AiMeD Advocates Separate Regulation for Medical Devices as SMTA Loses Legal Battle


Medical Device Industry Calls for Progressive Regulations Amid Legal Disputes

The Association of Indian Medical Device Industry (AiMeD) has reiterated its demand for a distinct regulatory framework for the medical device sector, emphasizing the need for separate regulations apart from pharmaceuticals. This call for action comes in the wake of the Delhi High Court’s dismissal of petitions by the Surgical Manufacturers and Traders Association (SMTA), challenging government notifications that categorized certain medical devices as drugs under the Drugs and Cosmetics Act.


Rajiv Nath, Forum Coordinator of AiMeD, expressed the importance of addressing genuine grievances within the medical device industry to prevent legal disputes. He stressed the role of a separate law, in addition to the Separate Medical Devices Rules 2017, in nurturing the growth of the medical devices sector.

Nath highlighted the recommendations of the Parliamentary Standing Committee on Health and Family Welfare and the National Health Policy 2017, both of which endorse the necessity of a separate regulatory framework for medical devices.

Additionally, AiMeD expressed concerns regarding the Drugs, Medical Devices, and Cosmetics Bill, 2023, and its implications for the domestic medical device industry. The association emphasized the need for comprehensive regulations covering exports, the establishment of a national regulatory authority, and compliance with WHO guidelines.

AiMeD remains optimistic about a potential review of the decision to allow the import of pre-owned medical devices, considering its implications on patient safety and the Make in India initiative.

The association called for a constructive dialogue with policymakers to address concerns and promote progressive regulations tailored to the unique needs of the medical device industry.

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