Medical Device Regulations
This article was originally published in RAJ Devices
Executive Summary
Government regulations under development
Government regulations under development
The Indian government is developing regulations to control the supply of domestic and imported medical devices in order to fill the regulatory vacuum that currently exists for high- and medium-risk devices1. The proposal has been developed in order to foster the development of higher-risk medical devices such as biomedical and critical care devices as well as assure the safety and efficacy of those imported from abroad.
The proposal outlines a risk-based regulatory system for high- and medium-risk devices co-ordinated by the centralised administrative office of a newly formed regulatory body, tentatively titled the Indian Medical Devices Regulatory Authority (IMDRA). IMDRA would also comprise a federation of regional offices and would be supported by a string of notified bodies responsible for assessing applications. These would comprise various technical institutes of excellence.
The centralised and regional offices of IMDRA would be collectively responsible for:
- formulating and maintaining a registry of devices and device classifications;
- formulating a list of current standards;
- designating notified bodies;
- interfacing between the manufacturer and scientific experts to facilitate the provision of early advice early in the product development process;
- issuing pre-market and marketing certification;
- surveillance and notification;
- enforcement;
- providing education, interaction, publicity and documentation; and
- post-market follow-up of new products.
Certification requirements
Under the proposed system, high-risk devices such as implants and critical care devices would be subject to approval (Essential certification - CE) by the central office of IMDRA following assessment and QC certification by a notified body. Sponsors of such devices without an equivalent device already on the market would be required to submit safety and efficacy data whereas generic devices may be certified on the basis of a product development protocol (PDP) and equivalence data as well as post-market surveillance. Certification for medium-risk devices such as investigational and non-critical therapeutic devices, would be issued by the regional offices following assessment and QC certification by a notified lab or body, of a PDP and of compliance with voluntary performance standards (Preferred certification - CP). These devices would again be split into two groups, those without a predicate device and generic devices. Radiation emitting devices would remain under the control of the Bhabha Atomic Research Centre (BARC - CP certification) and low-risk devices under the control of the Indian Standards Institute (ISI) and Bureau of Indian Standards (BIS) (CO certification).
Current regulations
Quality assurance is currently employed in India solely for low-risk devices. Sponsors of some low-tech devices such as thermometers and weighing instruments may obtain optional certification from agencies such as the ISI as proof of quality, and the BIS certifies and regulates a few others. The proposed system is intended to implement a regulatory system for medium- and high-risk domestic and imported devices. It has been drafted following a review, sponsored by the Indian Society for Biomedical Technology (SBMT), of the US and EU regulatory systems.
References
1. Certification Procedure for Medical Equipment and Devices: A proposal for establishment of Indian Medical Devices Regulatory Authority (IMDRA), Institute of Nuclear Medicine and Allied Sciences, www.icmr.nic.in