Cover Story

Updates on Medical Device Regulations in India & Key Features Of Roadmap Ahead

Export

• As per the notification G.S.R.318 (E) dated 18.04.2019, the FSC for class A and B shall be issued by SLA and for Class C and D by CLA with the fees as per category and not for distinct device (Rs.1000 per category as per Second Schedule).

• The labels on packages of devices for export shall be adopted to meet the specific requirements of the importing country. If consignee does not want to label the name and address of manufacturer then code number or special code number should be mentioned as per the approval of CLA.

Medical Devices Roadmap in India

• Many of the Medical Devices like equipments, analyzers, instruments etc. used in various healthcare facilities for diagnosis, treatment, mitigation are currently out of scope of regulation under Drugs and Cosmetics Act. Concerns have been raised from time to time in different fora regarding safety, quality and performance of non notified medical devices.

• Comprehensive regulation of Medical Devices is important for ensuring safety and well beings of patient’s using such Medical Devices.

• Keeping in view the need for such comprehensive regulation of all medical devices, Ministry of Health and Family welfare, had constituted a committee vide order No.11035/61/2019-DR dated 04.02.2019 to work out a roadmap on regulation of all Medical Devices.

Terms of References (TORs) of the committee

• To work out a roadmap for notification of all Medical Devices under the Drugs &Cosmetics Act, 1940.

• To work out a roadmap for Medical Devices vertical in CDSCO.

Key features of Roadmap

• Inclusion of Medical device definition “All Medical Devices including an instrument, appara tus, 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 assisted in its intended function by such means for one or more of the specific purposes of,

a) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
b) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
c) Investigation, replacement or modification or support of the anatomy or of a physiological process;
d) supporting or sustaining life;
e) disinfection of Medical Devices;
f) control of conception;’’

 

First Phase	Second Phase	Third Phase
Issue of notification for including all medical devices by their technical definition and provisions for exemptions to obtain import / manufacturing license and permission for clinical investigation till 30 month (class A and B) and 42 month (class C and D). Registration of all non-regulated Medical Devices on SUGAM portal i.e. obtaining voluntary registration (in the form of registration number) up to 18 months from date of notification. Thereafter compulsory registration for 12 months (class A and B) and for 24 months (class C and D).	Registration (by number) of Class A & B devices shall be followed by mandatory licensing within 12 months after 18 months of voluntary registration period. After 12 months period, no person, company, organization should be allowed to manufacture, import, sale or distribute Class A & Class B Medical Devices without prior license under the Medical Devices Rules, 2017.	Registration (by number) of Class C & D devices shall be followed by mandatory licensing within 24 months after 18 months of voluntary registration. After the 24 months period, no person, company, organization should be allowed to manufacture, import, sale or distribute Class C & Class D Medical Devices without prior license under the Medical Devices Rules, 2017.

Separate Vertical for Medical Device

754 posts of

• Regulatory

• Laboratory and

• Medical specialist

Officials in various disciplines of medical devices are proposed for recruitment and are under active consideration for incorporation at advanced stage as per procedures.

Action Plan

• MDTAG (Medical Devices Technical Advisory Board) has been constituted including experts from various Govt. Departments & various Associations in order to discuss the various issues/concerns related to medical devices and In Vitro Diagnostics Kits.

• As per the request of various manufacturers the issue related to put the old license no. and old name on the label for export purpose and during transition period as per choice of applicant was deliberated in DTAB and is under consideration for adoption.