Executive Summary:
This notification announces a draft of amendments to the Medical Device Rules, 2017, proposed by the Central Government in consultation with the Drugs Technical Advisory Board, under the Drugs and Cosmetics Act, 1940. The purpose is to further amend the existing rules. Consideration will be given to the draft rules after 30 days from the date the Gazette of India is made available to the public.
Key Points / Main Content:
* **Amendment to Medical Device Rules:**
* The notification pertains to draft rules for amending the Medical Device Rules, 2017.
* **Legal Basis:**
* The amendments are proposed under Section 12 and Section 33 of the Drugs and Cosmetics Act, 1940.
* **Public Consultation:**
* The draft rules are published for public information, and feedback is invited.
* Objections and suggestions will be considered if received within 30 days of the Gazette's availability.
* Feedback should be sent to the Under Secretary Drugs, Ministry of Health and Family Welfare, or emailed to drugsdivmohfwgov.in.
* **Specific Amendments:**
* Amendments are made to the Fifth Schedule, Annexure A, concerning condoms and surgical dressings.
* Specific changes are detailed for compounding, molding, vulcanizing, primary packing, and final primary packing of condoms and sterile surgical dressings, including ventilation and environmental requirements.
Impact Analysis:
* **Medical Device Manufacturers (Condoms and Surgical Dressings):**
* Impact: Manufacturers of condoms and surgical dressings will need to adhere to the revised manufacturing and packing environment specifications.
* Action Required: Review and update manufacturing processes and facilities to comply with the new ventilation and environmental requirements for compounding, molding, vulcanizing, primary packing, and final primary packing.
* **Regulatory Bodies (e.g., Ministry of Health and Family Welfare):**
* Impact: Responsible for implementing and enforcing the amended Medical Device Rules, 2017.
* Action Required: Review public feedback on the draft rules, finalize the amendments, and ensure effective implementation and monitoring of compliance.
* **Public:**
* Impact: The public is affected as the changes aim to ensure higher quality medical devices.
* Action Required: Review the draft rules and provide feedback to the Ministry of Health and Family Welfare within the specified timeframe if they have any objections or suggestions.
Key Entities Referenced
Medical Device Rules, 2017: A set of rules pertaining to medical devices, which is being amended by the current notification.
Drugs and Cosmetics Act, 1940: The principal act that confers powers to the Central Government to make rules regarding drugs and cosmetics, including medical devices.
Drugs Technical Advisory Board: A board consulted by the Central Government when making rules under the Drugs and Cosmetics Act, 1940.
Ministry of Health and Family Welfare: The government ministry responsible for health and family welfare in India, which is issuing the notification.
Nirman Bhavan, New Delhi: Location of the Ministry of Health and Family Welfare in New Delhi, India.
Medical Devices ......Amendment Rules, 2018: The short title of the rules being introduced to amend the Medical Device Rules, 2017.
Fifth Schedule: A schedule within the Medical Devices Rules, 2017 that is being amended in this notification, specifically Annexure A.
DR SUDHIR KUMAR: Joint Secretary who is responsible for the notification
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MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 19th July, 2018
G.S.R. 660(E).—The following draft of certain rules further to amend the Medical Device Rules, 2017, which
the Central Government proposes to make, in exercise of the powers conferred by section 12 and section 33 of the Drugs
and Cosmetics Act, 1940 (23 of 1940), in consultation with the Drugs Technical Advisory Board is hereby published for
information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken
into consideration on or after the expiry of a period of thirty days from the date on which copies of the Gazette of India
containing these draft rules are made available to public;
Objections and suggestions which may be received from any person within the period specified above will be
considered by the Central Government;
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of Health and
Family Welfare, Government of India, Room No. 414 A, D Wing, Nirman Bhavan, New Delhi - 110011 or emailed at
drugsdiv-mohfw@gov.in.
DRAFT RULES
1. These rules may be called the Medical Devices (......Amendment) Rules, 2018.¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
2. In the Medical Devices Rules, 2017, in the Fifth Schedule, in Annexure ‘A’, under the columns for the
entries relating to condom and surgical dressings the following shall be substituted respectively,
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
Sterile surgical dressings Final Primary Packing 9
[F. No. X.11014/17/2018-DR]
SUDHIR KUMAR, Jt. Secy.
Note : The principal rules were published in the Official Gazette vide notification number. X.11035/374/2016-DFQC,
dated 31st January, 2017 and last amended vide notification number G.S.R. .......... (E), dated..............
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.