Voluntary Registration of Medical Devices in India

Introduction – Voluntary / Non-Notified Registration of Medical Devices in India

The Central Drugs Standard Control Organization (CDSCO) regulates Medical Devices in India under Drugs and Cosmetics Act and Rule, 1940 and 1945 as amended Medical device Rules, 2017 (MDR 2017 – DCGI) and Cosmetic Rules, 2020. Until now, only the Notified Medical Devices have been regulated (there are 37 in this list), mainly focusing on implantable devices. On February 11th, 2020, the CDSCO had published the Medical Device Rules, 2020 as an amendment to the Medical device Rules, 2017 (MDR 2017 – DCGI) stating the voluntary registration of all Non-Notified Medical Devices over an 18-month period. The 18-month voluntary phase ended on October 1, 2021. After the voluntary period, mandatory registration in Form MD-14 for importers to obtain import license in Form MD-15 were required as below,

On 14th October 2022, CDSCO brought in a new amendment, wherein medical devices which are low risk (Class A) non-sterile and non-measuring, will be regulated under the non-notified medical device category of the Medical device Rules, 2017 (MDR 2017 – DCGI) . These products are similar to the EU Class I (self certified) medical devices. These rules are called the Medical Devices (Sixth Amendment) Rules, 2022. This amendment comes under the gazette notification number G.S.R. 777(E).

This non-notified registration of Class A non-sterile and non-measuring has no Government Fee at the moment and it is a simple process wherein two main documents – ISO, FSC, IFU along with simple declarations are needed. This process will generate an automatic registration number on the same day which can be used for clearing the device at the customs.

Steps For Voluntary / Non-Notified Registration of Medical Devices in India

The CDSCO has issued steps and documents required for registration of Non-Notified Medical Devices. These steps are to be followed to apply under the Non-Notified category in India.

SUGAM Registration for the Authorized Indian Agent

ID Proof Details
Undertaking
Corporate Address Proof Details (Certificate of Incorporation)
Copy of Manufacturing License and the Wholesale Drug License in Form 20b and Form 21b/21c (If not available, then justification for the same needs to be given)

Documents to Upload on the SUGAM PORTAL

The importer will have to compile the following documents

Name of the company or firm or any other entity importing the medical device, specification and standards of the particular medical device
Details of medical device to be registered along with their components and accessories
Certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device
Free sale certificate from the CFSC - Country of Origin
Undertaking signed by the manufacturer of the medical device that the proposed device is Class A non-sterile and non-measuring as per the First Schedule of the Medical device Rules, 2017 (MDR 2017 - DCGI) , conforming to the essential principles / GSPR, importer stating that the information provided by the applicant is true and authentic

Conclusion

As per the Medical Device Amendment Rule (MDR 2020) in India, the CDSCO has made it compulsory for all Non-Notified Medical Devices to be Registered which comes into effect from 1st October, 2021. All manufacturers of Non-Notified medical devices are advised to register now as per the stated timelines. Morulaa Healthtech helps manufacturers obtain approval for their products in India. Contact Us to know more