Executive Summary:
This notification from the Ministry of Health and Family Welfare announces the Medical Devices Second Amendment Rules, 2019, further amending the Medical Devices Rules, 2017. These amendments, which come into force on the date of publication in the Official Gazette, relate to specific entries in the Fifth Schedule, Annexure A, concerning medical devices: Condoms and Surgical Dressings. The original draft was published on July 19, 2018, with a 30-day period for public feedback, none of which was received.
Key Points / Main Content:
Amendments to Medical Devices Rules, 2017:
* The Medical Devices Rules, 2017 are further amended by the Medical Devices Second Amendment Rules, 2019.
* These rules come into force on the date of their publication in the Official Gazette.
Fifth Schedule, Annexure A Modifications:
* Condoms: The entries in the table related to the medical device "Condom" and its corresponding entries in columns 1, 2, and 3 are substituted with new entries specifying requirements for compounding, moulding, vulcanising and primary packing.
* Compounding: Well ventilated area, neat and clean environment, free from dust and other particulate matter
* Moulding: Well ventilated area, neat and clean environment, free from dust and other particulate matter
* Vulcanising: Normal Air
* Primary Packing: Air Conditioned
* Surgical Dressings: The entries in the table related to the medical device "Surgical dressings" and its corresponding entries in columns 1, 2, and 3 are substituted with new entries specifying requirements for final primary packing.
* Sterile surgical dressings: Final Primary Packing
Impact Analysis:
Manufacturers of Condoms and Surgical Dressings:
* Impact: The amendment changes the requirements for manufacturing environments, specifically conditions for compounding, moulding, vulcanising and packing of condoms, as well as primary packing of sterile surgical dressings.
* Action Required: Manufacturers must ensure their facilities and processes comply with the new requirements to maintain compliance with Medical Device Rules.
Regulatory Bodies (e.g., Central Government, Drugs Technical Advisory Board):
* Impact: Requires enforcement and oversight to ensure manufacturers adhere to the updated rules.
* Action Required: Implement and enforce the new rules, including updating guidance documents and inspection protocols.
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 as the source of the powers exercised in this notification.
Medical Devices Second Amendment Rules, 2019: The title of the amendment rules being introduced by this notification.
Ministry of Health and Family Welfare: The Indian government ministry responsible for health policy in India.
New Delhi: The location where the notification was issued.
Drugs Technical Advisory Board: A board that the Central Government consults with regarding amendments to the Medical Device Rules.
Dr. Mandeep K. Bhandari: The Joint Secretary who signed the notification.
Mayapuri, New Delhi: Location of the Government of India Press.
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[फा. सं. ए8स -11014/17/2018-डीआर]
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MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 18th March, 2019
G.S.R. 224(E).—Whereas a draft of certain rules further to amend the Medical Devices Rules, 2017 was
published as required under 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 660(E) dated the 19th July, 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 21st July, 2018;
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 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 Device Rules, 2017, namely:-
1. (1) These rules may be called the Medical Devices (Second 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 Fifth Schedule, in Annexure ‘A’, in the Table,-¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
(a) for the entries relating to the medical device “Condom” and entries relating thereto in column (1), (2)
and (3) thereof, the following entries shall be substituted, namely:-
“Condoms Compounding Well ventilated area with neat and clean
environment, free from dust and other particulate
matter
Moulding Well ventilated area with neat and clean
environment, free from dust and other particulate
matter
Vulcanising Normal Air
Primary Packing Air Conditioned” ;
(b) for the entries relating to the medical device “Surgical dressings” and entries relating thereto in
column (1), (2) and (3) thereof, the following entries shall be substituted, namely:-
“Sterile surgical dressings Final Primary Packing 9”.
[F.No. X.11014/17/2018-DR]
Dr. MANDEEP K. BHANDARI, Jt. Secy.
Note: The principal rules were published in the Official Gazette vide notification number 78(E), dated 31st January,
2017 and last amended vide notification number G.S.R. 30(E), dated the 15th January, 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.