Our company manufacture a Class III medical device with CE mark approval.
We have been approached by a distributor from India who would like to sell our device in India. Our contact has provided a list of documents that they indicate are necessary to Register the product and company in India
1) Plant Master File Duly Notarized
2) Drug Master File Duly Notarized
3) WHO,GMP Certified Duly Notarized
4) Free Sale certificate the country of origin
5) Power of Attorney duly notarized and authenticated fom the INDIAN EMBASSY the country of origin.
As our product is a synthetic device with no pharmaceutical components I don't believe a Drug Master File is necessary, furthermore we do not possess a GMP certificate.
It would be appreciated if anyone who has recently been through the registration process in India could offer advice and interpretation of the terms used above.
For example is a Plant Master File the same as our Device History Record ?
Many thanks in advance