January Regulatory Affairs Updates
Andaman Medical
Regulatory affairs and market access experts for medical devices in Southeast Asia
Hello there,
We'd like to take the opportunity to wish you a Happy Lunar New Year. May the Year of the Dragon bring you joy and prosperity ????
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 January across the ASEAN region.
Regulatory Roundup?
January 3, 2024 | Malaysia ????
On December 14th, 2023, the Medical Device Authority (MDA) of Malaysia issued a requirement for surveillance report on implantable medical devices on the homepage of Medcast 2.0+ system.
January 3, 2024 | Philippines?????
The Center for Device Regulation, Radiation Health, and Research (CDRRHR) of the Food and Drug Administration (Philippines) have announced that they will be conducting an inventory and processing of the pending applications for registration of medical devices.
January 3, 2024 | Singapore
On 15 December 2023, Health Sciences Authority (HSA) Singapore issued a medical device advisory to alert industry stakeholders to cybersecurity vulnerabilities known as “5Ghoul”.
January 9, 2024 | Philippines?????
On December 29, 2023, PFDA issued Circular No. 2023-012, listing Accredited Technical Service Providers for Radiation Dosimetry of Individual Monitoring Services.
January 17, 2024 | Singapore ????
The Health Sciences Authority (HSA) of Singapore announced regulatory fees revision pertaining to health products including medical devices, to be effective on 1 July 2024.
January 17, 2024 | Vietnam ????
On 31 December 2023, the Ministry of Health (MoH) of Vietnam temporarily froze the online system for the submission of class C and D medical devices.
January 17, 2024 | Thailand ????
The Ministry of Public Health (MOPH) in Thailand issued a draft guidance on criterions, procedures, and conditions for the production of medical devices that are exempt under Section 27(8) B.E. 2008.
January 17, 2024 | Thailand?????
To ensure the standardized quality, efficiency, and safety of importing or selling medical devices, which is in the interest of consumer protection, it is appropriate to establish a Quality Management System for Importing or Selling Medical Devices.
January 18, 2024 | Thailand?????
The Ministry of Public Health (MOPH) in Thailand issued a draft guidance specifying on three types of medical devices that require a production, import, or sale controller.
January 18, 2024 | Thailand?????
The Ministry of Public Health (MOPH) of Thailand issued a draft guidance specifying information that should be displayed on a sign at the production, import, or sale site of certain types of medical devices.
January 22, 2024 | Philippines ????
As part of the larger Post Market Surveillance (PMS) activity in the Philippines, the Food and Drug Administration (FDA) issued a draft on the Guideline for The Recall of Health Products.
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January 29, 2024 | Vietnam ????
The Vietnam Ministry of Health issued Decision No. 04/QD-BYT which elaborated that the appraisal of the submitted CSDT (Common Submission Dossier Template) for the purpose of medical device registration.
January 29, 2024 | Vietnam ????
The Vietnam Ministry of Health issued Decision No. 04/QD-BYT which elaborated that the appraisal of the submitted CSDT (Common Submission Dossier Template) for the purpose of medical device registration.
January 29, 2024 | Vietnam ????
The Vietnam Ministry of Health (MoH) issued Dispatch 8329/BYT-HTTB to the Local Health Department, requesting for the review on the implementation of the declaration of applicable standards within the area.
January 29, 2024 | Philippines ????
The Philippines Food and Drug Administration (FDA) issued an advisory No. 2024-0009, dated 10 January 2024, regarding Revision in the Process of Application for Certificate of Medical Device Registration (CMDR) / Certificate of Medical Device Notification (CMDN), Initial and Renewal.
January 29, 2024 | Thailand ????
Thailand FDA released several announcements related with the medical devices, including the deadline for submitting documents in full CSDT, submission of annual reports for production, import and sales of medical devices, and reclassifications of breathalyzers.
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.
Networking Meal: Singapore
We were delighted to host a wonderful meal with some of our incredible clients over in Singapore earlier in January. With beautiful food, drinks flowing, and inspiring conversations a plenty, it's always a pleasure to be able to meet, socialise and strengthen relationships.
Lastly, for those of you celebrating the holidays, we wish you a healthy, peaceful and restful festive period.
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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