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Experts discuss issues related to timelines for compliance, guidelines under new Medical Device Rules, 2017
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Shardul Nautiyal, Mumbai
September 18 , 2017
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Even as the Medical Device (MD) Rules, 2017 are set to come into force
with effect from January 1, 2018, industry and legal experts deliberated
on some of the contentious issues related to compliance to guidelines
which have not been finalised as yet and timelines for its effective
compliance.
One such issue is related to the guidelines on
essential principles of safety and performance as stipulated in Rule 6
of MD Rules, 2017, which has not been notified as yet and hence the
concern is that the companies might not have the time to comply with it
as the rules will come into effect in another 3 months time.
Medical
device legal experts R Parthasarathy and Adarsh Ramanujan representing
Lakshmikumaran & Sridharan (L&S) Attorneys discussed the issue
among other relevant points about the timelines to adhere to the new
rules for its effective implementation with 33 pharma companies on the
sidelines of a seminar held in Mumbai recently. The subjects included
post grant compliance, data protection, product recalls and product
liabilities among others.
The MD Rules, 2017 are set out to
regulate all aspects and activities pertaining to medical devices,
namely manufacture of medical devices for sale or distribution, import
of medical devices, labelling of medical devices, conducting clinical
investigation of medical devices, import/ manufacture of medical devices
which do not have a predicate device, registration of laboratories for
carrying out test or evaluation of medical devices, sale of medical
devices, recall of medical devices and export of medical devices.
Part
I of the First Schedule of the MD Rules, 2017 provides the parameters
by which a non-IVD medical device could be classified as Class A / B / C
/ D. Similarly, Part II of the First Schedule of the MD Rules, 2017
provides the parameters by which an IVD medical device could be
classified as Class A / B / C / D. A reading of the parameters laid out
in Part I of the First Schedule of the MD Rules, 2017 suggests that the
risk class of a non-IVD medical device is to be determined by factors
such as the level of invasiveness, the duration of use in the body and
the duration in the body.
Similarly, a reading of Part II of the
First Schedule of the MD Rules, 2017 suggests that the risk class of an
IVD medical device is to be determined primarily by the impact of the
device in the diagnostic process, in addition to its intended use. The
MD Rules, 2017 do not differentiate between non-IVD medical devices and
IVD medical devices in terms of the procedure for obtaining licenses or
approvals or the timelines for obtaining the licenses or approvals. The
difference in compliance requirements under the MD Rules, 2017 exist in
respect of the medical devices falling under different risk classes –
A, B, C, or D. The compliance requirements under the MD Rules, 2017 are
more stringent for Class C & Class D medical devices as compared to
Class A & Class B medical devices. The fee for licenses pertaining
to Class C or Class D medical devices is also higher compared to that
for Class A or Class B medical devices.
A draft list of non-IVD
medical devices and IVD-medical devices along with their risk based
classification was issued by the CDSCO on 29th June 2017. It lists out
462 non-IVD medical devices and 250 IVD medical devices along with their
respective risk class and intended use.
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