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Regulatory Updates

Vietnam: Survey and Gathering Feedback for the Draft of Medical Device Law

October 22, 2024

Thailand: Guidelines for Attaching Medical Device Labels

October 22, 2024

Indonesia regulatory update

Indonesia: Issuance of Regulation Governing Telecommunications Equipment and Devices Testing Centres

October 18, 2024

Regulatory Affairs Update: Thailand

Thailand: FDA Infographic Announced the Process Involving Approved Licenses (Refer and Transfer)

October 9, 2024

Regulatory Affairs Update: Thailand

Thailand: FDA Infographic Announced the Format Change of Consent Form for the Reliance Program

October 9, 2024

Regulatory Affairs Update: Thailand

Thailand: Classifying Wound Dressing Products as Medical Devices

October 7, 2024

Regulatory Affairs Update: Thailand

Thailand: Thai FDA Infographic Shares the Process Regarding Renewal, Termination and Non-Renewal of Several Thai FDA Licenses

October 7, 2024

Regulatory Affairs Update: Vietnam

Vietnam: Handling of Unapproved Medical Devices Import Application Submitted Before 2022

October 7, 2024

Regulatory Affairs Update: Singapore

Singapore: Guidance for Good Submission Practice

October 7, 2024

Regulatory Affairs Update: Thailand

Thailand: Ministry of Public Health Notification, RE: Medical Devices that Must Display Shelf-life, Warnings, Contraindications, or Precautions on Labels or Instruction for Use (No.3) B.E. 2567 (2024)

October 2, 2024

Regulatory Affairs Update: Thailand

Thailand: Ministry of Public Health Notification, RE: Medical Devices to be Sold Only to Health Care Unit or Medical Practitioner and Public Health Professionals (No. 2) B.E. 2567 (2024)

October 2, 2024

Regulatory Affairs Update: Thailand

Thailand: Ministry of Public Health Notification, RE: Standards for Medical Devices that Local Manufacturers or Importers Must Comply With (No. 4) B.E. 2567 (2024)

October 2, 2024

Regulatory Affairs Update: Thailand

Thailand: Guidelines for Referencing Existing documents, Document transfer, or other cases in Submitting Applications to Manufacture and Import Licensed and Notified Medical Devices without requirements of Evaluation by Experts, Government Agencies, Organizations designated by Thai Food and Drug Administration B.E. 2567 (2024)

October 2, 2024

Regulatory Affairs Update: Thailand

Thailand: Cancellation of the Announcement Related to the Diagnostic Test Kits and Reagents for SARS-CoV-2 B.E. 2567 (2024)

September 26, 2024

Regulatory Affairs Update: Thailand

Thailand: Control Measures Adjustments for Diagnostic Test Kits and Reagents for COVID-19

September 26, 2024

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ANDAMAN MEDICAL PTE LTD (Registration no. 201524804D)
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ANDAMAN MEDICAL PTE LTD
(Registration no. 201524804D)
(Head Office Singapore)
Tampines Junction Business Center Level
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