INDIA - GSR 78 (E) - New Medical Device Rules - 2017

mpfizer

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#1
Hi,
can anyone inform us about these new rules GSR 78 (E) , for subcontractor or job worker to a licensed medical device manufacturer in India should the contractor / jobworker also require license or an ISO 13485 certificate is good enough . we cannot find the details in the rules . Firstly we are told that the present law does not allow job worker concept but from 1/1/18 it is allowed but what is the procedure.

Can our Indian friends please help out?

Thanks
Michelle
 
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sriramsl

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#3
Dear Michelle
Please accept my sincere apologies for the delayed response.
In the MDR there is no definition or mention of Sub-Contractor or Job worker or their requirement of getting a license or even ISO 13485. However, as per Fifth Schedule which is similar to ISO 13485:2003, the responsibility and show evidence of control and monitoring of such outsources processes. The clause 1.6 of Fifth Schedule says that the manufacturers of parts or components need to use the clauses as "Guidance" and need not be certified.
In short - No the sub-contractor or Job worker need not get a license, need not have 13485 though preferable
Hope this answers your question
Regards
Sriram
 

mpfizer

Involved In Discussions
#4
Dear Michelle
Please accept my sincere apologies for the delayed response.
In the MDR there is no definition or mention of Sub-Contractor or Job worker or their requirement of getting a license or even ISO 13485. However, as per Fifth Schedule which is similar to ISO 13485:2003, the responsibility and show evidence of control and monitoring of such outsources processes. The clause 1.6 of Fifth Schedule says that the manufacturers of parts or components need to use the clauses as "Guidance" and need not be certified.
In short - No the sub-contractor or Job worker need not get a license, need not have 13485 though preferable
Hope this answers your question
Regards
Sriram
Thanks for your reply.
Does the law as it presently stands today also allow this subcontracting to be allowed for Notified medical devices or will this be allowed only from 1/1/18?

Regards
Michelle
 

sriramsl

Involved In Discussions
#5
This law comes in to effect for the Notified products from 1st Jan 2018. The current rules (CDSCO) applicable for these Notified products does not touch upon this subject at all, for all other products, its free for all now (except for few regulations pertaining to X ray and radiation devices), you can do what you want
 

mpfizer

Involved In Discussions
#6
Dear Michelle
Please accept my sincere apologies for the delayed response.
In the MDR there is no definition or mention of Sub-Contractor or Job worker or their requirement of getting a license or even ISO 13485. However, as per Fifth Schedule which is similar to ISO 13485:2003, the responsibility and show evidence of control and monitoring of such outsources processes. The clause 1.6 of Fifth Schedule says that the manufacturers of parts or components need to use the clauses as "Guidance" and need not be certified.
In short - No the sub-contractor or Job worker need not get a license, need not have 13485 though preferable
Hope this answers your question
Regards
Sriram
Dear Sriram,

Given the difference between the definition of a "Manufacturer" in the Drugs & Cosmetic Act and in EU MDD or MDR would it be possible to allow job workers / outsourcing without a Form 28 Lic.? As per the D&C Act any process or part of process is termed as a manufacture ?

Unless the definition is changed or modified will regulators allow outsourcing ? I doubt.

Views from experts in India would be highly appreciated.

Regards

Michelle
 
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