DCG(I).
2. A period of 60 days would be provided for making the application for manufacture from the
date of publication of these guidelines.
3. In case of devices belonging to above said categories which have not been manufactured in
the country before the date of notification, no manufacture would be permitted hence forth
without the approval of the competent authority as per norms prescribed.
4. The applicant shall provide the following information alongwith the application for
consideration of the licensing authority.
Manufacturing Details:-
(a) Complete details about the names, addresses of the directors of the company and
addresses of the manufacturing premises and registered offices of the manufacturer.
(b) A brief project highlight indicating the plans of the company, devices to be
manufacture, their viability and other relevant profiles.
(c) Copy of the Site Master File.
(d) A brief description of the manufacturing process of the devices to be manufactured.
(e) Details of the standards followed by the company for Good Manufacturing Practices
and product evaluation.
(f) Name, qualification and experience of technical staff under whose supervision the
devices will be manufactured.
(g) Copies of ISO or any other certifications, if any, obtained by the firm for its
manufacturing facility.
Product Details:-
A. Proprietary/Brand name.
B. Brief description of the device.
C. Category of device.
D. Intended use and method of use.
E. Medical specialty in which the device is used.
F. Qualitative and quantitative particulars of the constituents.
G. Specifications of the materials used.
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H. Testing facilities available in the manufacturing premises for testing.
I. Standards and procedures for testing the device.
J. Contraindications, warnings, precautions potential adverse events and alternate
therapy, wherever applicable.
K. List of accessories and other devices or equipment to be used in combination with
the device. Other descriptive information, including accessories packaged with the
product.
L. Information on stability of the product.
M. Details of clinical trials, (wherever applicable) carried out on the product.
N. Variations in shape, style or size of the device, if applicable.
O. Labeling details conforming to Drugs and Cosmetics Rules, 1945.
P. Physician manual and promotional literature (Literature insert) in English.(if any)
Q. Packaging description including pack sizes.
R. Recommended storage conditions.
S. Summary indications of any reported problems.
5. For the purpose of evaluation of Medical Devices which are new or do not have any
benchmark certification, Expert Committees shall be setup to examine in detail the information
provided by the applicant for the assessment of the device.
6. The committee after completing their assessment forward the opinion regarding suitability of
the device to the competent authority for the purpose of grant of permission for placing the
device in the market.
7. The State Licensing Authority after Joint Inspection and verification would forward the
licence to CLAA for approval.
8. The licence shall be issued in Form 28 of the said Rules after due approval of CLAA.
SALE OF MEDICAL DEVICES IN THE COUNTRY
The importers, stokists and retail sellers of Medical Devices shall obtain appropriate sale licences
from the State Licensing Authorities for these Medical Devices within a period of 3 months form the
issue of these guidelines.