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Singapore

Singapore: HSA Safety Monitoring and GDPMDS Guidance Documents Update

September 22, 2023

updated stamp in business office showing update concept

Singapore: HSA Updated Medical Device Product Registration Guidance Documents and Related Templates

August 21, 2023

Singapore: Fifth Revision of Singapore’s Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices

August 14, 2023

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Singapore: The HSA Recognized By WHO As Stringent Regulatory Authority (SRA) For High-Risk In Vitro Diagnostic Medical Devices (IVDs)

June 27, 2023

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Singapore: Draft for Comments on GN-14: Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices Revision 3

May 10, 2023

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Singapore: HSA has been recognized as a comparable overseas regulator for medical devices by the TGA

March 28, 2023

Hand with stamp Update on paper

Singapore: Fifth Revision of GN-21: Guidance On Change Notification For Registered Medical Devices

March 13, 2023

Cyber security analyst working on a laptop

Singapore: Announcement: Public Consultation For The Proposed Framework And Implementation Of The Cybersecurity Labelling Scheme For Medical Devices, CLS (MD)

February 22, 2023

Notepad entitled 'policies update'

Singapore: Fourth Revision Of GN-35: Guidance On Special Access Routes (SAR)

January 11, 2023

Clinical trial injection bottle and hypodermic needle

Singapore: GN-20: Guidance on Clinical Evaluation Revision 2

November 24, 2022

Updates

Singapore: Minor Update on GN-06: Guidance on Distribution Records

November 14, 2022

New certification

Singapore: GN-33: Guidance on the Application of Singapore Standard Good Distribution Practice for Medical Devices

November 13, 2022

Minor update

Singapore: Minor Update on HSA Guidance on Labelling for Medical Devices

October 13, 2022

Exhibition with delegates visiting booths

Singapore: Minor Update To Guidance For Importation Of Unregistered Medical Devices For Exhibition In Singapore

September 9, 2022

Laboratory test using test tubes / in-vitro devices (IVD)

Singapore: HSA Released Draft Regulatory Guidelines for Laboratory Developed Tests (LDTs)

July 18, 2022

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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.

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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

E-mail Address

sales@andamanmed.com

Phone Number

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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