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Indian Medical Device Rule - January 29th, 2017

somashekar

Staff member
Super Moderator
#11
Hi Sriram.
If my understanding is correct, anyone of the registered notified body will be allotted to carry out the audit of the manufacturing site. A fee as fixed by the central or state department will be charged by the notified body payable by the client.
Why is the industry not having a choice here. I would always prefer my ISO 13485 CB to be our notified body (I know they will be registering)
With one more audit here, the ISO 13485 is losing credibility, just as the 2016 version is coming up for implemenrtation.
 

sriramsl

Involved In Discussions
#12
For IMDR and for ICMED 13485, NABCB is the competent authority for NB certification. Currently Intertek, TUV have been accredited as NB for both and 4 other NBs are under process including UL, SGS, BSI.
Are you aware of ICMED 13485, which is issued by QCI which is the parent body of NABCB. ICMED 13485 is the QMS system based on ISO 13485:2003 + 21 more items primarily from the perspective of Essential Requirements of Med devices, that are incorporated in to ICMED 13485. By getting ICMED 13485 certification, the company will get both ICMED 13485 and ISO 13485. But it has not harmonised the 2016 version.

Many Indian companies particularly the MNCs are opposed to this move by QCI due to their own vested interests, it is currently voluntary.

QCI is also planning to come out with ICMED 13485 Plus - which will be the standard for ICMED marking (equivalent to CE marking).

Both the IMDR and ICMED will become complimentary to each other in future

Regards
Sriram
 
#13
Hi Sriram,

Many thanks for your useful email on Indian new MDR. Can you please let know if this is officially published in cdsco website or pls send me the official link.



Thank you
Antonio
 

sriramsl

Involved In Discussions
#14
Dear Antonio
The web link in cdsco is http://www.cdsco.nic.in/forms/list.aspx?lid=2057&Id=31
Please click on the gazette notification January 31 2017 GSR 78(E)

This was notified on Jan 31st in the Central Government Gazette. I had earlier attached only the English version in my original posting in this thread.

Though the whole scheme is currently in the purview of CDSCO under Drugs and Cosmetics Act, it will be eventually moved from CDSCO to QCI which will be named as the competent authority.

Regards
Sriram
 

sriramsl

Involved In Discussions
#15
Hi Sriram.
If my understanding is correct, anyone of the registered notified body will be allotted to carry out the audit of the manufacturing site. A fee as fixed by the central or state department will be charged by the notified body payable by the client.
Why is the industry not having a choice here. I would always prefer my ISO 13485 CB to be our notified body (I know they will be registering)
With one more audit here, the ISO 13485 is losing credibility, just as the 2016 version is coming up for implemenrtation.
Dear Somashekar
There had been a lot of debate on this issue raised by the companies as well as NBs/CBs - the stand taken by the government is that initially there has to be a distribution of the clients for NB/CB so that the services are not affected with respect to the time line given in the rule itself, if it is skewed in favour of few NBs. Moreover there are lot of spurious CB/NBs who certify companies with payment of certain fees irrespective if those companies really have 13485 implemented. I have seen many certificates of companies and they are all bogus. Government wants to control these. This clause will get relaxed and the clients will be able to choose their NB/CBs once things have stabilised.

Moreover, the Government will fix the charges that a NB can charge to a client, which was heavily opposed by the NBs, but Government put its foot down and wanted all the manufacturers to comply and make it more affordable.

On 13485:2016 - The whole IMDR formulation had been going on for the last 2 years vigorously and at that time 2003 was applicable and hence incorporated. The message from QCI is that the rule will harmonize 2016 in Jan 2019 by when it becomes mandatory internationally, also there is ICMED 13485 plus coming up.

Yes, for the first 2 to 3 years there will be lot of churning and it should stabilise and get harmonised with international standard by then.

The IMDR is in line with the WHO guideline which is based on GHTF, while WHO recommended 2 stage implementation, India is going ahead with single full throttle implementation

Regards
Sriram
 
#16
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
Hi Sriram,

Could you kindly advise on the below queries;pls?


Has any Notified Body been approved by CDSCO as of today?

Can the MDR be effective if it does not get ratified by the Parliament before the scheduled date; ie 1st Jan 2018

Can Voluminous Documents like Device Master File, Site Master File etc be submitted in the portal itself or their hard copy to be submitted with the Licencing authority ?

Many thanks in advance
Darly
 

noorain

Starting to get Involved
#17
I didn't see ambulatory ECG or ECG devices as such mentioned in the list. I'm not sure now if im looking at the right list. can some one please share the list. Also if the MDis not in list what is the process?
 

sriramsl

Involved In Discussions
#18
Dear Noorain
As of now only 15 devices are listed and they are all Class D devices, most of them are Catheters and the like.
We expect the list to be expanded to all the remaining Class D and Class C devices only by middle of 2018 with 6 months period for compliance.
So as of now ECG devices are not in the list
Sriram
 
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