India CDSCO Alerts Manufacturers to Non-Notified Class C and D Deadline

On October 1st 2023, the India CDSCO will enforce full license requirements for Class C and D non-notified medical devices as the final step of transitioning all medical devices under the new rules. The CDSCO is currently alerting manufacturers/importers to this deadline as the majority of Class C and D medical device manufacturers will be affected, since they were previously exempted from the regulatory requirements.  

Manufacturers must apply for a grant of manufacturing or import license with all the requisite documents and fees outlined in the MDR, 2017 by the October deadline, or face potential market interruption. The import license application process takes at least 6 months so it is imperative to begin the application submission process as soon as possible to meet the October 1st 2023 deadline. 

An application for a grant of manufacturing/import license will be processed proactively by the CDSCO so it can be issued within the stipulated timeframe (prior to October 1st, 2023) in order to avoid any disruption of the supply of medical devices in India. 

If you have questions about the application process for an Import License for Class C and D medical devices from the CDSCO, please contact us here. You can also read more about import license requirements from the CDSCO on our website.  

CDSCO Import License Applications Can Take up to 6 Months

All potential applicants for import of Class C and D non-notified medical devices need to begin application submission as soon as possible in order to complete the submission on time and avoid potential disruption during the importing process.  

This is to avoid similar problems/uncertainty many manufacturers/importers experienced when the Class A and B medical device import license requirements were put in place by the CDSCO for October 1st, 2022. Many manufacturers worried about the status of their import licenses after sending in late applications, which resulted in an extended grace period from the CDSCO for already submitted import license applications.  

More information on the CDSCO’s Class A and B medical device import license requirements can be found on our website. Information on the timeline of implementation for Import Licenses by the CDSCO can be found in the G.S.R. 102 (E) notification from 2022. 

Grow With Us

Please contact us if you have questions about submitting an application for a grant of manufacturing/import license with the CDSCO. Asia Actual specializes in helping medical device manufacturers grow their sales in Asia with experienced, bi-lingual commercial and regulatory experts on the ground in each market. Contact Asia Actual today with any questions or support requests.   

Asia Actual is a regulatory consulting company focused on helping manufacturers grow sales in challenging Asia markets through independent license holding, direct fulfilment, and a variety of sales channel support services.