Australian regulatory action on breast implants and breast tissue expanders

Australia – Medical devices reforms: Reclassification of certain medical devices

The TGA is considering certain devices and their current classification - particularly where there have been safety issues identified and/or where the European Union...
Hong Kong regulator will continue to recognize South Korean approvals

China – Medical device adverse event reports increase by 35% in China

China’s National Medical Products Administration (NMPA) has released new findings showing a substantial increase in the number of medical device adverse event reports for...
The Cosmetic Hygiene And Safety Act Reshaped Taiwan's Cosmetic Regulation

Taiwan – Taiwan update: Classification scheme, final fee schedule, post-market surveillance measures

Taiwan’s Medical Devices Act, which replaces the country’s former regulatory framework for medical devices, went into effect on May 1. But while the law is...
The Cosmetic Hygiene And Safety Act Reshaped Taiwan's Cosmetic Regulation

Taiwan – TFDA makes further announcements regarding new medical device regulations and fees

Following up on our earlier post providing details on Taiwan’s new medical device regulations, the following is a summary of noteworthy details that have subsequently become available....
Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard

Japan – Japan PMDA issues guidance on package insert digitization requirements

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a document (links in Japanese) explaining the updated requirements for package insert digitization. Starting on August 1,...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – India CDSCO delays regulation deadline for implantable medical devices

The Central Drugs Standard Control Organization (CDSCO), India’s medical device market regulator, has postponed deadlines for regulating implantable devices and other medical products for...

Vietnam – Vietnamese Ministry of Health proposes new decree for medical device regulation

The Vietnamese Ministry of Health (MoH) published a draft decree (download link, in Vietnamese) intended to replace Decree No. 36/2016/ND-CP​ and its amendments, which form the...
The Cosmetic Hygiene And Safety Act Reshaped Taiwan's Cosmetic Regulation

Taiwan – TFDA releases details about transition to new Taiwanese medical device regulations

Further details have begun to emerge about the new medical device regulations announced in Taiwan and slated to take effect on May 1. The Taiwan Food...
TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires

Australia – The regulation of medical device software, February 2021 : TGA presentation

These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the...

Asia – Asia-Pacific Roundup

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is going ahead with its planned changes to good manufacturing practices (GMPs) after receiving...

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