No. 35026/176/2021-MD
Government of India
Ministry of Chemicals & Fertilizers
Department of Pharmaceuticals

Janpath Bhawan, New Delhi Dated 1st February, 2022

PUBLIC NOTICE

Subject:- Relaxation on Global Tender Enquiry (GTE) under rule 161(iv) of General Financial Rules (GFRs) 2017 for procurement of Medical Devices based on the requests of the procurement agencies on the grounds of non-availability of Class-I or Class-II suppliers — Confirmation of the the consolidated list of 391 Medical Devices, prior to sending the proposal to DoE through DoHFW – reg

Reference is taken to the DoP Public Notice dated 18.12.2021 vide which medical devices in two lists (493 Medical Devices viz, 128 in List-1 and 365 in List-2 of Annexure-I of the Public Notice) were published to seek the details of local manufacturers for the purpose of procurement under PPO (MII) Order, 2017. The exercise has been taken pursuant to the representations received from the procuring agencies under different Ministries of the Govt. of India such as CMSS, ESIC, AIIMS, Railway Board, DGAFMS, RITES, etc. with regard to non-availability of Class-I or Class-II suppliers for identified Medical Devices/Equipment.

MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)

NOTIFICATION
New Delhi, the 9th February, 2022

G.S.R. 104(E).—The following draft of certain rules further to amend Medical Device Rules, 2017, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and subsection (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published after consultation with the Drugs Technical Advisory Board 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 forty-five days from
the date on which copies of the Gazette of India containing these draft rules are made available to public;

REGISTRATION CERTIFICATE FOR SELLERS & DISTRIBUTORS OF MEDICAL DEVICES

This is to bring to the notice of all members – with reference to the Ministry of Health & Family Welfare’s notification no. G.S.R 104(E) containing Draft Rules for amendments to the Medical Devices Rules dated 9th Feb 2022 – A series of amendments have been proposed through which a ‘Registration Certificate to sell, stock, exhibit or of offer for sale or distribute a medical device including in vitro diagnostic medical device’ has been introduced. This will come into effect at least after 45 days from the date of the notification and through further announcements by the Ministry. In a nutshell, this Registration Certificate will replace the Drug License requirement for Dealers and Distributors of Medical Devices. The Registration Certificates will have to be applied for, and will be issued by the state licensing authorities. It is indeed a moment of pride for all SMTA members that our association’s consistent efforts and representations to various departments and the Ministry have paid off. Following our submissions to the departments regarding ‘Drug Licensing’ for traders through our letters and subsequent meetings with the various authorities – our
suggestions have been taken into consideration and these changes have been implemented.

We are confident that this in the interest of traders and will benefit all SMTA members as well as all the sellers and distributors of Medical Devices in India, bringing ease to the process and eliminating the need for drug licenses. We request you to go through the notification and for any queries please contact the SMTA Office Bearers. We will be further communicating the objections & suggestions of our members to simplify the registration process further, as we feel it can be improved. Our efforts will focus on including these suggestions before the notification comes into effect.

Thanking You,
Regards,
Pradeep Chawla
President
The Surgical Manufacturers & Traders Association

No. 35026/176/2021-MD
Government of India
Ministry of Chemicals & Fertilizers
Department of Pharmaceuticals

Janpath Bhawan, New Delhi
Dated 1st February, 2022

PUBLIC NOTICE

Subject:- Relaxation on Global Tender Enquiry (GTE) under rule 161(iv) of General Financial Rules (GFRs) 2017 for procurement of Medical Devices based on the requests of the procurement agencies on the grounds of non-availability of Class-I or Class-II suppliers — Confirmation of the the consolidated list of 391 Medical Devices, prior to sending the proposal to DoE through DoHFW – reg

Reference is taken to the DoP Public Notice dated 18.12.2021 vide which medical devices in two lists (493 Medical Devices viz, 128 in List-1 and 365 in List-2 of Annexure-I of the Public Notice) were published to seek the details of local manufacturers for the purpose of procurement under PPO (MII) Order, 2017. The exercise has been taken pursuant to the representations received from the procuring agencies under different Ministries of the Govt. of India such as CMSS, ESIC, AIIMS, Railway Board, DGAFMS, RITES, etc. with regard to non-availability of Class-I or Class-II suppliers for identified Medical Devices/Equipment.

Public Notice: No. 31026/83/2021-MD
Dated 1st February 2022

Government of India
Ministry of Chemicals and Fertilizers
Department of Pharmaceuticals

Public Notice dated 01.02.2022

Subject: List of available standards of Bureau of Indian Standards for Medical Devices — regarding

I am directed to refer to Rule 7 of Medical Device Rules, 2017 as under, which stipulates the requirement of Product Standards for medical devices :-

“Product standards for medical device —

1. The medical device shall conform to the standards laid down by the Bureau of Indian Standards established wider section 3 of the Bureau of Indian Standards Act, 1985 (63 of 1985) or as may be notified by the Ministry of Health and Family Welfare in the Central Government, from time to time.
2. Where no relevant Standard of any medical device has been laid clown under sub-rule (1), such device shall conform to the standard laid down by the International Organisation far Standardisation (1S0) or the International Electro Technical Commission (IEC), or by any other pharmacopoeia!
3. In case of the standards which have not been specified under sub-rule (I) and sub-rule (2), the device shall conform to the validated manufacturer’s “

THE GAZETTE OF INDIA : EXTRAORDINARY
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)

ORDER

New Delhi, the 31st January, 2022

S.O. 401(E).—The National Pharmaceutical Pricing Authority, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India vide S.O. 2808(E) dated 13^th July, 2021 issued notification under Para 19 of the DPCO, 2013 regarding capping the trade margin of five medical devices, namely, (i) Pulse Oximeter, (ii) Blood Pressure Monitoring Machine, (iii) Nebulizer, (iv) Digital Thermometer, and (v) Glucometer at first point of sale of the product through Trade Margin Rationalization Approach. In continuation to the above notification, capping the trade margin of five medical devices, namely, (i) Pulse Oximeter, (ii) Blood Pressure Monitoring Machine, (iii) Nebulizer, (iv) Digital Thermometer, and (v) Glucometer at first point of sale upto 31′ January, 2022 is further extended upto 31st July, 2022.

2. The Notes (b) to (m) of the Notification S.O. 2808 (E) dated 13^rh July, 2021shall remain in force dining the currency of this order.

Ref: SMTA/Jan.2022/EBM/Min-01
Dated 23-01-2022

MINUTES

Pursuant to the Agenda Notice dt 18/01/2022 the 1st Executive Body Meeting of The Surgical Manufacturers & Traders Association was held on Sunday, 23 Jan 2022 online via Zoom meetings.