Permission To Import/Manufacture Medical Device Without Predicate Device

Permission To Import/Manufacture Medical Device Without Predicate Device

For importing/manufacturing a medical device which does not have a predicate or similar medical device in the Indian market. An application using form MD-26 has to be filed at the Central Licensing Authority. The permission whereby is granted in form MD-27.


The application can be filed for either importing such a device or for manufacturing such a device(s) in India. If the applicant is a foreign company, the application has to be filed through an authorized Indian agent, such as CliniExperts.

Anyways, seeking permission to import/manufacture such medical devices is a tedious and hectic process. A lot of paperwork and formalities have to be undertaken. Inherently, hiring an expert is the most logical option in such cases.


At CliniExperts, we help companies obtain import/manufacturing permission for medical devices which do not have a predicate device in the Indian market.


The normal application process takes a long time as the applicants are unaware about the proper format and essential inclusive information of the documents to be submitted. However, we have the right experts and resources to get this done easily and quickly.


For more information on the same or any query, please feel free to reach us at or +91-767 20 05 050


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