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Health Ministry issues draft Medical Devices Rules, 2016
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Ramesh Shankar, Mumbai
June 29 , 2016
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The Union health ministry has issued the draft Medical Devices Rules
which will be applicable in respect of substances covered under
sub-clause (i) of clause (b) of section 3 used for in vitro diagnosis;
substances that are in the nature of mechanical devices covered under
sub-clause (ii) of clause (b) of section 3; and devices specified from
time to time by the Central Government by notification in the Official
Gazette under sub-clause (iv) of clause (b) of section 3 of the Drugs
and Cosmetics Act, 1940 (23 of 1940).
Medical device already
marketed in India prior to the commencement of these rules shall
continue to be marketed as hitherto before subject to the condition that
the manufacturer shall provide evidence of previous sale in India and
apply for license within a period of ninety days from the date the
device is notified under sub-clause (iv) of clause (b) of section 3 of
the Drugs and Cosmetics Act, 1940 (23 of 1940). The Central Government
shall, by notification, specify the date from which medical device
referred in clause (2) shall be regulated in accordance with these
rules.
Medical device already notified under sub-clause (iv) of
clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 and
marketed in India prior to the commencement of these rules shall
continue to be marketed as hitherto before till the expiry of eighteen
months from the commencement of these rules. For the purposes of these
rules, the in vitro diagnostic medical devices which are already
marketed in India and governed under sub-clause (i) of clause (b) of
section 3 of the Drugs and Cosmetics Act, 1940 shall be deemed to be
medical devices and shall also continue to be marketed as hitherto
before till the expiry of eighteen months from the commencement of these
rules.
Under these draft rules, medical devices other than in
vitro diagnostic devices shall be classified as low risk (Class A); low
moderate risk (Class B); moderate high risk (Class C); and high risk
(Class D).
The Drugs Controller General of India shall be the
Central Licensing Authority and shall be the competent authority for
enforcement of these rules in matters relating to import, manufacture of
Class C and Class D medical devices, clinical investigation and
clinical performance evaluation of medical devices and other related
functions, provided that where any manufacturer intends to manufacture
Class C or Class D medical device along with Class A or Class B medical
device, the Central Licensing Authority shall be the competent for
enforcement of these rules and no separate licence from the State
Licensing Authorities shall be required in respect of devices of Class A
or Class B.
The State Drugs Controller, by whatever name called,
shall be the State Licensing Authority and shall be the competent
authority for enforcement of these rules in matters relating to
manufacture of Class A or Class B medical devices, sale, stock, exhibit
or offer for sale of medical devices and other related functions:
Provided that where any person intends to manufacture predicate medical
device, prior approval from the Central Licensing Authority shall be
necessary before applying to the State Licensing Authority.
The ministry has invited objections and suggestions from the stakeholders on the draft rules.
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