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Indian Medical Device Rule - January 29th, 2017
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Indian Medical Device Rule - January 29th, 2017
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2017, india, indian health ministry, medical device standards and regulations, medical devices
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  Post Number #1  
Old 31st March 2017, 05:04 AM
sriramsl

 
 
Total Posts: 38
Look! Indian Medical Device Rule - January 29th, 2017

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
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf Medical Device Rule 31st Jan 2017 English Ver.pdf (1.29 MB, 65 views)
Thank You to sriramsl for your informative Post and/or Attachment!

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  Post Number #2  
Old 10th April 2017, 05:25 AM
sreenu927

 
 
Total Posts: 541
Re: Indian Medical Device Rule - January 29th, 2017

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
Thank You to sreenu927 for your informative Post and/or Attachment!
  Post Number #3  
Old 17th April 2017, 01:04 PM
sriramsl

 
 
Total Posts: 38
Re: Indian Medical Device Rule - January 29th, 2017

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
Thanks to sriramsl for your informative Post and/or Attachment!
  Post Number #4  
Old 22nd April 2017, 01:21 AM
shrutisancheti

 
 
Total Posts: 8
Re: Indian Medical Device Rule - January 29th, 2017

Quote:
In Reply to Parent Post by sriramsl View Post

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
  Post Number #5  
Old 22nd April 2017, 02:56 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,364
Re: Indian Medical Device Rule - January 29th, 2017

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...
  Post Number #6  
Old 22nd April 2017, 06:02 AM
sriramsl

 
 
Total Posts: 38
Re: Indian Medical Device Rule - January 29th, 2017

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
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: docx Notes on Draft Medical Device Rules2.docx (28.5 KB, 39 views)
Thank You to sriramsl for your informative Post and/or Attachment!
  Post Number #7  
Old 22nd April 2017, 06:13 AM
sriramsl

 
 
Total Posts: 38
Re: Indian Medical Device Rule - January 29th, 2017

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
Thanks to sriramsl for your informative Post and/or Attachment!
  Post Number #8  
Old 23rd April 2017, 11:46 PM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,364
Re: Indian Medical Device Rule - January 29th, 2017

Quote:
In Reply to Parent Post by sriramsl View Post

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 ...
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