The Union health ministry has issued a draft notification proposing various amendments in the Medical Devices Rules, 2017, including issuance of registration certificates and manufacturing licenses for certain classes of devices valid in perpetuity subject to conditions.
The amendment also inserted a new Form MD-44 as a format for report of test or evaluation by registered medical devices testing laboratory (MDTL) and to declare the quality of the device.
According to the draft, the Form MD-2 for certificate of registration for a notified body under the MDR, 2017, and Form MD-40 of certificate of registration to MDTL for carrying out test or evaluation of a medical device on behalf of manufacturer are proposed for amendment to include that the registration certificate shall remain valid in perpetuity, unless, it is suspended or cancelled or surrendered, provided that the registration certificate holder deposits a registration retention fee as per the provisions of Medical Devices Rules, 2017.
Form MD-5 for license to manufacture for sale or distribution of Class A (other than non-sterile and non-measuring) or Class B Medical Devices, and Form MD-6 for loan license for these devices, the license shall remain valid in perpetuity, unless it is suspended or cancelled or surrendered, provided that the license holder deposits a license retention fee as per the provisions.
Similar amendment has been proposed in the Form MD-9 for license to manufacture Class C or Class D for sale or distribution, and Form MD-10 for loan license for the same.
The words, registration number in case of Class A (Non-Sterile and Non-Measuring) Medical Devices, is proposed to be added to various rules, in order to facilitate registration of these devices under the rule.
Under Second Schedule regarding various fee prescribed for various processes, the provision for "one overseas site manufacturing Class C or Class D medical device other than in vitro diagnostic medical device", for which the fee prescribed is $3000, has been proposed to be amended as "One overseas site manufacturing Class C or Class D in vitro diagnostic medical device".
The Applicability clause of the Fifth Schedule of the MDR, regarding the quality management system for medical devices and in vitro diagnostic medical devices, will be substituted with the clause "The provisions of this Schedule shall be applicable to manufacturers of Medical devices including In-vitro diagnostic medical devices."
Provisions for details of the sample of medical devices will also be added under various Forms related to receipt for stock of medical devices seized under certain clauses of the Drugs and Cosmetics Act, and the intimation of person from whom sample is taken, among others.
It may be noted that the Ministry has revised the MDR, 2017 in order to include various additions and simplify procedures, as part of regulating the sector, after bringing the medical devices under the purview of the drug regulators.
In October, the Ministry issued a draft amendment to the Medical Device Rules (MDR), 2017, to incorporate the qualifications required for the recruitment of inspectors and government analysts for the medical devices vertical. Last year, the Ministry amended the Medical Devices Rules (MDR), 2017 to assign testing of surgical gloves and medical examination gloves to three medical devices testing laboratories in the country.
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