Jan 2, 2024

Central Drugs Standard Control Organization, Government of India has announced that w.e.f 01.01.2024 online applications for some of the registration/ licensure activities shall now be made through NSWS portal i.e. www.nsws.gov.in. Accordingly, all stakeholders shall henceforth apply through NSWS portal. The activities that will be applied through NSWS portal are:

  1. Application for grant of Certificate of Registration of a No1ified Body-Form MD-01.
  2. Application for License to manufacture medical device for purpose of clinical investigations, test, evaluation, examination, demonstration or training—Form MD-12.
  3. Application for License to Import Medical Devices for the Purposes of Clinical Investigations or Test or Evaluation or Demonstration or Training —Form MD-16.

User guide for the same has also been issued which can be referred to here.

Earlier, the above applications were made through SUGAM portal for medical devices i.e. www.cdscomdonline.gov.in. This portal shall be disabled for above activities w.e.f. 15.01.2024.

For the unversed, National Single Window System (NSWS) is established by the Central Government of India, with the objective to build a genuine Single Window System which act as a one-stop shop for all the approvals required by the investor and facilitates ease of doing business. The scope of NSWS includes all the approvals/licenses/registrations/clearances as applicable. This portal will be independent from the existing CDSCO portals i.e. www.cdscoonline.gov.in and www.cdscomdonline.gov.in.

Reference: CDSCO public notice