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.

No. F.60/DDMA/COVID-19/2021/509
DATE: 11th January, 2022.

GOVERNMENT OF NCT OF DELHI
DELHI DISASTER MANAGEMENT AUTHORITY
No. F.60/DDMA/COVID-19/2021/509
Dated: 11.01.2022

ORDER

Whereas; the Delhi Disaster Management Authority (DDMA) is satisfied that the NCT of Delhi is threatened with the spread of COVID-19 Virus, which has already been declared as a pandemic by the World Health Organization and has considered it necessary to take effective measures to prevent its spread and has issued various orders/instructions from time to time to all authorities concerned to take all required measures to appropriately deal with the situation in NCT of Delhi;
2. And whereas, DDMA has issued Order No. 500 dated 28.12.2021 and subsequent Order No. 504 dated 04.01 .2022 (copy enclosed) with regard to permitted I prohibited I restricted activities in NCT of Delhi till further orders;
3. And whereas the COVID-19 situation in Delhi has again been reviewed in DDMA meeting held on 10.01.2022 under chairmanship of Hon’ble Lt. Governor and it has been observed that numbers of COVID-19 cases (including the cases of Omicron variant) have been rapidly increasing over the last few days &positivity rate has crossed23%.Therefore, it has been felt necessary that some more additional restrictions are required to be imposed in Delhi to contain the spread of COVID-19 virus, including the highly contagious and transmissible Omicron variant.

DATE: 2nd November, 2021.

MINISTRY OF CONSUMER AFFAIRS, FOOD AND PUBLIC DISTRIBUTION
(Department of Consumer Affairs)
NOTIFICATION
New Delhi, the 2nd November, 2021

G.S.R. 779(E).––In exercise of the powers conferred by sub-section (1) read with clause (j) and (q) of subsection (2) of section 52 of the Legal Metrology Act 2009, (1 of 2010), the Central Government hereby makes the following rules further to amend the Legal Metrology (Packaged Commodities) Rules, 2011, namely:–
1. Short title and commencement.–(1) These rules may be called the Legal Metrology (Packaged
Commodities) Amendment Rules, 2021.
(2) They shall come into force on the 1st day of April, 2022.

A

SMTA/DEC-21/Elec-1
December 10th, 2021

THE SURGICAL MANUFACTURERS & TRADERS ASSOCIATION
60-Daryaganj, New Delhi-110002. Tel. 23271027 Fax: 23258576

To ALL MEMBERS OF
The Surgical Manufacturer & Traders Association,
New Delhi-110002.

Sub.: Office Bearers & Executive Members of SMTA for the term of 2021-23

Dear Members,
While wishing you a VERY HAPPY & PROSPEROUS NEW YEAR 2022. I am pleased to inform you that in the Annual General Meeting held on 04th Dec 2021 the following were unanimously elected as the Office bearers

December 31st, 2021

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

G.S.R. 918(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. 877(E), dated the 23rd December, 2021, 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 five 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 said Official Gazette were made available to the public on 23rd December, 2021;
And whereas objections and suggestions received from the public on the said draft rules have been considered by the Central Government;