Regulatory affairs and market access for medical devices & IVDs across Southeast Asia since 2013 From registration to ongoing authorized representation for post-market surveillance and compliance; from importation including customs clearance to distribution of your products, we promise to get your medical device to your customer. We focus exclusively on medical devices and IVDs across […]
Regulatory updates, Vietnam On October 4, 2024, the Ministry of Health (MoH) of Vietnam issued three notices—Notice No. 6065/BYT-HTTB to the Department of Health (DoH), Notice No. 6066/BYT-HTTB to medical device manufacturers, and Notice No. 6067/BYT-HTTB to traders, exporters, and importers—calling for a survey of the current situation and gathering feedback on the draft of
Vietnam: Survey and Gathering Feedback for the Draft of Medical Device Law Read More »
Regulatory updates, Thailand On October 11, 2024, the Thai Food and Drug Administration (FDA) published new guidelines on labeling requirements for medical devices. These guidelines provide clarity on how labels should be attached to medical devices intended for both home use and professional use. The key points of the guidelines are as follows: 1. Labeling
Thailand: Guidelines for Attaching Medical Device Labels Read More »
The Minister of Communications and Informatics in Indonesia has issued Regulation No. 5 of 2024, establishing rules concerning the determination of Telecommunications Equipment and Devices Testing Centres. This regulation supersedes Ministerial Regulations No. 15 of 2012 (Guidelines for Recognition of Domestic Test Centres) and No. 16 of 2012 (Guidelines for Recognition of Overseas Test Centres).
On October 4, 2024, Thai FDA released an announcement in their website about processes involving approved license. The Thai FDA defines the following: Refer: For the process that requires referring the approved dossier of medical devices to new dossiers with changes new name for the medical device (Change of Brand Name). Transfer: For the process
On October 3, 2024, the Thai FDA announced updates to the consent form used for the Reliance Program. In the updated version, it is no longer necessary to include the reference number for the application submission to the Thai Food and Drug Administration. Applicants can now prepare the consent form and submit it along with
Last September 30, 2024, the Thai FDA Facebook page shared an infographic on how to classify wound dressing products according to the Thai Medical Device Act B.E. 2551 (2008), as amended by the Medical Device Act (No. 2) B.E. 2562 (2019). Related stakeholders shall consider the criteria when determining whether or not wound dressing products can
Thailand: Classifying Wound Dressing Products as Medical Devices Read More »
On October 2, 2024, the Thai FDA published an infographic on its official website about the Renewal, Termination, and Non-Renewal of five (5) Thai FDA Licenses applicable for local importers and manufacturers. The steps to be taken are as follows: Download the forms from the Medical Device Control Division’s website. Register for an OPEN ID
On September 12, 2024, the Ministry of Health (MoH) of Vietnam issued Official Letter No. 365/HTTB-ĐKKD concerning the handling of medical device import applications submitted before January 1, 2022, which have not been approved yet. The key points are as follows: 1. Review of Pending Applications: applicants must review their import dossiers submitted before January
Vietnam: Handling of Unapproved Medical Devices Import Application Submitted Before 2022 Read More »
The Health Sciences Authority (HSA) Singapore conducted a workshop to elaborate on the correct procedures, processes, roles and responsibilities of a registrant and a dealer during submission of documents with the Medics and Oscar systems. The highlighted information is as below: Listing of existing tools and guidelines for specific group of Medical Device/IVD. Various guidelines
Singapore: Guidance for Good Submission Practice Read More »
On September 9, 2024, TFDA released an amendment of Ministry of Public Health Notification, RE: Medical Devices that Must Display Expiration Dates, Warnings, Contraindications, or Precautions on Labels or Instruction For Use B.E. 2563 (2020), dated on April 27, 2020. By virtue of the provisions in Section 5 paragraph one, and Section 6 (13), and
On September 9, 2024, TFDA released an amendment of the “Ministry of Public Health Notification, RE: Medical Devices to be Sold Only to Health Care Unit or Medical Practitioner and Public Health Professionals B.E. 2563 (2020) dated on April 27, 2020”. By virtue of the provisions under Section 5 paragraph one and Section 6 (10)
On September 9, 2024, TFDA released an amendment of the “Ministry of Public Health Notification, RE: Standards of Medical Devices that Manufacturers or Importers Must Comply With, B.E. 2563 (2020), dated on April 27, 2020”. By virtue of the provisions in Section 5, paragraph one, and Section 6 (4) of the Medical Device Act B.E.
On September 20, 2024, Thai FDA released the guidelines for submitting applications to manufacture and import Licensed and Notified Medical Devices on the condition that referencing existing documents, document transfer, or other cases of medical devices that have previously been approved and not required academic documents evaluation by experts, government agencies, organizations designated by Thai
