March Medical Device & IVD Regulatory Affairs Roundup
Andaman Medical
Regulatory affairs and market access experts for medical devices and IVD’s in Southeast Asia
Hello there,
Here are the latest #MedicalDevice #RegulatoryAffairs stories from March.
Regulatory Roundup
March 13, 2023 | Malaysia ????
This guidance document is intended to provide guidance for the requirements of custom-made medical devices that are eligible to be exempted under Medical Order 2016.
Singapore: Fifth Revision of GN-21: Guidance On Change Notification For Registered Medical Devices
March 13, 2023 | Singapore ????
With this revised guidance, it is informed that the Safety and Performance Declaration will no longer be required for Change Notification submission.
March 21, 2023 | Vietnam ????
The Vietnam Government signed and released Decree No. 07/2023/N?-CP amending and supplementing some articles of Decree No. 98/2021/N?-CP about medical device management, which takes effect immediately.
March 24, 2023 | Malaysia ????
This guidance document was prepared by the Medical Device Authority (MDA) to provide the classification of a list of products used for rehabilitation, physiotherapy, and speech therapy by determining whether they are medical devices or non-medical devices based on their intended purpose as claimed by the manufacturer.
Malaysia: MDA Released Second Edition Guidance Documents for Product Classification
March 27, 2023 | Malaysia ????
This guidance document is a revised version of MDA/GL/06 that was released in October 2021, that provides guidance, reference, and clarification on how to apply for Product Classification that are regulated under the Medical Device Act (Act 737).
March 27, 2023 | Malaysia ????
The MDA announced that they will withdraw the medical device registration (new and re-register) application and change notification application that has not been completed within 30 working days, starting from 1st April 2023.
Singapore: HSA has been recognized as a comparable overseas regulator for medical devices by the TGA
March 28, 2023 | Singapore ????
As released on the HSA NEX2US Issue 09 Newsletter (March 2023), Australia’s Therapeutic Goods Administration (TGA) recognized The Health Sciences Authority of Singapore (HSA) as a Comparable Overseas Regulator (COR) with comparable system for the evaluation of medical devices from September 2022.
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Mourad Kholti: Embarking On The Journey Of Entrepreneurship In Pursuit Of Freedom And Creativity
March 13, 2023 | Singapore ????
I am honoured to share that I have been featured in Healthcare Entrepreneurs vol 9 issue 2 as one of APAC 'Most Influential Healthcare Entrepreneur of the Year, 2023'!
If you've been following my journey, you'll know how passionate I am about healthcare tech. It is my belief that it should be more accessible, affordable, and with better patient outcomes. That's just part of the Andaman Medical story!
I wouldn't be able to celebrate such milestones without the support and hard-work of my incredible, like-minded team though. A huge thank you to you all, this is for you too!
Whether you've already registered medical devices or IVDs in Southeast Asia, or it's a new venture for you, we can help:
?? Regulatory services
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We have local regulatory affairs specialists ready to help with your strategy in Cambodia, Indonesia, Malaysia, Philippines, Singapore, Thailand, and Vietnam.
Kind regards,
Mourad Kholti
CEO, Andaman Medical
Tel. +60 4566 0200 Email: [email protected]
Our mailing address is:
Andaman Medical Pte Ltd (Head office)
Tampines Junction Business Center
Level 09-02, 300 Tampines Avenue 5
Singapore 529653
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