Class III Medical Device with CE Mark Approval - India Registration Process

J

jampot

#1
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
:thanx:
 
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A

AG Kumar

#8
Hi

Medical Devices are regulated by Indian Agency fairly, but unlike USFDA in detail. If your organization has approval with MHRA or EU directives' specified notified bodies, it would become pretty easier for you to get registered with Indian FDA.

For your convenience, I am attaching the 'Drugs & Cosmetics Act' and if you refer through pages 535 and 304 & 309, you may get more insight with the requirement.

AG Kumar
 
M

Manojzacharias

#9
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
:thanx:
even though your product doesnt contain any pharmaceutical ingredients, if it is used as packing material you need DMF
DMF type III
 
Last edited by a moderator:
C

ctregoning

#10
Hello,
I have registered in many countries and here is my idea of what they want based on your list:
Plant Master File is probably an example of your device history file. I would also add an example of your Certificate of Conformity and an example of a final test record for the product that they are wanting to distrubute. I would probably attach a letter on company letterhead stating that these are examples of what you can provide with each shipment and have THAT (the letter) notarized.
Drug Master File- You're right- you don't have so a notarized letter stating that.
GMP Certificate: Again, a letter stating that you manufacture to GMPs and notarize that. All these letters can be signed by your Director of Regulatory Affairs.
Free Sales is a Certificate to Foreign Government. India is a signator to the Hague Agreement so you can get your CFG apostilled from the US State Dept.
Power of Attorney: Usually your agent in India would give you a sort of template of what they would like you to say but you are giving the distributor the power of attorney to distribute your products and act on your behalf in doing so. They are requesting authentication of this letter which is kind of strange since they are signators to the Hague Agreement that abolishes the need for "legalization" of documents but you can discuss that with your contact.
In closing, when a rep asks for strange documents, it usually works to use your own good sense in creating these. Remember... don't give away propriatary information. They will try and get it from you. :)
Good luck,
Cherie
 
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