Indian Medical Device Rule - January 29th, 2017

[sriramsl]

Hi all
Not sure if anyone has already started a thread on Indian Medical Devices Rule.

On January 29th, 2017 the long awaited Medical Device Rule was released by the Ministry of Health and Family Welfare through the Gazette Notification. I had been a marginal contributor to this rule through AIMED and FICCI.
Currently there are only 16 products are under the notified list and it is expected that 220 products mostly under Class D and Class C are to be notified in another month or two. The effective date of the Rule coming in to force is 1st Jan 2018.

The MDR is attached - the English version (Sorry for some of the highlighting done on the doc)

I am familiar with the MDR, if anyone wishes to get clarification I will be too willing to do so

Regards
Sriram

 

[sreenu927]

Hi Sriram - Thanks for sharing the new MD Rules.
Recently, I have attended a web session regarding the same and during the discussion had some questions/clarifications as below:
The definition of Medical device is still linked back to Drugs as per Drugs and Cosmetics Act.
Including notified medical devices, only 22 types of medical devices are regulated.
Until real-time stability data is available, the approval is only provisional.
Shelf-life of the product should be less than or equal to 60 months (5 years); if more than 5 years, need to contact the Authority.
Batch testing for every lot of product is required.
BIS standards to be followed, if no BIS standards available, then ISO/IEC is accepted.
I don't have the slide deck and did not take notes of all; the discussion was mainly on critical items/issues to consider for manufacturers/importers. Above are only a few of them.

Regards
Sreenu

 

[sriramsl]

Dear Sreenu
Sorry for the late reply
Thanks for your information. There are lot more to the Indian Medical Device rule and it is comprehensive. Yes you are right it is still part of Drugs and Cosmetics Act and controlled by CDSCO with 16 notified products
Within the next few months, 220 more products will be brought under the License rule both for manufacturing and import and sale

I was part of the consulting group for the last 2 years when the rule was framed (as part of AIMED and FICCI member)

If interested I can send a detailed not on this to you

Regards
Sriram

 

[shrutisancheti]

Dear Sreenu
Sorry for the late reply
Thanks for your information. There are lot more to the Indian Medical Device rule and it is comprehensive. Yes you are right it is still part of Drugs and Cosmetics Act and controlled by CDSCO with 16 notified products
Within the next few months, 220 more products will be brought under the License rule both for manufacturing and import and sale

I was part of the consulting group for the last 2 years when the rule was framed (as part of AIMED and FICCI member)

If interested I can send a detailed not on this to you

Regards
Sriram

Hi Sriram,

Can you please provide notes on recently published Indian Medical Devices Rule?

Thank you

 

[somashekar]

If we are a contract manufacturer for Class A / Class B type devices, where we label pack and ship to principle's warehouse directly, how will this new IMDR apply...

 

[sriramsl]

Dear Shruti

Attaching a very brief Notes on IMDR. If you need any further specific details I can provide separately, as it is very comprehensive
Regards
Sriram

 

[sriramsl]

Dear Somashekar,

All manufacturers including contract manufacturers need to get the Manufacturer License from State Licensing Authority for Class A and B products.
However your customer has an option of applying for a Loan License based on the License obtained by your company and sell the products manufactured by your company in his name under the loan license. So the primary license will have to be the ' manufacturer' which is your company in this case
Hope this answers your question
Regards
Sriram

 

[somashekar]

Dear Somashekar,

All manufacturers including contract manufacturers need to get the Manufacturer License from State Licensing Authority for Class A and B products.
However your customer has an option of applying for a Loan License based on the License obtained by your company and sell the products manufactured by your company in his name under the loan license. So the primary license will have to be the ' manufacturer' which is your company in this case
Hope this answers your question
Regards
Sriram

Thank you very much sir ...

 

[somashekar]

Who all are the registered Notified bodies within the IMDR 2017 ..... ?

 

[shrutisancheti]

Dear Shruti

Attaching a very brief Notes on IMDR. If you need any further specific details I can provide separately, as it is very comprehensive
Regards
Sriram

Dear Sir,

Thank you so much for your prompt reply.

Best regards,
Shruti Sancheti