SMTA/2024-25/Dir/Circular –VI
07th July, 2024

THIS IS FINAL CALL / INFORMATION – THAT NO CHANGES / ADDITIONS WOULD BE POSSIBLE AFTER 15th OF JULY, THIS YEAR – PLEASE NOTE.

This is the FINAL call for sending your Data correction / Data addition details and Advertising requests along with its Print materials and tariff charge.
All were requested to please rush their Data/Corrections and valued Advertisements so that the same can be taken care of. You were once again requested to please expedite the same because the details received beyond 30th of June may not be taken in account as the things may move on to processing mode.

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Ref No.: SMTA / CIR/ June/2024
Date: 17th June 2024

ADVISORY FOR BHAGIRATH PALACE , DELHI MEMBERS

We have received a number of enquiries from our members about upcoming Summer Holidays for which we have been informed that the other trade associations in the vicinity have decided to keep the shops closed from 20th JUNE till 22nd JUNE 2024 .

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SMTA/2024-25/Dir/Circular –V 15th June

Honourable Fellow members – SMTA
Greetings of the day!

This is the FINAL call for sending your Data correction / Data addition details and Advertising requests along with its Print materials and tariff charge. All are requested to please rush their Data/Corrections and valued Advertisements so that the same can be taken care of. You are once again requested to please expedite the same because the details received beyond 30th of June may not be taken in account as the things may move on to processing mode.

Through this communique, I request all interested members to send in their intent, relevant payments, Artworks and Data corrected in prescribed format to :

Shri Kishore S. Bhatnagar
Next Vision
3551, Sector D, Pocket 3, Vasant Kunj, New Delhi – 110 070.
Telephone : +91 99531 00231 e-mail : vision-next@email.com
OR
Directly to me through e-mail: president@smta.in or rajesh@sahnisons.com or my
WhatsApp no. +91 98110 23779.

With Thanks & warm regards,
(Rajesh Sawhney)
PRESIDENT & CHAIRMAN
SMTA Publication Sub – Committee

Note : In case some member wants to get the Artwork etc. done for his advertisement insertion – His help can be sought for the purpose – The price for one page artwork and setting has been fixed at Rs. 1,000.00 (Rupees One Thousand Only) per page. This amount has to be paid DIRECTLY to him (SMTA would not be involved directly or Indirectly in such transaction/s)

File No.: MED/48/2024-eoffice
Central Drugs Standard Control Organisation
Government of India
Ministry of Health and Family Welfare
FDA Bhawan, New Delhi
Date 29th May, 2024

CIRCULAR

Subject: Testing and evaluation of Medical Devices(MD)/ In vitro diagnostics(IVDs) by Medical Devices Testing Laboratories in the country – Reg. In order to ensure the quality, safety and performance of Medical Devices(MD)/ In vitro diagnostics (IVDs), the Ministry of Health and Family Welfare, Government of India has granted registration of Laboratory for carrying out Test or Evaluation of a Medical Device on behalf of a manufacturer, under Chapter X of Medical Device Rules 2017 to strengthen the testing facility in the country It is pertinent to mention that consequent to the implementation of MDR 2017 with effect from 01/01/2018, the Drug Rules 1945 are no longer applicable for MDs/lVDs. Also, the product standards of Medical Devices as prescribed under Rule 7 of the Medical Device Rules (MDR) are mandatory as under.

15th May, 2024

Dear Members,
As we all know that we at SMTA are in process of publishing a fresh edition of SMTA Directory and are in the process of collecting and correcting the members’ data and also collecting Advertisements (Bookings & Materials) for the  same through Mr. Kishore S. Bhatnagar (Mob.: +91 99531 00231) and Mr. Ramesh Kumar (Mob.: +91 99901 48489) of m/s VISION NEXT (E-mail : vision-next@email.com)

You are requested to please rush the materials (Completed data sheet / Advertisement materials at the earliest. All members are requested to kindly do the needful by passing on the required information without any further delay and oblige.

We are attaching separately the required data format for your ready reference and use.

With warm regards.
(Rajesh Sawhney)
Hony. President – SMTA
Dated : 15th May, 2024

Note : In case some member wants to get the Artwork etc. done for his advertisement insertion – His help can be sought for the purpose – The price for one page artwork and setting has been fixed at Rs. 1,000.00 (Rupees One Thousand Only) per page. This amount has to be paid DIRECTLY to him (SMTA would not be involved directly or Indirectly in such transaction/s)

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.

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.

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.

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 14^th 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.

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: 23^rd 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.