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OTHERS SEACERA GROUP BERHAD ('SEACERA" OR "THE COMPANY") -Medical Device Authority Establishment License

SEACERA GROUP BERHAD

Type Announcement
Subject OTHERS
Description
SEACERA GROUP BERHAD ('SEACERA" OR "THE COMPANY")
-Medical Device Authority Establishment License

Reference is made to the Company's announcement dated 18 November 2021. Unless otherwise defines, the terms used in this announcement shall have the same meanings as those in the earlier announcement.

 

The Board of Directors of Seacera wishes to clarify that the original Medical Device Authority ("MDA") Establishment License Certificate dated 1 November 2021 was received by the Company on 18 November 2021. This MDA Establishment License under Section 15(1) 737 Act, is a general approval given by MDA to allow Seacera Care Sdn Bhd (formerly known as Seacera Polymer Sdn Bhd) ("SCSB") to import and distribute any medical devices with the MDA license. However, prior to the importation and distribution of any medical devices, SCSB must register and get the necessary approval for any specific products from MDA. 

 

As of to-date, no medical device has been given approval by the MDA and SCSB had on 15 November 2021 submitted an application for registration of the device known as "Portable X-Ray Equipment Model Mine 2.1". The application is still pending approval from MDA. 

 

This announcement is dated 19 November 2021. 

 

 






Announcement Info

Company Name SEACERA GROUP BERHAD
Stock Name SEACERA
Date Announced 19 Nov 2021
Category General Announcement for PLC
Reference Number GA1-19112021-00065




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