Date: 18.11.2019

To,

The Under Secretary (Drug Regulation),

Ministry of Health and Family Welfare, Government of India,

Room No. 414 A, D Wing, Nirman Bhavan, 

New Delhi – 110011

Email drugsdiv-mohfw@gov.in

Subject:  Comments on Draft Notification # GSR 797 (E) dated 18^th October, 2019

Dear Sir,

The subject Draft Notification # GSR 797 (E) dated 18th October, 2019 has been reviewed by the Heart Care Foundation of India (HCFI). The comments of HCFI on the Notification are as follows:

1)    Medical Devices should be regulated under a Separate Law eventually and not as a Drug beyond 5 years, nor as amendment to Drugs Act.

2)    It should be specifically mentioned in the new notification that the present notification is only temporary transient mechanism till the separate Medical Device Law is legislated.

3)    A New Medical Device National Regulatory Authority may be made under the Medical Device Law under MOH&FW (like FSSAI) OR by a revamped CDSCO as a National Healthcare Product Regulatory Authority with Medical Device Division, separate from Drugs Division.

4)    Even in other countries there is a separate legislation for Medical devices. Few examples are as follows:

1. In US, Medical Devicesare regulated by FDA- Centre for Devices & Radiological Health. FDAs Centre for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, re-label, and/or import medical devices sold in the United States.
2. In EUthey are regulated by European Medical Agency,

In EU, there is decentralized procedure of marketing authorization as no single body regulates Medical devices. A system of third party compliance is followed. Notified Bodies are the third party that issue Quality Assurance certificates and ensures post approval compliance to Quality Management System (QMS). Medical Devices are regulated by Medical Devices Directive, which consists of three directives that regulate the safety and marketing of medical devices in Europe. The three directives are:

• Medical Device Directive (MDD 93/42/EEC),
• Active Implantable Medical Device Directive (AIMDD 90/42/EE),
• In vitroDiagnostic Medical Device Directive (IVDMDD 98/79/ EC).

In view of the above, HCFI humbly requests your goodself to issue a new notification, thereby stating that a new and separate legislation shall be enacted for regulation of Medical Devices in India and the medical devices will not fall under the purview of Drugs and Cosmetics Act and Rules.

Kindly do the needful

Thanking You

Yours faithfully

Dr KK Aggarwal President HCFI and CMAAO

Dr K K Kalra: Advisor HCFI

Ms Meenakshi Datta Ghosh, Vice Chair HCFI Round Table on Health and Wellness