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Singapore

Singapore: HSA Introduces Change Management Program (CMP) for SaMD, Including Machine-Learning Enabled SaMD

January 16, 2025

Regulatory Affairs Update: Singapore

Singapore: Guidance for Good Submission Practice

October 7, 2024

Regulatory affairs update: Singapore

Singapore: Consultation on draft of Guidance on Change Management Program (CMP) for SaMD

September 4, 2024

Regulatory Affairs Update: Singapore

Singapore: NextGen MD Initiative

July 1, 2024

Regulatory Affairs Update: Singapore

Singapore: HSA’s Registration Approvals Recognised by Hong Kong MDD for Class II / III / IV Listing in Hong Kong

May 14, 2024

Andaman Medical Regulatory Affairs Update: Singapore

Singapore: Updates To Cybersecurity Labelling Scheme For Medical Devices [CLS(MD)] Sandbox

April 24, 2024

Regulatory Affairs Update: Vietnam

Vietnam: Decision on the Criteria and Principles for the ASEAN CSDT Assessment of Non-In Vitro and In-Vitro Medical Devices

April 3, 2024

Andaman Medical Regulatory Affairs Update Singapore

Singapore: HSA Regulations Alignment Related With Software / Programmed or Programmable Medical Device

March 26, 2024

Andaman Regulatory Affairs Update Singapore

Singapore: New Revision of the Medical Devices Product Classification Guide

February 19, 2024

Singapore: Announcement on the List of Regulatory Fee Revision for Health Products

January 17, 2024

closeup photo of eyeglasses

Singapore: HSA Warns On Cybersecurity Vulnerabilities Potentially Affecting Medical Devices Using 5G Modems

January 3, 2024

Person at desk with files and binders

Singapore: HSA Shares Revisions on Change Notification Guidelines Following EU MDR and IVDR Changes

December 13, 2023

Hand tapping a sign labelled feedback

Singapore: Public Comments on Revised Draft of GN-20: Guidance on Clinical Evaluation

November 8, 2023

Singapore: New Revision of the Medical Devices Product Classification Guide

November 1, 2023

Singapore: HSA Published List of Standards for Medical Devices

September 22, 2023

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ANDAMAN MEDICAL PTE LTD (Registration no. 201524804D)
(Head Office Singapore)
Tampines Junction Business Center
Level 09-02 300 Tampines Avenue 5, Singapore 529653

ANDAMAN MEDICAL PTE LTD
(Registration no. 201524804D)
(Head Office Singapore)
Tampines Junction Business Center Level
09-02, 300 Tampines Avenue 5, Singapore 529653

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sales@andamanmed.com

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Welcome to Andaman Medical. We are your trusted partner for regulatory affairs and market access in Southeast Asia.

Whether you are a medical device manufacturer or distributor, our dedicated team is here to help you navigate the complex regulatory landscape and bring your products to market efficiently and compliantly.

Main Pages

Home
About Us
Services
Contact Us

Address

ANDAMAN MEDICAL PTE LTD (Registration no. 201524804D)
(Head Office Singapore)
Tampines Junction Business Center
Level 09-02 300 Tampines Avenue 5, Singapore 529653

ANDAMAN MEDICAL PTE LTD
(Registration no. 201524804D)
(Head Office Singapore)
Tampines Junction Business Center Level
09-02, 300 Tampines Avenue 5, Singapore 529653

E-mail Address

sales@andamanmed.com

Phone Number

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