Medical Devices Rules India 2017
Class B, Class C and Class D: Central License Class A and Class B: The State licensing authority is responsible for registration matters related to these devices. The Authority is responsible for issuing the necessary licences for the import and manufacture of Class C and D products. Companies wishing to manufacture classes C and D as well as classes A and B are eligible to apply. India`s healthcare sector is a fast-growing industry that is expected to reach $280 billion by 2025. The medical device market in India is one of the top 20 medical device markets in the world. It is currently valued at $5.2 billion and is expected to reach $50 billion by 2025. However, India does not manufacture many devices in the country and still imports about 70% of its medical equipment. The manufacture and monitoring of medical devices are highly regulated activities. In India, there were no specific regulations for medical devices and devices were regulated by the Drugs and Cosmetics Act of 1940. To fill this gap, the Central Drug Standard Control Organization has published India`s Medical Devices Rules 2017, which represent the new regulation for medical devices in India. To meet the requirements, they were amended as the Medical Devices (Amendment) Rules 2020, which came into force in April 2020.
These rules cover various aspects of product regulation, including classification, registration, manufacture and import, labelling, sale and post-market requirements, etc. The regulation is a positive step and covers most of the European Union (EU) approval process, which requires devices to be safe and perform their intended function. However, with the rapid advances in medical technology, much is desired to simplify and revise the current regulatory system to harmonize standards to comply with progressive regulations such as the EU. To monitor clinical safety, a PSUR, is required for each medical device to: Medical device classification rules as well as regulatory approval and registration by CDSCO are subject to the control of the Comptroller General of Drugs of India (DCGI). All medical devices in India follow a regulatory framework based on the regulation of drugs of the Drugs and Cosmetics Act (1940) and the Drugs and Cosmetics Rules (1945). Terminological or process comparison between India and the European Union for medical devices/in vitro diagnostic medical devices Like CERs and PERs, some product evaluations and assessment reports mentioned in the EU MDR are required throughout the product lifecycle, but there is no similar reporting requirement or procedure in the RMIM. In addition, for report writing, the IMDR does not provide a structure for these reports, and there has been no link to other guidelines for these reports, creating a gap for the medical device industry in India. However, the IMDR proposes a structure of the PSUR that is absent from the EU guidelines. In the future, the CDSCO will also need to cover these aspects of the IMDR in order to paint a clearer picture and fill the gaps that exist with the current change.
[5.7] To download a copy of the MDR 2017, please click HERE In India, a clinical trial is required for all Class B, C and D medical devices if the product is an investigational device that does not have a predicate product and is manufactured domestically. or if it is a new IVDD. However, a clinical trial is not required to issue the import licence if the product has been marketed in Australia, Canada, Japan, Europe or the United States for at least 2 years and the relevant CLA is satisfied with the available clinical evidence. In such cases, CLA may request a post-marketing study based on the review and recommendation of the Technical Committee. Currently, there are 22 medical devices notified under the Drugs and Cosmetics Act, 1940 and must be registered with CDSCO (India`s regulatory body). Medical devices covered by the new Medical Devices Rules, 2017 are classified by the Global Harmonisation Task Force (GHTF) according to the risks involved, the new EU Medical Device Regulations (MDR)[7] and the In Vitro Diagnostic Medical Devices (IVDR) Regulation 2017[8] make notified bodies, competent authorities and the European Commission more responsible than ever for the safety of medical devices. including in vitro diagnostics. Now, all medical devices must be reassessed for conformity and certification. In the EU, clinical evaluation is the most important step in demonstrating and establishing the safety of medical devices. It is also an important tool for long-term safety assessment and ongoing monitoring of equipment safety. The European Parliament and the Council of the EU recently (23 April 2020) adopted a proposal to extend the transitional period of the MDR by 1 year (26.
May 2021), without delay in the implementation of the IVDR (valid from 26 May 2022). [9] The updated guidelines have much in common with the USFDA guidelines, which are strict with respect to the approval process. While clinical evaluation requirements in India under IMDR are limited to the development phase of certain medical devices only; While post-market requirements are in place, they have their own limitations. Since both policies have been updated, have been effective almost at the same time, and are constantly adapting, this article makes a comparison. The new rules will align regulations on the use of medical devices with international standards to facilitate the manufacture and import of medical devices. The National Medical Device Authority receives approval to promote the local medical device industry, including safety standards, specific price limits, and price control policies for surgical instruments.