July 2024

Regulatory Affairs Update: Malaysia

Malaysia: Pilot Survey for Unique Device Identification (UDI)

On June 7th, MDA launched the first phase of the pilot survey for the implementation of Unique Device Identification (UDI) in Malaysia. The survey will be conducted in two phases, involving the following establishments and timelines (dates updated July 30 2024): Phase 1: Class D Medical Device Establishments – June 7, 2024, to August 15, […]

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Regulatory Affairs Update: Thailand

Thailand: FDA Released Draft Guidelines for Referencing Existing documents, Document Transfer, or other cases in Submitting Applications for Manufacture or Import Licenses, and Notifications for Manufacture or Import of Medical devices

On July 9, Thai FDA shared the following draft guidelines regarding license transfer and brand name amendment: The guidelines are set up for the applications that are eligible for referencing existing documents or document transfer from approval license which do not require an expert review of the documents. It covers three main scenarios: (1) When

Thailand: FDA Released Draft Guidelines for Referencing Existing documents, Document Transfer, or other cases in Submitting Applications for Manufacture or Import Licenses, and Notifications for Manufacture or Import of Medical devices Read More »

Regulatory Affairs Update: Thailand

Thailand: Arrangement of Signage for Facilities Involved in Importing/Manufacturing/Selling/Storage of Medical Devices

On July 10, Thai FDA shared an infographic regarding signage requirement for affected stakeholders: The registrants of an establishment for manufacturing or importing/licensed sellers of medical devices must arrange for signage display. The Signage must be displayed for the following: Medical device manufacturing facility Medical device selling facility Medical device importing facility Medical device storage

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Regulatory Affairs Update: the Philippines

The Philippines: PFDA Temporary Suspends LBP Oncoll Payment Facility and Addresses Payment Issues for Some Applications

Starting 01 July 2024, Payment via over-the-counter using LBP Oncoll Deposit Slip will be temporarily suspended until further notice. During this period, FDA encourages all concerned parties to utilize the following payment channels: LBP LinkBiz Portal DBP BancNet Bills Payment Over the Counter (for applications included in the Annexes of FDA Advisory No. 2024-0320) Furthermore, the

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Regulatory Affairs Update: Vietnam

Vietnam: New Circular Regulating Fees and Charges Affecting the Medical Sector

On 28 June 2024, the Vietnam Ministry of Finance issued Circular No. 43/2024/TT-BTC prescribing fees and charges to remove further difficulties for enterprises and support production and business activities. This circular reduces the fees and charges for some procedures from those regulated in previous guidelines. Accordingly, all fees and charges in the medical sector are

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Regulatory Affairs Update: Thailand

Thailand: TFDA released list of experts, organizations, government agencies, and private organizations to evaluate academic documents on medical devices

In an announcement last June 26, 2024, TFDA released an additional list of experts, expert organizations, government agencies, or private organizations, both domestic and international, to perform the evaluation of academic documents on medical devices. This is according to Section 35/2, paragraph 1 of the Medical Devices Act B.E. 2551, as amended by the Medical

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Andaman Medical: A Partner in Bio Preventive Medicine Corporation’s Expansion

Bio Preventive Medicine Corporation (BPM) is a leading biotech company specialising in renal biomarkers. With a focus on translating validated and IP-protected novel biomarkers into diagnostic solutions for unmet clinical needs, BPM has developed innovative products that are revolutionising the field of kidney disease diagnosis and management. One such product is the DNlite-IVD103, a non-invasive

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Regulatory Affairs Update: Thailand

Thailand: Classifying Massage Equipment and Vibrating Devices as Medical Devices

Massage equipment and vibrating devices are commonly used for various purposes, but not all of them are classified as medical devices. The classification depends on their intended use and the claims made by the manufacturer. Here’s a breakdown of how these devices are classified according to the Medical Device Act B.E. 2551 (2008), as amended

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Regulatory Affairs Update: Thailand

Thailand: Draft Announcement of Guidelines for Submitting Applications for Medical Device Advertisement that Requires Academic Document Evaluation

On May 20, 2024, the Ministry of Public Health of Thailand issued a notification regarding medical devices prohibited from direct sales or direct marketing under the law governing Direct Sales and Direct Marketing. By Section 5, Paragraph One, and Section 6 (12) of the Medical Device Act B.E. 2551 (2008), the Minister of Public Health,

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Regulatory Affairs Update: Thailand

Thailand: The Principles and Methods of Transportation, Storage, Destruction, or Disposal of Medical Devices

The Minister of Public Health, upon the advice of the Medical Device Committee, established the criteria and methods for the transportation, storage, destruction, or disposal of medical devices under the Authority conferred by Section 5, Paragraph One, and Section 6 (16) of the Medical Device Act B.E. 2551 (2008). Under this regulation, the registrants of

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Regulatory Affairs Update: Thailand

Thailand: Draft Announcement of Guidelines for Submitting Applications for Medical Device Advertisement that Requires Academic Document Evaluation

The Secretary-General of the Food and Drug Administration hereby issues the draft announcement as follows: Section 1: This Announcement shall be effective from the day following its publication in the Government Gazette. Section 2: Guidelines for submitting applications for medical device advertising that requires academic document evaluation are as follows: Display of advertising messages that

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Regulatory Affairs Update: Thailand

Thailand: Requirement of Signage to Display Names and Qualifications of Supervisors for Production, Import, or Sale of Medical Devices

Following the authority conferred by Section 5(1) of the Medical Device Act B.E. 2551 (2008) and Section 41(7) as amended by the Medical Device Act (No. 2) B.E. 2562 (2019), the Minister of Public Health hereby issues the following announcement: The registrant shall prepare signage to display the supervisor’s name and qualifications to control production,

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Regulatory Affairs Update: Thailand

Thailand: Supervisors’ Qualifications and Duties for Control of Production, Import, or Sale of Medical Devices

On May 20, 2024, the Ministry of Public Health of Thailand issued a notification governing medical devices that require Supervisors for Control of Production, Import, or Sale and the qualifications, number, and duties of such supervisors, B.E. 2567 (2024). Medical device operators must appoint at least one supervisor with qualifications and duties for production, import,

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Regulatory Affairs Update: Singapore

Singapore: NextGen MD Initiative

Effective 1st July 2024, a new registration initiative – NextGen MD, is available for product owners who are keen to market their next-generation MDs/IVDs in Singapore. The registration requirements follow the latest GN-15: Guidance on Medical Device Product Registration, with an additional task of completing the NextGen MD form. This form consists of two parts,

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Regulatory Affairs Update: Thailand

Thailand: TFDA To Change the Regulations on the Registration of Diagnostic Test Kits and Reagents for COVID-19 to Comply with International Standards

In a newsletter article last June 28, 2024, the Thailand Food and Drug Association (TFDA) shared news that they will be collaborating with agencies to discuss the draft of medical device laws to adjust the registration of diagnostic test kits and reagents for COVID-19 to be based on risk classification of medical devices and international

Thailand: TFDA To Change the Regulations on the Registration of Diagnostic Test Kits and Reagents for COVID-19 to Comply with International Standards Read More »

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