Kerala HC: PIO Doesn’t Have Authority to Start Investigative Process under Section 7 of RTI Act  ||  Delhi HC: Conditional Order Must be Complied with Strictly  ||  Delhi High Court: No Entitlement of Registration in India if Trademark Registered in Other Countries  ||  Delhi High Court: Controller of Patents Must Clearly Specify ‘Known Substance’ in Hearing Notice  ||  Patna HC: JJ Act is Based on the Belief that Children are the Future of the Society  ||  Delhi High Court: No Immunity Under FEMA for Offence Covered Under IPC  ||  SC: Statutory Mandates Under MSMED Act Cannot be Overridden by Private Arbitration Clauses  ||  SC: High Time that Arbitr. Clauses are Phrased With Precision & Not Couched in Ambiguous Phraseology  ||  SC Criticises Telangana Government for ‘Pre-Planned’ Cutting of Trees in Kancha Gachibowli  ||  Supreme Court: Crude Soybean Oil is Eligible for Customs Duty Exemption    

Medical Devices (Amendment) Rules, 2018- (Ministry of Health and Family Welfare) (01 Aug 2018)

MANU/HFAM/0099/2018

Law of Evidence

Whereas a draft of certain rules to amend the Medical Device Rules, 2017 was published as required under sections 12 and 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 412(E) dated 27.04.2018 in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i) by the Central Government, inviting objections and suggestions from all persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which copies of the said Official Gazette containing the said notification were made available to the public;

And whereas, copies of the Official Gazette containing the said notification were made available to the public on the 27th April, 2018;

And whereas, all objections and suggestions received in response to the said draft notification have been duly 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, namely:-

1. (1) These rules may be called the Medical Devices (Amendment) Rules, 2018.

(2) They shall come into force on the date of their publication in the Official Gazette.

2. In the Medical Devices Rules, 2017, in the Fourth Schedule, in Part II, in paragraph (ii), for clause (h), the following clause shall be substituted, namely:-

"(h) In case of in-vitro diagnostic medical devices, performance evaluation report by the manufacturer shall be submitted by the applicant:

Provided that when the State Licensing Authority specifically requires for Class B or the Central Licence Authority for Class B, Class C and Class D in-vitro diagnostic medical devices, as the case may be, applicant shall submit the report issued by the central medical devices testing laboratory or a medical device testing laboratory registered under rule 83 or by any laboratory accredited by the National Accreditation Board for Testing and Calibration Laboratories or by any hospital accredited by National Accreditation Board for Hospitals and Healthcare Providers or by any Central Government or State Government Laboratory of any hospital or of any institute, specified by the concerned State Licensing Authority or the Central Licensing Authority".

Tags : MEDICAL DEVICES   AMENDMENT   RULES  

Share :        

Disclaimer | Copyright 2025 - All Rights Reserved