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. Understanding the Medical device registration process in India is crucial for compliance. 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, and CDSCO medical device regulatory compliance is key during this process.
- For Class A and B devices, from October 1, 2021, to September 30, 2022 (extended to 31st March 2023)
- For Class C and D devices, from October 1, 2021, to September 30, 2023 (extended to 31st March 2024)
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). Understanding the Documents required for medical device registration is essential to comply with these regulations. 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. The Documents required for medical device registration include ISO, FSC, IFU along with simple declarations are needed. This streamlined Medical device registration process in India generates 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 to ensure CDSCO medical device regulatory compliance. These steps are to be followed to apply under the Non-Notified category in India.
SUGAM Registration for the Authorized Indian Agent
- Login to URL - Click Here
- Applicants have to click on the registration link - Click Here
- Applicants have to Register a valid Email-ID and Mobile No.
- After the Validation of Mobile No and Email-id, the applicant has to upload the following documents for registering Non- Notified products on the SUGAM portal
- 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)
- The applicant has to verify the registration through an OTP received on the registered Mobile Number.
- After self-verification, the applicant can login into the website and proceed further.
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 devices to be registered along with their components and accessories must be provided, particularly for those applying under Voluntary registration non-notified medical devices.
- 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 to ensure they can also obtain a medical device import license in India. Morulaa Healthtech helps manufacturers obtain approval for their products in India, including guidance on voluntary registration of non-notified medical devices. Contact Us to know more