Regulatory updates Archives

Singapore: HSA Public Consultation Re: Proposed Exemption from Manufacturer’s Licensing and Product Registration Requirements for AI-SaMD in Public Healthcare

June 11, 2025

The Health Sciences Authority (HSA), Singapore, seeks public consultation on exemptions from manufacturer licensing and product registration requirements for Artificial Intelligence (AI) – Software as Medical Devices (SaMDs) developed by MOH Holdings Pte Ltd (MOHT), Synapxe Pte Ltd (Synapxe), and public healthcare clusters/institutions. Scope of AI-SaMD for Proposed Exemptions Class

Thailand: Thai FDA Infographic Re: Document Supplementation System for Upgrading Submission Type from Partial (1 or 2) or Abridged to Full CSDT

June 4, 2025

The Thai Food and Drug Administration (FDA), through the Medical Device Control Division, has developed a document supplementation system to facilitate the upgrading of submission types from Partial 1, Partial 2, or Abridged to Full Common Submission Dossier Template (CSDT). This system is accessible via the TFDA’s Skynet platform and

Vietnam: Relocation of Infrastructure and Medical Device Administration

June 4, 2025

On May 21, 2025, the Vietnam Ministry of Health issued Notification No. 387/TB-HTTB, officially announcing the relocation of the Infrastructure and Medical Device Administration (IMDA) office. The new IMDA office is now located on the 7th, 8th, and 9th floors of the Ministry of Health’s 9-storey building at Alley 1,

Philippines: Department of Health approves the recommendation of Food and Drug Administration to temporarily suspend New Regulatory Fees.

June 2, 2025

The Department of Health (DOH) posted an advisory on its DOH FB page last May 30, 2025, informing the public of its approval for the temporary suspension of FDA New Regulatory Fees. The approved FDA memorandum with Subject: Recommendation to temporarily suspend the implementation of Administrative Order 2024-0016: Implementing Guidelines

Malaysia: MDA Notification: Advisory on the Use of Malaria Test Kits

May 23, 2025

On March 31, 2025, the World Health Organization (WHO) issued an advisory regarding performance concerns with certain malaria rapid diagnostic test kits (RDTs). WHO has received multiple reports indicating faint positive test lines observed in patients confirmed to have malaria, potentially affecting test reliability across several countries using these kits.

Thailand: The Implementation of the Electronic Certificate System (e-Certificate)

May 15, 2025

On April 17, 2025, the Food and Drug Administration (FDA) recognized the importance of enhancing competitiveness by developing public administration systems to provide efficient services to the public. Therefore, the electronic certificate system (e-Certificate) has been developed to meet the needs of entrepreneurs, allowing them to access services online anytime and

Regulatory Updates

Regulatory Updates

Singapore: HSA Public Consultation Re: Proposed Exemption from Manufacturer’s Licensing and Product Registration Requirements for AI-SaMD in Public Healthcare

Thailand: Thai FDA Infographic Re: Document Supplementation System for Upgrading Submission Type from Partial (1 or 2) or Abridged to Full CSDT

Vietnam: Relocation of Infrastructure and Medical Device Administration

Philippines: Department of Health approves the recommendation of Food and Drug Administration to temporarily suspend New Regulatory Fees.

Malaysia: MDA Notification: Advisory on the Use of Malaria Test Kits

Thailand: The Implementation of the Electronic Certificate System (e-Certificate)

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Regulatory Updates

Regulatory Updates

Singapore: HSA Public Consultation Re: Proposed Exemption from Manufacturer’s Licensing and Product Registration Requirements for AI-SaMD in Public Healthcare

Thailand: Thai FDA Infographic Re: Document Supplementation System for Upgrading Submission Type from Partial (1 or 2) or Abridged to Full CSDT

Vietnam: Relocation of Infrastructure and Medical Device Administration

Philippines: Department of Health approves the recommendation of Food and Drug Administration to temporarily suspend New Regulatory Fees.

Malaysia: MDA Notification: Advisory on the Use of Malaria Test Kits

Thailand: The Implementation of the Electronic Certificate System (e-Certificate)

Countries

Categories

Sign up for our regulatory roundup delivered once a month to your inbox

Main Pages

Address

E-mail Address

Phone Number

Main Pages

Address

E-mail Address

Phone Number

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