Introduction – Voluntary Registration of Medical Devices in India

The Central Drugs Standard Control Organization (CDSCO) regulates Medical Devices in India. 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 stating the voluntary registration of all Non-Notified Medical Devices over an 18-month period. The 18-month voluntary phase ends on October 1, 2021. This Voluntary registration has no Government Fee at the moment and it is a simple process wherein two main documents – ISO and FSC are needed. This process will generate a file number on the same day of application and is open for a limited time period.  On 21st September, 2021, the CDSCO released a new gazette notification about the Voluntary Registration deadline which is coming up on 30th September, 2021. The latest circular talks about the steps to be followed to obtain a Non-Notified File Number. 

Steps For Voluntary 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 

  1. Login to URL –  https://cdscomdonline.gov.in/NewMedDev/Homepage 
  2. Applicants have to click on the registration link from – https://cdscomdonline.gov.in/NewMedDev/Homepage .
  3. Applicants have to Register a valid Email-id and Mobile No.
  4. After the Validation of Mobile No and Email-id, the applicant has to upload the following documents for registering Non- Notified products on the portal 
  • Id Proof Details  
  • Undertaking  
  • Corporate Address Proof Details (Certificate of Incorporation)  
  • Copy of Manufacturing License and the Wholesale Licenses (If not available, then justification for the same needs to be given)
  1. The applicant has to verify the registration through an OTP received on the  registered Mobile Number.
  2. After self-verification, the applicant can login into the website  and proceed further.

To know the documentation required for registration and importation, Click Here. 

Import License Phase 

The registration of Class A,B,C and D devices has been kept under the voluntary phase for a period of 18 months until 30th September, 2021. Post this voluntary registration period, registration will become mandatory. For Class A & B devices mandatory registration will be followed for 12 months after the 18 months of Voluntary registration period is over (i.e up to 30th September, 2022). From 1st October, 2022, Class A & B devices will fall under the licensing regime. For Class C & D devices mandatory registration will be followed for 24 months after the 18 months of Voluntary registration period is over (i.e from 1st October 2021 to 30th September, 2023). From 1st October, 2023, Class C & D devices will fall under the licensing regime.

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 your products in India. Contact Us to know more


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