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to mention that consequent to the implementation of MDR 2017 with effect from 01/01/2018, the Drug Rules 1945 are no longer applicable for MDs/lVDs.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)