The Ministry of Health and Family Welfare (MoHFW) on October 14, issued the Medical Devices (Sixth Amendment) Rules, 2022 to further amend the Medical Devices Rules, 2017.
The following amendments have been stated:
• In rule 19 which specifies ‘Central medical device testing laboratory’, after rule 19F, the following rules have been inserted:
19G. Application of this Chapter. ―
(1) This Chapter shall be applicable to all non-sterile and non-measuring devices classified as Class A medical devices as per the First Schedule (herein in this chapter referred to as Class A non-sterile and non-measuring medical devices).
(2) The medical devices referred to in sub-rule (1) shall be registered through an identified online portal established for the purpose.
19H. Uploading of information for registration.―
(1) The manufacturer of Class A non-sterile and the non-measuring medical device shall upload the information specified in sub-rule (2) relating to that medical device for registration on the Online System for Medical Devices.
(2) The manufacturer shall upload the following in the Online System for Medical Devices, namely:―
(i) name and address of the manufacturing site;
(ii) details of Class A non-sterile and non-measuring medical devices to be provided
(iii) an undertaking from the manufacturer stating that the proposed device is a Class A non-sterile and non-measuring medical device, as per the First Schedule;
(iv) the manufacturer shall self-certify that the product is conforming to the essential principles checklist of safety and performance of such devices;
(v) the manufacturer shall self-certify to comply with the standards specified in these rules; and
(vi) an undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic.
19-I. Registration number. ―
The registration number for a Class A non-sterile and the non-measuring medical device shall be generated after furnishing the information in accordance with rule 19H on the Online System for Medical Devices established for this purpose.
19J. Import of Class A non-sterile and non-measuring medical device.―
(1) Any person who intends to import any Class A non-sterile and the non-measuring medical device shall upload the information in sub-rule (2) relating to that medical device for registration on the Online System for Medical Devices.
(2) The importer shall upload the following in the Online System for Medical Devices, namely: ―
(i) name and address of the importer and the name and address of the manufacturing site;
(ii) details of Class A non-sterile and non-measuring medical devices to be provided:
(iii) an undertaking from the importer stating that the proposed device is a Class A non-sterile and non-measuring medical device, as per the First Schedule;
(iv) the importer shall self-certify that the product is conforming to the essential principles checklist of safety and performance of such devices;
(v) the importer shall self-certify to comply with the standards specified in these rules;
(vi) self-attested copy of the overseas manufacturing site or establishment or plant registration, by whatever name called, in the country of origin issued by the competent authority or Free Sale Certificate issued by the National Regulatory Authority; and
(vii) an undertaking duly signed by the importer stating that the information furnished by the applicant is true and authentic.
19K. Registration number for import. ―
The registration number for import of a class A non-sterile and non-measuring medical device shall be generated after furnishing of the information in accordance with rule 19J on the Online System for Medical Devices established for this purpose.
19L. Maintainance of records. ―
(1) The manufacturer or, as the case may be, the importer shall maintain the records relating to manufacturing or importing along with its sales or distribution.
(2) The manufacturer or, as the case may be, the importer shall produce the records, labels, and instructions for use, on request by Licensing Authorities.
(3) The Licensing Authorities may verify the records and documents referred to in sub-rule (2) at any point in time and investigate quality or safety-related failures or complaints.
19M. Cancellation or suspension of registration.―
(1) The State Licensing Authority or the Central Licensing Authority, as the case may be, may, after giving the registrant an opportunity to show cause as to why such an order should not be passed, by an order in writing stating the reasons thereof, cancel the registration number generated under the provisions of rule 19-I or rule 19K, or suspend it for such period as the Licensing Authority thinks fit, either wholly or in respect of any of the medical devices to which it relates, if in its opinion, the registrant has failed to comply with any of the provisions of the rules under this Chapter;
(2) Any person who is aggrieved by an order passed by the State Licensing Authority or the Central Licensing Authority, as the case may be, may, within forty-five days of the receipt of a copy of such order, prefer an appeal to the State Government or the Central Government, as the case may be, and the State Government or the Central Government, shall after giving the said appellant an opportunity of being heard, confirm, reverse or modify such order.”.
• In the Eighth Schedule, the table has been amended.
These rules will come into force on October 14, 2022.
[Notification No. G.S.R. 777 (E)]
