MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Health and Family Welfare)

NOTIFICATION

New Delhi, the 11th February. 2020

S.O. 648(E).— In pursuance of sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby specifies the following devices intended for use in human beings or animals as drugs with effect from the 1st day of April, 2020, namely:—

All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of —

 (i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder:

(ii) diagnosis, monitoring, treatment, alleviation or assistance for any injury or disability;

(iii) investigation, replacement or modification or support of the anatomy or of a physiological process;

(iv) supporting or sustaining life;

(v) disinfection of medical devices and

(vi) control of conception.

 (F.NO. X.11035/281/2018-DRS]

Dr. MANDEEP K. BHANDAIU, IL secy.

The Union Health Ministry notified that all medical devices are now going to be regulated under the Drugs and Cosmetics (D&C) Act, 1940 with effect from April 1, 2020 for effective compliance. Following consultation with Drugs Technical Advisory Board (DTAB), the ministry also notified to amend the Medical Devices Rules, 2017 which may be called the Medical Devices (Amendment) Rules, 2020 and shall come into force on April 1, 2020.

The notification further states, “In the Medical Devices Rules, 2017 (hereinafter to be referred as said Rules), after Chapter III, the following Chapter IIIA shall be inserted, namely-“Chapter IIIA Registration of certain Medical Devices 19a. This Chapter shall be applicable to all devices notified under clause (b) of section 3 of the Act except the medical devices and devices specified in the Eighth Schedule of these rules. The Medical devices referred in sub-rule (1) shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation (CDSCO) for this purpose.”

Additionally, the notification states that any person who imports any medical device referred in rule 19A shall upload the defined information pertaining to the medical device for registration on the “Online System for Medical Devices” established by the CDSCO for this purpose. The importer must upload the name of the company or firm or any other entity importing the medical device and specification and standards of that medical device along with the details of medical device. [Pharma biz]

Response from AIMeD: 

While we manufacturers are okay to be regulated under a Risk Proportionate Medical Devices Rules 2017, we are highly uncomfortable to be regulated under the very rigid and prescriptive Drugs Act as any non-conformity can be treated as a criminal offence by any Drug Inspector at his discretion and hauled before a court and there are no risk proportionate penalties. 

We have been seeking an assurance from MoH&FW that this is a temporary measure until the NITI Aayog-drafted Bill to regulate Devices separately from Drugs becomes a separate Law but no meeting has been called by MoH&FW to address these apprehensions. 

We have additionally sought a response on the following from MoH&FW: 

We seek clear unambiguous statement that 

1- MoH&FW is in sync with NITI Aayog’s proposed Medical Devices Bill and the 2 notifications are only a stop-gap measure till full-blown regulations are available as we can’t accept for Medical Devices to be regulated as Drugs when they are not. 

2- The Medical Devices Rules will be amended for Class A products so as not to cause undue hardships to manufacturers and not disrupt access to low cost medical devices to consumers from SME sector.

3- The MoH&FW will proactively support capacity and capability building of unlicensed but registered manufacturers so that they are able to comply with MDR 17 requirements with ease.

4- Meetings of MD-EAG (Medical Devices Expert Advisory Group) will be called on quarterly basis to ensure a smooth transition for manufacturers and supportive ecosystem and infrastructure availability by regulatory bodies, CAB’s, BIS and QCI.

Rajiv Nath

Forum Coordinator

Dr KK Aggarwal

President CMAAO, HCFI and Past National President IMA