Topics In Demand
Notification
New

No notification found.

Blog
NASSCOM’s feedback on MoHFW's ‘Draft notification to notify all the medical devices under sub-section (b) of section 3 of the Drugs and Cosmetics Act, 1940’

November 19, 2019

723

0

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.

NASSCOM Recommendations

  •  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.

In case of any further clarification or suggestion, please write to komal@nasscom.in and jayakumar@nasscom.in


That the contents of third-party articles/blogs published here on the website, and the interpretation of all information in the article/blogs such as data, maps, numbers, opinions etc. displayed in the article/blogs and views or the opinions expressed within the content are solely of the author's; and do not reflect the opinions and beliefs of NASSCOM or its affiliates in any manner. NASSCOM does not take any liability w.r.t. content in any manner and will not be liable in any manner whatsoever for any kind of liability arising out of any act, error or omission. The contents of third-party article/blogs published, are provided solely as convenience; and the presence of these articles/blogs should not, under any circumstances, be considered as an endorsement of the contents by NASSCOM in any manner; and if you chose to access these articles/blogs , you do so at your own risk.


Download Attachment

19561-20191118-mohfw-medicaldevices-nasscom.pdf

images
Komal Gupta
Policy Analyst

Policy Professional| Former Tech and Business Journalist|

© Copyright nasscom. All Rights Reserved.