Last Updated on January 9, 2024 by The Health Master
Download notification No. GSR 710(E) dt 20-09-2022, link is given below: The Ministry of health and family welfare (MoHFW) has issued a draft amendment rules to the Medical Devices Rules (MDR), 2017, with provisions to exempt non-sterile, non-measuring Class A medical devices from the licensing regime vide notification No. GSR 710(E) dt 20-09-2022.
The draft comes at a time when the industry has been demanding that low-risk medical devices be exempted from the licensing regime, which is expected to come into force in near future.
The ministry has issued a notification with the draft rules, with a notice that the draft shall be taken into consideration on or after the expiry of a period of seven days from the date on which the copies of the Gazette of India containing the draft rules are made available to the public. The notification was published in the Gazette on September 20, 2022.
The ministry also said that the objections and suggestions, which may be received from any person within the period of seven days, will be considered by the central government.
The Draft Rules add a new Chapter III B to the MDR 2017, with clauses for registration of Class A (non-sterile and non-measuring) medical devices, while amending the eighth schedule to exempt manufacturing and import of these devices under Class A from all provisions of Chapter IV and Chapter V of the MDR, 2017, respectively, subject to the conditions that the manufacturer or the importer shall make registration of such devices as a per the newly added Chapter III B.
Chapter III B is applicable to all non-sterile and non-measuring devices classified as Class A medical devices, and mandates that the medical devices shall be registered through an identified online portal established for the purpose.
Under Rule 19H of the new Chapter, the manufacturer of medical devices shall upload the information specified in the Rules relating to that medical device for registration on the ‘Online System for Medical Devices and the manufacturer shall upload the name and address of the manufacturing site, the generic name of the device, brand name if registered under the Trade Marks Act, 1999, the model number of the product, intended use, the material of construction, dimension (if applicable), and shelf life, if applicable, to the online portal.
It should also give an undertaking that the proposed device is a Class A Medical Device (non-sterile and/or non-measuring), as per the First Schedule of the MDR, 2017.
The manufacturer shall self-certify to comply with the standards prescribed in the Rules.
After furnishing the information as per Rule 19H on the online system for medical devices established for this purpose, a registration number will be generated.
Similarly, the new Chapter also mandates that any person who intends to import any of these non-sterile, non-measuring medical devices shall upload the information for registration on the online system for medical devices.
They will also be offered the registration number once the necessary details are successfully uploaded as per the relevant rules.
The manufacturer and importer shall maintain the records of manufacturing or import along with its sales or distribution and produce the records, labels, and instructions for use, on request by the licensing authorities.
The licensing authorities may verify the records, and documents at any point in time and investigate quality or safety-related failures or complaints.
If the regulator thinks fit, either wholly or in respect of any of the medical devices, it can take action after giving an opportunity to show cause if the registrant has failed to comply with any provisions of rules under this Chapter.
The Ministry has also changed the relevant rules in the MDR, 2017, in tune with the exemption. Class A is considered the lowest in terms of the risk involved in a medical device product.
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