Govt to exempt non-sterile, non-measuring Class A medical devices from licensing regime

This came following draft of certain rules further to amend the Medical Device Rules, 2017, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is published for information of all persons likely to be affected thereby and notice is given that the said draft rules shall be taken into consideration on or after the expiry of a period of seven days from the date on which copies of the Gazette of India containing these draft rules are made available to public.

According to the proposed rules, in the Medical Devices Rules, 2017, Chapter IIIB, which deals with the registration of Class A (non-sterile and/or non-measuring) medical devices, will be added to the Medical Devices Rules, 2017 after Chapter IIIA.

The Draft Rules further amend the Eighth schedule to exempt the manufacture and import of Class A (non-sterile and non-measuring) medical devices from all provisions of Chapter IV and Chapter V of the MDR, 2017, respectively, and add a new Chapter III B with registration provisions to the MDR, 2017.

This exemption is subject to the condition that the manufacturer or importer register such devices in accordance with the newly added Chapter III B.

"The manufacturer of a 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", the draft rules said.

According to Rule 19H of the new Chapter, the manufacturer of a medical device must upload the information specified in the Rules relating to that medical device for registration on the "Online System for Medical Devices."

As per the proposed draft rules, the manufacture shall upload:

(i) The name and address of the manufacturing site.

(ii) Details of Medical devices

a) Generic name

b) Brand Name (if registered under the Trade Marks Act,1999)

c) Model No (if any)

d) Intended use

e) Material of construction

f) Dimension (if applicable)

g) Shelf life (if applicable)

(iii) An undertaking from the manufacturer stating that the proposed device is Class A Medical Device (non-sterile and/or non-measuring), as per First Schedule of said rules.

(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 prescribed in the Medical Devices Rules, 2017.

(vi) Undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic

In addition to this, the proposed rules stated that a registration number will be generated on the online medical device system created for this purpose after the required information has been provided in accordance with Rule 19H.

In a similar vein, the new Chapter requires that anybody planning to import any of these non-sterile, non-measuring medical devices upload the necessary documentation for registration on the medical device's online registry. Once the required information has been successfully uploaded in accordance with the applicable requirements, they will also be given the registration number.

"The manufacturer/ importer shall maintain the records of manufacturing/ import along with its sales or distribution. The manufacturer and importer shall produce the records, labels, Instructions for Use, on request by Licensing Authorities. The Licensing Authorities may verify the records, documents at any point of time and investigate quality or safety related failures or complaints." the notice added.

Furthermore, in regards to the manufacturing and import of Class A (non-sterile and/or non-measuring) medical devices, it is added that in the said rules, in the Eighth Schedule, in the table under heading "Extent and conditions of exemption", after S.N. 7, the following entry shall be inserted, namely:―

To view the official notice, click the link below:

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTA0MQ==

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