February Regulatory Affairs Updates
Andaman Medical
Regulatory affairs and market access experts for medical devices in Southeast Asia
Hello there,
As we approach the final weeks of Q1, we hope that your year ahead is looking successful and promising. We will soon have some exciting news of our own to share with you about our ventures further into the dynamic Asian Medical Device and IVDs market. So be sure to keep your ear to the ground as we will be better placed to tell you all about it very, very soon!
We're pleased to announce we're hosting a webinar next week (Monday, March 4) covering everything you need to know about regulatory access in Cambodia. It's one you won't want to miss, so reserve your spot here.
Over the next few months we will be attending some prestigious industry events, including KIMES 2024 in Seoul, Korea, in March and exhibiting at CMEF in Shanghai, China, in April. If you are also attending let's put some time aside to meet!
And finally, as always, here are the latest regulatory updates from February across the ASEAN region.
Regulatory Roundup
February 1, 2024 | Thailand 🇹🇭
The Ministry of Public Health (MOPH) of Thailand issued a draft announcement for the production or sale of medical devices exempted under section 27 (2), (3), and (4).
Febuary 5, 2024 | Thailand 🇹🇭
The Ministry of Public Health (MOPH) issued a draft announcement pertaining to the criterions, procedures, and conditions for selling of medical devices in the Thai market.
Febuary 5, 2024 | Thailand 🇹🇭
The Ministry of Public Health (MOPH) of Thailand issued a draft guidance on the Temporary Storage of Medical Devices Outside the Location Specified in the Establishment Registration Certificate, Licenses, Notification Licenses, and Listing Certificates.
Febuary 19, 2024 | Singapore 🇸🇬
On 24th January 2024, the Health Sciences Authority (HSA) of Singapore issued Revision 10 of the “GN-15 Guidance on Medical Device Product Registration”. The highlighted key update, especially for the evaluation routes of Immediate Class B Registration (IBR condition 1) and Expedited Class C Registration (ECR-1).
Malaysia: MDA Released Guidance Document MDA/GD/0066: Importation of Medical Device for Personal Use
Febuary 20, 2024 | Malaysia 🇲🇾
The Medical Device Authority (MDA) of Malaysia has released Guidance Document MDA/GD/0066, First Edition, titled “Importation of Medical Device for Personal Use”, to support the industry and healthcare professionals in their efforts to comply with the Medical Device Act (Act 737) and its associated regulations.
February 20, 2024 | Malaysia 🇲🇾
The Medical Device Authority (MDA) has released Guidance Document MDA/GD/0067, First Edition, titled “Post Market Information Exchange for ASEAN Member States“, to assist the industry and healthcare professionals in complying with the Medical Device Act (Act 737) and its associated regulations.
February 20, 2024 | Vietnam 🇻🇳
On 30 December 2023, the Authority of Vietnam issued Decree 96/2023/NĐ-CP detailing several articles of the Law on Medical Examination and Treatment. Furthermore, Article 147 of this Decree has amended and supplemented some articles of Decree 98/2021/NĐ-CP regarding “Medical Device Management.”
February 20, 2024 | Philippines 🇵🇭
During the harmonization to ASEAN requirements, PFDA aims to prevent a negative impact on the supply of medical devices by issuing past provisions FC No. 2021-002A, FC No. 2021-002B, and FC No. 2021-002C (valid until Mar 31, 2024) which provide regulatory flexibility to all Class B, C, and D medical devices that are not included in the list of registrable medical devices based on FC No. 2020-001A.
Recommended by LinkedIn
Whether you've already registered medical devices or IVDs in Southeast Asia, or it's a new venture for you, we can help:
We have local regulatory affairs specialists ready to help with your strategy in Malaysia, Thailand, Indonesia, the Philippines, Vietnam, Singapore, and Cambodia.
🗓️ Upcoming Events
Webinar: Regulatory Access for Medical Devices in Cambodia
Monday, March 4, 2024 10AM – 11AM CET / 4PM – 5PM SGT
Participate in this must-attend webinar you can reserve your spot here.
KIMES
March 14 – 17, Seoul, South Korea
Our CEO, Mourad Kholti, COO, Paul Argant, and Head of Sales, ShouZheng Tan, will be at attending, and available to discuss all aspects of registering and launching your medical devices in ASEAN. If you'd like to set up a meeting, please message us to arrange.
CMEF
11 – 14 April, Shanghai, China
We're delighted to be attending the China International Medical Equipment Fair. From our team Mourad Kholti, our founder and CEO, Paul Argant, our COO, our Head of Sales, ShouZheng Tan, and BDM, Lee Wern, will be there. If you'd like to meet with us to discuss registering and launching your medical devices in ASEAN, please message us to arrange.
Kind regards,
Mourad Kholti - CEO
Andaman Medical
Tel. +60 4566 0200 Email: sales@andamanmed.com
Our mailing address is:
Andaman Medical Pte Ltd (Head office)
Tampines Junction Business Center
Level 09-02, 300 Tampines Avenue 5
Singapore 529653
Copyright © 2024 Andaman Medical, All rights reserved.