Executive Summary:
This notification from the Ministry of Health and Family Welfare announces a draft of amendments to the Medical Devices Rules, 2017. It solicits objections and suggestions from the public, which must be submitted within 30 days of the draft rules being made available. The proposed amendments pertain to the classification of medical devices and the authorities responsible for licensing.
Key Points / Main Content:
* **Amendments to Medical Devices Rules, 2017:**
* The notification proposes further amendments to the Medical Devices Rules, 2017.
* These rules are issued under the authority of sections 12 and 33 of the Drugs and Cosmetics Act, 1940.
* **Public Consultation:**
* The draft rules are published for public information.
* Objections and suggestions are invited and will be considered by the Central Government.
* Submissions should be addressed to the Under Secretary Drugs, Ministry of Health and Family Welfare.
* The deadline for submitting feedback is 30 days after the draft rules are made available.
* **Specific Rule Amendments:**
* **Rule 91 Amendment:** After the words "may apply to the Central Licensing Authority", the words "for Class C and Class D and State Licensing Authority for Class A and Class B" shall be inserted.
* **Second Schedule Amendment:** In the Second Schedule, at serial number 51, in column 3, the word "distinct" will be substituted with the words "category of."
Impact Analysis:
* **Medical Device Manufacturers/Applicants:**
* *Impact:* The amendment to Rule 91 impacts which licensing authority (Central or State) they need to apply to, depending on the class of medical device (A, B, C, or D). The amendment to the Second Schedule modifies the classification criteria for medical devices.
* *Action Required:* Review the amended rules to determine the appropriate licensing authority for their devices. Re-evaluate device classification based on the change in wording from “distinct” to “category of”.
* **Central Licensing Authority:**
* *Impact:* The amendment to Rule 91 clarifies their responsibility for Class C and Class D medical device licenses.
* *Action Required:* Prepare for the changes in application volume based on the amended rules.
* **State Licensing Authority:**
* *Impact:* The amendment to Rule 91 clarifies their responsibility for Class A and Class B medical device licenses.
* *Action Required:* Prepare for the changes in application volume based on the amended rules.
* **Public:**
* *Impact:* The public is affected as these rules ensure the safety and quality of medical devices available in the market.
* *Action Required:* Review the draft rules and provide suggestions/objections to the Ministry of Health and Family Welfare within the specified timeframe if they have concerns.
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 act under which the current notification regarding amendments to the Medical Device Rules is issued, specifically referencing sections 12 and 33.
Drugs Technical Advisory Board: A board consulted in the process of amending the Medical Device Rules.
Ministry of Health and Family Welfare: The government ministry responsible for the notification and the Medical Device Rules.
New Delhi: The city where the Ministry of Health and Family Welfare is located and the notification was issued.
Central Government: The governing body proposing the amendments to the Medical Device Rules.
Dr. Mandeep K. Bhandari: The Joint Secretary who signed the notification.
Central Licensing Authority: An authority mentioned in the context of Class C and Class D medical devices.
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MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 7th December, 2018
G.S.R. 1187(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 sections 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and after
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 or after the expiry of a period of thirty days from the date on which the copies of
the Gazette of India 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. (1)These rules may be called the Medical Devices (......Amendment) Rules, 2018.
(2) They shall come into force on the date their final publication in the Official Gazette.
2. In the Medical Devices Rules, 2017(hereinafter referred to as the said rules), in rule 91, after
the words “may apply to the Central Licensing Authority” the words “for Class C and Class D and
State Licensing Authority for Class A and Class B” shall be inserted.¹Hkkx IIµ[k.M 3(i)º Hkkjr dk jkti=k % vlk/kj.k 3
3. In the said rules, in Second Schedule, at serial number 51, in column 3 for the word
“distinct”, the words “category of” shall be substituted.
[F. No. X.11014/29/2018-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
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.