The Central Drugs Standard Control Organization (CDSCO) of India on January 01, 2024, published the notice for all the stakeholders. The CDSCO established National Single Window System (NSWS) to create a one-stop shop for all investor approvals and to facilitate easy business transactions. It includes approvals/ licenses/ registrations/ clearances as applicable.
On January 1, 2024, the Central Drugs Standard Control Organization (CDSCO) of India published a notice for all stakeholders. CDSCO developed the National Single Window System (NSWS) to facilitate seamless investor approvals and easier business transactions. This includes approvals, licenses, registrations, and clearances as necessary. An NSWS portal has been developed by Invest India through TCS for CDSCO, which will be independent of the existing SUGAM portal or CDSCO Online. Under the Medical Devices Rules, 2017, three activities have been developed and will be made 'Live' on the NSWS portal from January 01, 2024:-
- Form MD-01: Application for Certificate of Registration of Notified Body.
- Form MD-12: Application for Licensure to Manufacture Medical Device for Clinical Research, Testing, Assessment, Inspection, and Training.
- Application for Licence to Import Medical Devices for Clinical Investigations or Test or Evaluation or Demonstration or Training —Form MD-16. In light of the aforementioned, it is asked that all interested parties submit applications for the aforementioned three activities only through the NSWS portal going forward. The cdscomdonline portal will no longer be available for the aforementioned activities as of January 15, 2024.