DTAB Recommends Various Amendments In Medical Devices Rules, 2017

New Delhi: The Drugs Technical Advisory Board (DTAB) has recommended various amendments to the Medical Devices Rules (MDR), 2017, for inclusion of disinfectants under the definition and applicability clauses and to bring in changes for quality management rules in line with the updated ISO standards for the devices.

One of the recommendations is to amend the definition and applicability clause of the MDR for inclusion of disinfectants. The proposal is to amend the definition in Clause (ii) of Rule 2 and Clause (ii) of Rule 3(zb) in the MDR, to this effect, as suggested in the 79th DTAB meeting held on May 16, 2018.

According to this recommendation, the amendment is proposed to substitute the words “substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii”, with “disinfectants that are used to pre-clean or decontaminate medical devices prior/after to patient use and substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), notified under sub-clause (ii)”.

Further, the Board also recommended allied amendments in the preamble/scope in the rules.

Another proposal considered and agreed in the latest DTAB meeting is to amend the Schedule V (Quality Management System for medical devices and In-Vitro diagnostic medical devices) of the MDR, in line with the ISO 13485:2016.

The Fifth Schedule of MDR, 2017 deals with the quality management system of medical devices and in-vitro medical devices and it is largely based on requirements of ISO 13485:2003. These provisions have been updated by ISO in its third edition, which is effective from March 1, 2019 and this has called for an amendment in the Fifth Schedule, observed the Board.

The matter was also discussed in the 55th Drugs Consultative Committee (DCC) meeting, which recommended the regulator to prepare the necessary provisions or guidelines for the same. Following this, the DTAB, in its 82nd meeting held on April 2, 2019, agreed with the proposal and recommended amendment of the Fifth schedule to incorporate necessary provisions.

In its 90th meeting held on January 25, 2024, the DTAB once again apprised about the details on these proposals and agreed for the proposal.

The Board’s latest meeting was considering these proposals once again, as it was deliberating on certain proposals for which it had already shared recommendations to the concerned ministry for taking actions including publication of draft rules.

The Ministry informed the Board that since several important notifications for amendments of rules under the Drugs and Cosmetics Act, 1940 have been issued after these recommendations, the DTAB recommendations may be critically reviewed and revised in the context of the updated rules and recent notifications.

Considering a proposal to amend the MDR, 2017 in a manner when medical devices which already exist in the Indian market for use are brought in future under regulation, such devices shall not be a new medical devices, the latest Board meeting recommended that the list of such old devices may be prepared and to be placed before the Board for further deliberation.

Another proposal considered in the 83rd meeting of the Board, to amend the Form MD-11 under the MDR, 2017, to exclude the condition that the audit or inspection book shall be stamped by the Central Licensing Authority/State Licensing Authority. However, it will have a mandate that the Form should be with seal or stamp by licensing authority, without specifying whether it is the Central or the State authority. Form MD-11 is part of Rule 26, under which the license holder shall maintain an audit or inspection book to enable the notified body or medical device officer to record his observations and non-conformity, if any.

However, DTAB refused to agree with some of the proposals from the previous meetings, including addition of provisions in the MDR, 2017 for waiver of evaluation for In-Vitro Devices, in-line with waiver given for medical devices regarding permission to import or manufacture devices which does not have any predicate devices. It also did not agree to another proposal to amend the Rules to allow audit of the manufacturing site of Class B devices after grant of the license to manufacture, as in case of Class A Medical Devices.

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