A list of recently published and updated articles regarding medical device regulatory updates from the governing bodies throughout Asia.

Thailand FDA Provides Guidance on Classification of Physical Therapy Devices

/in , /by

On December 3rd, 2022, the Thailand FDA (TFDA) issued new regulation to re-classify Physical Therapy Devices as Class 1 medical devices.

Read more

Korea MFDS Implements Medical Device Monthly Reporting Requirements

/in , /by

The Korean MFDS now requires all Class II, III, and IV medical devices submit monthly installation reports via an online portal.

Read more

Singapore’s HSA Removes Classification and Grouping Inquiry Option

/in , /by

Beginning in 2022, the HSA has cease to entertain inquiries seeking confirmation of manufacturers’ classification and grouping strategy and has referred companies to their online tools and guidance documents.

Read more

Philippines FDA to Implement New Guidelines to Respond to Future National Health Emergencies

/in , /by

The Philippines FDA has issued a new report entitled “Guidelines on the Food and Drug Administration’s Regulatory Responses During Declared National or State Public Health Emergencies.”

Read more

Philippines FDA Issues Advisory Reiteration Against Unethical Business Practices

/in , /by

On December 29th, 2022 the Philippines FDA (PFDA) issued an advisory reiteration concerning unethical business practices, specifically in regards to companies that sell/manufacture Prescription Pharmaceutical Products and Medical Devices (PPPMD) and their relationship/interaction with healthcare professionals (HCPs).

Read more

Singapore’s HSA Issues New Software as Medical Device (SAMD) Guidance

/in , /by

In April 2022, Singapore’s Health Science Authority (HSA) issued new guidance for registering software as a medical device (SAMD) and Clinical Decision Support Software (CDSS) in Singapore.

Read more

Identifying Predicate Devices in India, Taiwan, China, Japan, and Korea

/in , , , , , , /by

An outline of the best practices for five different Asian countries that provide an abbreviated “predicate” registration route.

Read more

Hong Kong Refines Medical Device Post-Market Surveillance Report Form

/in , /by

On December 29th, 2022, the Hong Kong Medical Device Division refined and updated their Post-Market Surveillance Report form.

Read more

An Introduction to GeM, India’s Online Portal for All Public Hospital Purchases  

/in , /by

In 2016 the Indian government launched an online portal, the Government e-Marketplace (commonly referred to as GeM) under the Ministry of Commerce and Industry to provide for efficient and transparent procurement by government agencies across the country.

Read more

Bangladesh LAUNCHES NEW MEDICAL DEVICE REGULATIONS

/in , /by

On September 18, 2023, The Directorate General of Drug Administration (DGDA) published the Drug and Cosmetics Act 2023 formalizing the regulatory requirements of medical and diagnostic devices in Bangladesh with immediate effect.  A translated version of the document is available on Asia Actual’s website here.  All medical devices now require a Marketing Authorization Certificate to clear Customs and be sold on the market in Bangladesh.

Read more