Medical Devices classified as Drugs: CDSCO releases Amendment Rules for registeration of 36 devices

New Delhi: Through a recent Gazette Notification, Central Drugs Standard Control Organisation (CDSCO) has recently released Draft Medical Devices Amendment Rules, 2019 for the registration of 36 medical devices.

These include all medical devices except those to the likes of cardiac stents, orthoepic implants, condoms, BP measurement device, glucomenters, thermometer as well as many radiological equipments including CT, MRI that were recently brought under the purview of Drugs and Cosmetics Act and hence notified as drugs earlier this year

Read Also: Eight medical devices including CT, MRI, X-ray notified as DRUGS by health ministry

The medical devices referred shall be registered with the central licensing authority via an online portal established by the Central Drugs Standard Control Organisation (CDSCO) for the purpose.

In this regard, the Government has invited objections and suggestions from stakeholders on or after the expiry of thirty days from October 18, 2019. The same may be addressed to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in.

In exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and after consultation with the Drugs Technical Advisory Board (DTAB), Draft Medical Devices Rules 2019 is published for information that reads;

In the Medical Devices Rules, 2017 (hereinafter to be referred to as said rules), after the CHAPER III, the following CHAPTER IIIA shall be inserted, namely: -

"CHAPTER IIIA REGISTRATION OF CERTAIN MEDICAL DEVICES

19A. (1) This Chapter shall be applicable to all devices notified under clause (b) of section 3 of the Act except the medical devices and devices specified in the Annexure of Eighth Schedule of these rules.

(2) The Medical devices, referred in sub-rule (1) shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation for this purpose:

Provided that registration under this Chapter shall be on a voluntary basis for a period of eighteen months from the commencement of this Chapter thereafter it shall be mandatory.

19B. (1) 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" established by the Central Drugs Standard Control Organisation for this purpose

(2) The manufacturer shall upload, -

i. name & address of the company or firm or any other entity manufacturing the medical device along with name and address of manufacturing site of medical device,

ii. Details of medical device

iii. certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device.

iv. undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic.

19C After furnishing of the above information on the "Online System for Medical Devices" established by Central Drugs Standard Control Organisation for this purpose by the applicant's, the registration number will be generated. The manufacturer shall mention the registration number on the label of the medical device.

19D (1) Any person who imports any medical device referred in rule

19A shall upload the following information relating to that medical device for registration on the "Online System for Medical Devices" established by the Central Drugs Standard Control Organisation for this purpose

(2) The importer shall upload, -

i. name of the company or firm or any other entity importing the medical device and specification and standards of that medical device,

ii. Details of medical device

iii. certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device.

iv. Free sale certificate from country of origin.

v. undertaking duly signed by the importer stating that the information furnished by the applicant is true and authentic.

19E After furnishing of the above information on the "Online System for Medical Devices" established by the Central Drugs Standard Control Organisation for this purpose by the applicant's, the registration number will be generated. Importer shall mention the registration number on the label of the medical device.

19F Central Licensing Authority may verify the documents at any point of time and investigate quality/ safety-related failure/ complaints. The Central Licensing Authority 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 therefor, cancel the registration number or suspend it for such period as the Central 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 provision of these rules.

3. In the said rules, in the Eighth Schedule, in the table relating to exemptions, after S.N. 6, the following entry and Annexure shall be inserted, namely:-

Annexure
(See rule 19A)