Decoding The Medical Devices Rules 2017 Along With 2020 Amendment And Risk Based Classification Of Medical Devices
Dec 04, 2020.By: Ayush Anand, Partner, Atharva Legal;
Dr. Shailesh Singh, Expert - Pharmaceutical Regulatory Consultant; and
Chakradhar Reddy, Research Associate, Atharva Legal
Introduction
Before the introduction of the medical devices rules, 2017 there was no legislation specifically dealing with the regulation of medical devices. The Drugs and Cosmetics Act, 1940 was not well equipped to handle the needs of a 21st-century health industry which is witnessing a rapid innovation in medical technology. The rules were introduced keeping in mind the need to empower and assist the domestic manufacturing industry which aspires to be a global provider of healthcare devices and technology. The rules also provide systemic rules for importers and distributors of medical devices in India. Medical devices, substantial equivalence, investigational medical device, predicate device, new in vitro diagnostic, clinical investigation and various other key terms have been well defined in the rules. This amendment comes in the line of adapting to GHTF principles of classification of medical devices.
Some of the Key notable features of the Medical devices rules, 2017:
The standard operating procedure regarding Manufacture of medical device for sale or distribution is different for Class A and B compared to Class C and D medical devices. For devices belonging to category A and B, the application would be through an online portal of Health Ministry while for C and D the application shall be made through a central government portal to CLA. There is no requirement of an audit for class A devices before grant of a license. 120 days from the issue of license is the timeframe within which an audit could be conducted. While there is a necessity to conduct an audit for Class B device before granting manufacturing license an audit will be carried out within a period of 90 days.
The application for medical devices belonging to class C and D shall be made through online portal of the Central Government to CLA (Central Licensing authority), which can carry out an inspection within a period of 60 days from the date of application. There shall also be no inspection of any manufacturing site for loan license which is already licensed to manufacture medical devices. After completion of inspection, the inspection team shall forward the report to CLA through online portal.
2020 Amendment:
Two notifications were issued by the Ministry of Health and Family Welfare in the Indian Gazette in the month of February 2020, Medical Devices Rules, 2017 has been amended and The Medical Devices (Amendment) Rules, 2020 has been brought into effect from April 1, 2020. A new definition for medical devices has also been issued.
Registration of devices:
October 1, 2021 is the deadline for manufacturers and importers of various medical devices to be compulsorily registered with the Drug Controller General of India. Also, the applications will be accepted through an online portal called ‘Online System for Medical Devices’ which has been established by Central Drugs Standard Control Organization (CDSCO) from April 2020 or whenever the online portal is ready to accept applications. Failure to register before the deadline of October 1st 2021 will lead to an importer or manufacturer not being able to sell or distribute or market its devices in India.
Timeline and Classification:
April 1st, 2020 to October 1st, 2021:- Voluntary registration will be required to manufacture, import, distribute or sell Newly Notified Medical Devices.
From October 1st, 2021:- Mandatory registration will be required to import, manufacture, distribute or sell such medical devices.
Before August 11, 2022:- License will be required to manufacture, import, distribute or sell Class A (low risk) or Class B (medium risk) medical devices.
Before August 11, 2023:- License will be required to manufacture, import, distribute or sell Class C (moderate high risk) and Class D (high risk) medical devices as well.
Non-Compliance with the rules:-
Manufacturing or selling of the medical devices without a valid license will lead to imprisonment for not less than three years, extendable up to five years and fine which shall not be less than Rs 1 Lakh or three times the value of drug confiscated,
The CLA has authority to verify the registration documents and license at anytime and investigate quality and safety related failure or complaint. While a show cause notice would be served in case of any failure to comply with the present rule as to provide an opportunity to explain why the registration should not be cancelled, the CLA has authority to cancel the registration if it thinks the explanation is non-satisfactoryor is unreasonable. It can suspend devices or the whole manufacturing as it thinks fit.
Exemption:
All 37 categories of medical devices which were regulated or notified before Feb 11th, 2020 via the Medical devices rules, amendment shall not be required to obtain a registration and are exempted. But they are still subject to other compliances under MDR rules.
What it means to Manufacturers, importers and Consumers:
For Manufacturers and importers, the new amendment gives a much-nuanced set of rules containing a timeline for registering and licensing medical devices based on risk classification. With immediate effect, the importers are required to display the registration number on the label of the device. Even the marketers and others who are part of the supply chain shall be required to obtain a license for distribution or sale. For customers, the new rules will ensure that they get medical devices which are quality assured and are at par with the international standards. With all newly notified medical devices needing ISO-13485 certification for registration, the move will define the industry standards that the manufacturers need to follow to ensure quality management standards are met. DCGI has the right to suspend or cancel the registration if such standards are not met.
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