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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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