As the representative of the information technology industry, we thank the Ministry of Health and Family Welfare (MoHFW) for this opportunity to present our views and suggestions on the Draft notification to notify all the medical devices under sub-section (b) of section 3 of the Drugs and Cosmetics Act, 1940 to regulate them as per the provisions of the said Act and Medical Devices Rules, 2017 framed thereunder (draft notification).
We appreciate the intent of MoHFW to adopt a new definition of medical devices, which would help align the Indian regulatory regime with the global practices.
NASSCOM organized a policy roundtable on the issue of regulation of medical devices and received feedback from the industry. Based on inputs from our members and other stakeholders, we have prepared our response, which reviews the various aspects of the draft notification along with our comments and suggestions.
- To avoid ambiguity on the standards that are to be met for manufacturing/importing a medical device, the MoHFW should notify the standards for all medical devices after due consultation with the industry. NASSCOM would be happy to organize industry consultations in this regard.
- The standard prescribed should be harmonised with the global practices to facilitate simpler requirements for quality products that are imported.
- Under the US regulation, a manufacturer of a wearable (which tracks certain basic health parameters) who intends to sell it as a medical device can choose to be under the medical device regulation and sell the product after due approval from the regulator. On the contrary, the manufacturer can choose to sell a wearable as a consumer product if there is no intention to sell the product as a medical product. This approach should be adopted in India and the MoHFW should issue a clarification to establish this approach.
- The MoHFW should issue a clarification to establish that standalone software is not covered under the proposed definition of medical devices.
- Though we welcome the move to regulate medical devices by bringing them under the definition of the drug, going forward, the MoHFW should consider enacting a separate law to regulate medical devices.
The detailed submission has been attached with this blog. Please download the attachment.
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