By Stewart Eisenhart, Emergo Group
India's Central Drugs Standard Control Organization (CDSCO) has published new guidance documents covering registration and re-registration of notified medical devices, as well as guidances for manufacturing and import licensing.
Based on an initial analysis by Emergo Group, the medical device registration process in India generally remains the same. However, manufacturers should bear in mind several small changes.
- Medical device generic and model names as well as shelf life information must now be included on Power of Attorney documents; existing licenses will require amendments or endorsements before new models can be imported to India.
- All certificates submitted to the Drugs Controller General of India (DCGI) should be valid for at least six months following their submission.
- Certificates must specify legal and manufacturing site names and addresses along with product names, generic names and model names as necessary.
- Re-registration requirements are now the same as those for registrations of new devices; copies of Form 41 must be submitted along with applications for re-registration.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.