A Review of New Medical Device Rule in Indian Healthcare

The Healthcare sector in India has undergone significant upgrades in the 21st century.

Medical devices have emerged as a key aspect in the healthcare sector of any developing healthcare-sensitive nation. The medical devices market in India is one of the top 20 medical device markets in the world.

These are used for various functions in the field of healthcare but are not limited to, screening and diagnosis, treatment/care, restoration, and monitoring. India does not manufacture many devices indigenously and still imports medical devices.

The Union government has notified the Medical Devices Rules as Medical Devices (Amendment) Rules, 2022. A new medical device rule which came into force has finally given the medical device industry a distinctive regulatory identity. The multitude of devices used in the country today from the humble to the complex has the potential to come under the ambit of rules to ensure patient safety, quality, and performance parameters of devices sold within the country. The main goal of this legislation is to bridge the accessibility and affordability gap.

These rules cover various aspects of device-related regulations, including classification, registration, manufacturing, import, labeling, sales, post-market requirements, etc.

Based on the intended use of the device, the risk associated with the device, and other parameters referred to in IMDR, the Central Licensing Authority (CLA) of India classifies Medical Devices and IVDMDs into four risk classes.

  1. Low risk-Class A
  2. Low moderate risk-Class B
  3. Moderate high risk-Class C
  4. High risk-Class D.

Medical devices categorized under IMDR need to undergo only two-phase studies, i.e., pilot (exploratory study) and (pivotal study) clinical investigations, unlike four-phase studies required. For a clinical investigation or clinical performance evaluation, a clinical investigation report or a clinical performance evaluation report, respectively, is required to be provided to the ethics committee, participating investigators, and the CLA for a completed or prematurely terminated the study.

Several manufacturers are awaiting audits from the government licensing authorities. Online registration with self-declaration would make this transition process easier.

The manufacturer will have to self-certify that the product is conforming to the essential principles checklist of safety and performance of such devices, the government said in the notification. It added that the manufacturer shall self-certify to comply with the standards prescribed in the Medical Devices Rules, 2017. After furnishing the information on the “Online System for Medical Devices” established for the purpose, the registration number will be generated.

In the case of an importer of medical devices, the importer will upload the name and address of the importer and the manufacturing site together with details of the medical devices. The importer, too, will have to give an undertaking stating that the proposed device is a class a medical device, and it conforms to essential principles of safety.

The manufacturer or importer is required to maintain records of manufacturing, import sales, and distribution. They would have to produce such records upon request by the licensing authorities, the notification said.

To monitor clinical safety, a PSUR for each medical device is required to:

a. Report all the relevant new information from appropriate sources

b. Relate these data to patient exposure

c. Summarise the market authorization status in different countries and any significant variations related to safety; and

d. Indicate whether changes will be made to product information to optimize the use of the product.

The state or central licensing authority may cancel the registration number or suspend it if the manufacturer or importer fails to comply with these rules.

In conclusion

As medical devices deal with the health and safety of the patients, their manufacturing is done in a strictly regulated environment, and they fulfill stringent regulatory requirements and guidelines. While the drug regulations in India are well established for decades, a well-defined regulation for medical devices was missing for a long. Nevertheless, the Indian regulatory regime for medical devices has recently been very active and has developed structured regulations for medical devices.

India has progressed multi-folds in the healthcare and medical devices sectors in the last few years. With the execution of medical device legislation, India has paved a new path in the field of medical devices.

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