Thanks Purvi.
I'm afraid I am still confused. My read of the definition of "medical device" in India is that it continues to be restricted.
In brief, it seems to me that the regulation is only applicable to devices that meet the definition of Rule 2(i) or 2(ii) below, OR are covered by the list of classified medical devices published by CDSCO (http://www.cdsco.nic.in/writereaddata/classdf.pdf). And that the list of classified devices is currently relatively restricted. Please let me know if I have this wrong, and where my error is.
Thanks
Lionel
My logic is as follows:
I note that in the Application section of the regulation (p143) that only those devices meeting the conditions below seem to be under the regulation:
2. Application.- These rules shall be applicable in respect of,-
(i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical
sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under
sub-clause (i);
(ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants
and insecticides notified under sub-clause (ii); and
(iii) devices notified from time to time under sub-clause (iv),
of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940);
which is echoed in the Definition Section on Page 144.
(zb) "medical device" means,-
(A) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical
sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under
sub-clause (i),
(B) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants
and insecticides notified in the Official Gazette under sub-clause (ii),
(C) devices notified from time to time under sub-clause (iv),
of clause (b) of section 3 of the Act;
Explanation: For the purpose of these rules, substances used for in vitro diagnosis shall be referred as in vitro
diagnostic medical device.
Then in Rule 4 "Classification of medical devices".-(p146),the following is outlined:
(3) The Central Licencing Authority shall, classify medical devices referred to in rule 2, based on the intended use of
the device and other parameters specified in the First Schedule.
(4) Based on the classification referred to in sub-rule (3), class wise list of medical devices shall be published on the
website of the Central Drugs Standard Control Organisation:
Provided that the Central Licencing Authority may, from time to time, make additions or deletions in such
list of medical devices or modify the class of any medical device.
And that class wise list appears to be: http://www.cdsco.nic.in/writereaddata/classdf.pdf
This appears to be confirmed in the FAQ published by CDSCO:
http://www.cdsco.nic.in/writereaddata/Latest%20Updated%20%20FAQ%20MDR_2017_14_06_2018.pdf
15. What is the process for classification verification with CDSCO or notified body prior
to submission?
Ø The Central Licensing Authority shall, classify medical devices referred to in Rule 2,
based on their intended use and other parameters specified in the First Schedule.
Based on the classification referred to in sub-rule (3), class wise list of medical
devices shall be published on the website of the Central Drugs Standard Control
Organization (CDSCO): Provided that the Central Licensing Authority may, from time
to time, make additions or deletions in such list of medical devices or modify the
class of any medical device. CDSCO has already displayed the list of medical devices
with classification, which is dynamic in nature.
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Lionel King
Australia
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Original Message:
Sent: 31-Jul-2018 08:44
From: PURVI GORADIA
Subject: India - Medical Device Rules 2017
Hi Lionel,
Your understanding is correct that MD Rules 2017 laid down by CDSCO implements GHTF based classification system.
The MD Classification is explained in details in Medical Device Rule 2017 - GSR 78(E) Dated- 31.01.2017, to download this rule book; below is the link:
http://www.cdsco.nic.in/forms/list.aspx?lid=1580&Id=1
You can scroll to page number 167,wherein the MD classification chapter starts.
The Medical Device Industry in India has already started registering their MD via this portal as the implementation date was January'2018.
If your company is interested in exporting MD to India, the only way out is to register it via online portal and follow MD Rules 2017 as a bible.
Hope this helps !
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PURVI GORADIA
Manager Regulatory Affairs
Mumbai
India
Original Message:
Sent: 29-Jul-2018 20:54
From: Lionel King
Subject: India - Medical Device Rules 2017
I've been looking into medical device market access in India under the new Medical Device Rules, 2017 and am looking for a little clarification:
My current understanding is that, although the new rules introduce a GHTF-based classification system, the devices that the new Rules apply to are restricted to those that:
* have been classified by the Central Licencing Authority (Rule 4 sub-rule (3)),
* which are published as a class wise list of medical devices on the website of the Central Drugs Standard Control Organisation (which should be expected to be updated from time to time). I understand that this is that list: http://www.cdsco.nic.in/writereaddata/classdf.pdf
So: is this correct, or from Jan 1 2018 do the new Rules apply broadly to all medical devices as we might define them in other jurisdictions?
Thanks for your insight.
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Lionel King
Australia
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