Preamble - MEDICAL DEVICES (AMENDMENT) RULES, 2020

MEDICAL DEVICES (AMENDMENT) RULES, 2020

PREAMBLE

Whereas a draft of certain rules further to amend the Medical Devices Rules, 2017, was published as required by under subsection (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 797 (E), dated the 18th October, 2019, in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public;

And whereas copies of the Official Gazette were made available to the public on 18th October, 2019;

And whereas objections and suggestions received from the public on the said rules have been considered by the Central Government;

Now, therefore, 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, hereby makes the following rules further to amend the Medical Devices Rules, 2017, namely:--

Rule 1 - RULE 1

(i) These rules may be called the Medical Devices (Amendment) Rules, 2020.

(ii) These rules shall come into force on the 1st day of April, 2020.

Rule 2 - RULE 2

In the Medical Devices Rules, 2017 (hereinafter to be referred as said rules), after CHAPTER 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 voluntary basis for a period of eighteen months from the commencement of this Chapter there after 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, registration number will be generated. 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. 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.

Rule 3 - RULE 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:-