SMTA/Nov 2023/EBM/Min-02
Ref: SMTA/Nov 2023/EBM/Min-02
Dated 21-11-2023
MINUTES
Pursuant to the Agenda Notice dt. 07/11/2023 the 2nd Executive Body Meeting of The Surgical Manufacturers & Traders Association was held on Monday , 20th November 2023 at 5.00 PM at The association office 60 , Darya Ganj, New Delhi – 110 002.
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F. No. 29/Misc/03/2023-DC (344)
Dated:- 12.10.2023
F. No. 29/Misc/03/2023-DC (344)
Central Drugs Standard Control Organisation
Government of India
Ministry of Health and Family Welfare
Circular
Sub: Clarification on the Regulation of all Class C & D Medical Devices under Licensing regime, w.e.f 01.10.2023, as per G.S.R. 102(E) dt 11.02.2020- Regarding.
In continuation to this office Circular vide No.29/Misc/03/2023-DC(344) dated 12.10.2023 on the Regulation of all Class C & D Medical Devices under Licensing regime, w.e.f 01.10.2023, as per G.S.R. 102(E) dt 11.02.2020.
In this connection, it is to clarify that the said circular is applicable only to the manufacturers/importers who have already filed the application to Central Licensing Authority on or before 30th September 2023.
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F. No. 29/Misc/03/2023-DC (344)
Dated:- 12.10.2023
F. No. 29/Misc/03/2023-DC (344)
Central Drugs Standard Control Organisation
Government of India
Ministry of Health and Family Welfare
Circular
Sub: Regulation of all Class C & D Medical Devices under Licensing regime, w.e.f 01.10.2023, as per G.S.R. 102(E) dt 11.02.2020 – Regarding.
The Ministry of Health & Family Welfare (MoIIFW) has published notification vide S.O. 648 (F) dated 11.02.2020 specifying all medical devices under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940, which is effective from 01.04 2020.
In order to regulate all the medical devices, MoIIFW has published G.S.R. 102 (E) dated 11.02.2020 for regulation of such devices in phase wise manner. As per the said notification the Class C & D medical devices will be under licensing regime from 01.10.2023.
In the meantime, representations from various Associations and Stakeholders have been received by this office, requesting that the business continuity should not be disrupted due to the implementation of licensing regime w.e.f. 01.10.2023 for Class C & D medical devices.
In view of the above, it has been decided that, in case, i f an existing importer/ manufacturer who is already importing/ manufacturing any of the above said Class C or Class D Medical Devices, has submitted application to Central Licensing Authority, for grant of import /manufacturing licence in respect of the said device(s) under the provisions of Medical Devices Rules, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import/manufacture the said device(s) up to six months from the date of issue of this order or till the time, the Central Licensing Authority, takes a decision on the said application, which .r is earlier.
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ADC/Delhi/Circular/2023-24/224-228
Dated:- 11.10.2023
GOVERNMENT OF INDIA
MINISTRY OF HEALTH & FAMILY WELFARE
DIRECTORATE GENERAL OF HEALTH SERVICES
CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (COSCO)
OFFICE OF THE ASSISTANT DRUGS CONTROLLER (INDIA)
ROOM No.4-A, Import-||| Building , IGI Cargo Complex,
New Delhi-110037
Circular / Notice
Sub: Submission of documents / files in online mode for imported consignment at the O/o ADC (I), IGI, Airport – regarding.
With reference to order dated 10. 10.2023 received from CDSCO, HQ, New Delhi on the subject cited above. It .is noted that applicants are submitting the applications/documents in physical file for release of imported consignment to the O/o ADC(I), IGI Airport, New Delhi.
In this regard, you are requested to submit the applications/documents for obtaining NOC for imported consignment by email only (i.e. adcigia@cdsco.nic.in) to the O/o ADC(I). No Physical files will be accepted from 16.10.2023 (Monday) for issuing of NOC.
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SMTA/SEP 2023/EBM/Min-17
Ref: SMTA/SEP 2023/EBM/Min-17
Dated 18-09-2023
MINUTES
Pursuant to the Agenda Notice dt 13/09/2023 the 17thExecutive Body Meeting of The Surgical Manufacturers & Traders Association was held on Saturday , 18thSeptember 2023 at 6.00 PM at The Jaypee Siddharth , Rajendra Place , New Delhi.
The Following members were present .
1 : Mr Pradeep Chawla ( in the chair )
2: Mr. Puneet Bhasin
3: Mr.Harpreet Singh
4 Mr. Anurag Seth
5: Mr.Satish Mahajan
6: Mr.Rakesh Sawhney
7: Mr. Ramesh Bhasin
8: Mr. Rajesh Narula
9: Mr. Ramesh Bhatia
10: Mr. Ashu Sareen
11: Mr. Rajesh Sawhney
12: Mr. Rakesh Arora
13: Mr. Vishal Anand
14: Mr. Jasmeet Singh
15 : Mr. Prashant Narula
It was pointed out in the EBM that earlier the Price Control Regulation in Drug Act probably had a turnover based exemptions, so it needs to be clarified further with the Drugs department . It was
also suggested by Mr Prashant Narula that we should approach a forum called YBL to highlight the problems being faced by the micro / small enterprises due to regulatory overreach caused on account of medical devices being declared as drugs . There being no other matter , the meeting came to an end with thanks to the chair.
For The Surgical Manufacturers & Traders Association,
Harpreet Singh
Secretary
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SMTA Directory 2024 Advertisement Bidding
RAJESH SAWHNEY
CHAIRMAN
Publication Sub–Committee SMTA
(Mobile) +91 98110 23779
rajesh@sahnisons.com
Honourable Fellow members – SMTA Greetings of the day!
I take this opportunity to bring to your kind notice that publishing of a NEW edition of SMTA Directory is now on anvil.
As decided by the management, the Regular Colour Advertisement inserts to this edition would cost Rs. 12,000.00 (Rupees Twelve Thousand Only) per leaf of the directory. However, there would be some Premium pages and locations which would be open for Auction.
The above said decision was taken in the 14th EBM of the association and I hope, that you might have received the details through the relevant minutes under Agenda item no. 4 of the said meeting published in the SMTA Broadcast WhatsApp portal.
Please find mentioned here under the details of the said Auction for your ready reference.
ADV. POSITIONING | RESERVE BID PRICE | MINIMUM INCREMENTAL BID |
BACK COVER | Rs. 1,00,000.00 | Rs. 5,000.00 |
FRONT INNER PAGE | Rs. 75,000.00 | Rs. 5,000.00 |
FRONT INNER FACING PAGE | Rs. 75,000.00 | Rs. 5,000.00 |
BACK INNER PAGE | Rs. 75,000.00 | Rs. 5,000.00 |
BACK INNER FACING PAGE | Rs. 75,000.00 | Rs. 5,000.00 |
BOOK MARK (BOTH SIDES) | Rs. 25,000.00 | Rs. 1,000.00 |
Through this communiqué, I request all interested members to send in their bids directly to me through e-mail: rajesh@sahnisons.com or my WhatsApp no. +91 98110 23779. Please note that the Top bids received will be opened in the upcoming AGM followed by a chance for in-person last and final auction there and then itself.
With Thanks & warm regards,
(Rajesh Sawhney)
Dated: 23rd August, 2023
CHAIRMAN
SMTA Publication Sub – Committee
NOTE: The sole discretion in all matters relating to the publication of SMTA Directory including its Advertisements and their auction lies with the Chairman and members of the SMTA Publication sub-committee.
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SMTA/AUG.2023 / 70thAGM awards SPONSOR/Rev
Ref: SMTA/AUG.2023 / 70thAGM awards SPONSOR/Rev
23/08/2023
SPONSORSHIP FOR AWARDS
As per tradition, three awards will be given during the forthcoming 70th Annual General Body Meeting namely;
01)The Alderman Award.
02)The Udyog Award.
03)The Sarvotam Seva Padak .
Members are hereby requested to come forward to sponsor these awards for the 70th Annual General Body Meeting to be held on Saturday, the 16 th September, 2023 at Hotel Jaypee Siddharth , 3 Rajendra Place , New Delhi-110008
Interested Members may kindly contact ;
Shri Ashok Sareen ji ( Head –Panel of Judges , Award Committee )
c/o M/s Medicon ,
1581/3, Bhagirath Palace Delhi-110006 ,
Ph : 9810293904 ,
Email : medicon16@gmail.com
Awaiting an early response.
Regards,
For The Surgical Manufacturers & Traders Association,
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SMTA/AUG 2023/EBM/Min-14
Ref: SMTA/AUG 2023/EBM/Min-14
Dated 22-08-2023
MINUTES
Pursuant to the Agenda Notice dt 11/08/2023 the 14thExecutive Body Meeting of The Surgical Manufacturers & Traders Association was held on Saturday , 19August 2023 at 5.00 PM at registered office of the association, 60 Darya Ganj , New Delhi-110002
The Following members were present . Due to lack of quorum the meeting was adjouned till 5.30 pm and then started as per agenda
1 : Mr Pradeep Chawla ( in the chair )
2: Mr.Puneet Bhasin
3: Mr. Harpreet Singh
4: Mr.Anurag Seth
5: Mr.Satish mahajan
6: Mr. Ashu Sareen
7: Mr. Rakesh Sawhney
8: Mr.RajeshNarula
9: Mr.S.B.Sawhney
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SMTA/AUG 2023/EBM/Min-15
Ref: SMTA/AUG 2023/EBM/Min-15
Dated 23-08-2023
MINUTES
Pursuant to the Emergent Agenda Notice dt 22/08/2023 the 15th Emergent Executive Body Meeting of The Surgical Manufacturers & Traders Association was held on Tuesday , 22 August 2023 at 9.00 PM by ZOOM online as per link circulated
The Following members were present .
1 : Mr Puneet Bhasin ( in the chair )
2: Mr. Harpreet Singh
3: Mr. Anurag Seth
4 Mr. Rakesh Sawhney
5: Mr. Rajesh Sawhney
6: Mr.Rakesh Arora
7: Mr. Jasmeet Singh
8: Mr. Ashu Sareen
Regrets: Mr. Pradeep Chawla
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SMTA/Aug-2023/AGM-70/Agenda
Ref: SMTA/Aug-2023/AGM-70/Agenda
Date: 22 August 2023
AGBM INVITE & AGENDA NOTICE
The 70th Annual General Body Meeting of The Surgical Manufacturers and Traders Association will be held on Saturday, the 16th September, 2023 at 7.30PM. The venue of meeting is Hotel Jaypee Siddharth, 3, Rajendra Place, New Delhi-110008.
The Agenda of the AGM is here as under:-
- Welcome Address by the President.
- Confirmation of minutes of the 69th AGBM held on 7th November 2022.
- Approval and Adoption of Resolution(s) if any passed by the Executive Body.
- Adoption of the Audited Annual Accounts.
- Appointment of Auditors for next term.
- Introduction with New Members
- Award Distribution
- Certificate Distribution for Governing Body.
- Unveiling of Members Certificate.
- Lucky Draw for Early Birds *
- Secretary’s Report.
- Auction of Prime pages of Directory
- Any other matter with permission of the Chair.
- Election of the office bearers for the next term 2023-24 to 2024-25
- National Anthem.
You are requested to kindly grace the occasion with your benign presence.
Note: The Quorum for the meeting will be observed till 07.30PM. In case the quorum is not there, the meeting will be adjourned for half an hour and will resume at 08.00 pm for which no minimum quorum is required.
* As per SMTA Constitution Only ONE Partner / Director or Proprietor can represent the member firm. THE OTHER PARTNER / DIRECTOR OF THE MEMBER FIRM will be considered as Guest.
A charge of Rs.2,000/- per Guest* will be applicable.
First 50 registered members as listed in the attendance register at the AGM shall be eligible for Early bird lucky draw
With warm Regards,
Harpreet Singh
Secretary – SMTA
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