Gazette calls for registrations of medical devices, details

New Delhi: Through a recent notification, the Union Health Ministry has mandated the registration of certain medical devices with the apex drug regulator, Central Drugs Standard Control Organisation (CDSCO) effective from April 1, 2020.

In exercise of the powers conferred by section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board has amended the Medical Devices Rules, 2017.

Prior to the amendment, a draft was circulated in the public domain seeking objections and suggestions. Accordingly, after receiving and considering the suggestions given by the stakeholders, the Central Government has amended the said rules. The rules may be called the Medical Devices (Amendment) Rules, 2020.

As per the amendment, in the Medical Devices Rules, 2017 (hereinafter to be referred to as said rules), after CHAPTER III, a CHAPTER IIIA will be inserted. This chapter will be called- CHAPTER IIIA REGISTRATION OF CERTAIN MEDICAL DEVICES. The details of the chapter read;

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 to 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.

Also Read: All Medical Devices To Be Classified As DRUGS, Details

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, a 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, registration number will be generated. The 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 or safety-related failure or 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)

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