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Regulatory Updates

Draft guidelines categorization of borderline health products FDA Philippines

FDA Philippines issues draft guideline on categorization of borderline health products

January 25, 2022

in vitro diagnostic draft regulation fda philippines

FDA Philippines issues draft regulation on IVD market authorizations

January 25, 2022

Philippines FDA allows registration Covid19 Self Test Kits

Philippines FDA opens registration to COVID19 Self-Test Kits

January 18, 2022

Restrictions online selling optical devices and contact lenses in Malaysia

Restrictions for the selling of Optical Devices and Contact Lenses online in Malaysia

January 17, 2022

Covid 19 Test Kit Philippines Validity Extension

COVID-19 Test Kit in the Philippines: ‘authorization validity’ extension

January 17, 2022

Medical device cyber security alert apache log4j

Medical Device cyber security vulnerability: Apache-Log4j

December 27, 2021

Philippines FDA medical device authorizations during public health emergency

Philippines FDA medical device authorizations during state of emergency

December 27, 2021

Vietnam product labeling new regulation

Vietnam issues new regulation for product labeling

December 21, 2021

Product classification medical device singapore

Medical Device Product Classification Guidance for Singapore

December 10, 2021

Vietnam issues new regulation for medical device management

Vietnam issues new regulation for medical device management

December 1, 2021

Abridged registration in the philippines

Abridged registration process for ASEAN registered medical devices in the Philippines

November 30, 2021

Malaysia requirements for supplying Covid-19 self test kits

Requirements For Supplying Covid-19 Rapid Self-Test Kits In Malaysia

November 23, 2021

Vietnam draft Decree on medical device management

Vietnam draft Decree to unify and simplify regulations on the management of medical devices and equipment.

November 4, 2021

Singapore publishes Artificial Intelligence in Healthcare guidelines

Singapore publishes Artificial Intelligence in Healthcare Guidelines (AIHGIe)

November 3, 2021

Malaysia conditional permission COVD19 self-test kits

Conditional permission for the import & distribution of Covid-19 self-test kits into Malaysia

November 2, 2021

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ANDAMAN MEDICAL PTE LTD (Registration no. 201524804D)
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Tampines Junction Business Center
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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

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