On January 01, 2024, India’s medical device regulator, Central Drugs Standard Control Organization (CDSCO) issued a notice that applications for certain medical device related regulatory approvals will not be accepted on the current medical devices CDSCO portal (CDSCO MD-Online portal) after January 15, 2024. Instead, they will be accepted through the National Single Window System (NSWS) portal only.
This transition is being implemented in stages. In the first phase, medical device related regulatory applications which are described below in this article will be accepted through NSWS portal. In future all medical device related regulatory applications will be accepted and filed through the NSWS portal only.
What is NSWS portal?
The NSWS portal is a digital platform established by the Indian Government with the aim to act as a single window for all the approvals. The portal enables the investors (manufacturers, importers, traders etc.) to obtain registrations and approvals according to their business requirements.
Which medical devices approvals could have been obtained through NSWS portal prior to January 01, 2024?
Importers and manufacturers of medical devices were previously able to use NSWS portal to make application for legal metrology registration, wireless planning and coordination wing’s (WPC) equipment type approval (ETA), import export code (IEC), etc.
Going forward, which medical devices related regulatory applications will be accepted through NSWS portal only?
From January 15, 2024, the list of medical device applications which will be accepted through NSWS portal are as follows:
- Application for license to import medical devices for the purposes of clinical investigations or test or evaluation or demonstration or training (Form MD-16).
- Application for license to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration, or training (Form MD-12).
- Application for grant of certificate of registration of a Notified Body (Form MD-01).
Is there any guidance for the filing of applications for approvals on NSWS?
There is a user manual for the submission of the applications through the NSWS portal which has been made available by the Indian Government.
What happens to the applications that have been filed before January 01, 2024?
The medical device regulatory applications which were filed before January 01, 2024, through CDSCO MD-Online portal will be processed on the same portal. The medical device regulatory applications that are identified above should not have been filed after January 01, 2024, on CDSCO MD-Online portal. Importers and manufacturers of medical devices will not be able to use CDSCO MD-Online portal for filing regulatory application identified above after January 15, 2024.
Which medical device regulatory applications will be accepted through CDSCO MD-Online portal?
All applications excepting those described above, including applications for import and manufacture of medical devices will be accepted through CDSCO MD-Online portal until further notice.
Conclusion
The transition of certain medical device regulatory applications from CDSCO MD-Online portal to NSWS portal is a welcome development for the importers and manufacturers of medical devices because they will now be able to determine licences/approvals applicable to their business, apply for those approvals and track the status of their applications under one roof i.e. NSWS portal.