Executive Summary:
This notification announces the Medical Devices Fourth Amendment Rules, 2019, further amending the Medical Devices Rules, 2017. These amendments are made under the Drugs and Cosmetics Act, 1940, following a period for public comment, during which no objections were received. The rules come into force on the date of their publication in the Official Gazette.
Key Points / Main Content:
* **Amendment Title and Effective Date:**
* The rules are called the Medical Devices Fourth Amendment Rules, 2019.
* The rules come into force on the date of their publication in the Official Gazette.
* **Amendment to Form MD10:**
* In the Medical Devices Rules, 2017, in the Appendix, in Form MD10.
* The words "State Licensing Authority" are substituted with "Central Licensing Authority".
Impact Analysis:
* **Medical Device Manufacturers/License Holders:**
* Impact: Need to be aware of the change in terminology from "State Licensing Authority" to "Central Licensing Authority" in Form MD10.
* Action Required: Update internal documentation and processes to reflect the change to "Central Licensing Authority" in Form MD10.
Key Entities Referenced
Medical Devices Rules, 2017: A set of rules pertaining to medical devices, which is being amended by this notification.
Drugs and Cosmetics Act, 1940: An act of the Indian Parliament that regulates the import, manufacture, distribution and sale of drugs and cosmetics. Sections 12 and 33 are referenced in this notification.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India. The Department of Health and Family Welfare is a department within this ministry.
New Delhi: The capital of India, where the notification was issued.
Medical Devices Fourth Amendment Rules, 2019: The name given to the amendments to the Medical Devices Rules, 2017, as outlined in this notification.
Drugs Technical Advisory Board: A statutory body constituted by the Government of India to advise on technical matters related to drugs and cosmetics.
Central Licensing Authority: An authority replacing 'State Licensing Authority' as mentioned in Form MD10 according to the amendments.
Mandeep K. Bhandari: The Joint Secretary who signed the notification.
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MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 13th September, 2019
G.S.R. 652(E).—Whereas the draft of certain rules further to amend the Medical Devices Rules,
2017, was published as required by sub-section(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. 188(E), dated the 6th March,
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 8th March, 2019;
And whereas no objections or suggestions were received from the public on the said rules for
consideration by the Central Government;
Now, therefore, in exercise of the powers conferred by section 12 read with 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:—
1. (1) These rules may be called the Medical Devices (Fourth Amendment) Rules, 2019.
(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 Appendix, in Form MD-10, for the words “State Licensing
Authority”, the words “Central Licensing Authority” shall be substituted.
[F. No. X. 11014/31/2018-DR]
Dr. MANDEEP K. BHANDARI, Jt. Secy.
Note : The Medical Devices Rules, 2017 was published in the Official Gazette vide notification number
78(E), dated the 31st January, 2017 and last amended vide notification number G.S.R. 318(E), dated
the 18th April, 2019.
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.