Seegene's COVID-19 test authorized for emergency use in Korea

South Korea – South Korea updates regulations on medical device codes and classification

The Ministry of Food and Drug Safety (MFDS), South Korea’s medical device market regulator, issued a draft revision to Regulations on Medical Device Codes...
Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard

Japan – Japan’s medical device regulators update PMD Act and the online submissions process

Japan’s medical device regulators have updated processes and procedures that manufacturers and suppliers must comply with in order to obtain Japanese market access. These...
Home-grown colorectal cancer drug approved in China

China – Medical device regulators revise Clinical Trial Quality Management Regulation and various device-specific...

Several new guidelines have been announced by medical device market regulators in China. First, the Chinese National Medical Product Administration (NMPA) released updates regarding rules...

Australia – Process chart: Australia TGA regulatory approval for medical devices

Australia’s medical device market regulator has issued new guidance on digital mental health device regulation. The Therapeutic Goods Administration (TGA) published the fact sheet to inform...

India – India’s medical device regulators adopt amendment regarding cancellation and suspension of licenses

If you are a medical device manufacturer or supplier you will want to make sure to comply with the latest rules in order to...

Australia – Update: TGA defines which digital mental health software it regulates

Australia’s medical device market regulator has issued new guidance on digital mental health device regulation. The Therapeutic Goods Administration (TGA) published the fact sheet to inform...
Singapore HSA revises guidance and technical documents

Singapore – Singapore issues new guidance for software as a medical device

As software has begun to have an increasingly important role in many medical devices that rely on it for safe and effective function, Singapore’s...
CORONAVIRUS : India halts exports of about 2 dozen APIs, drugs

India – India’s DCGI adds more medical device testing laboratories

Helping to make getting your medical device or in vitro diagnostic (IVD) device testing done a little bit easier, the Drug Controller General of...
TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires

Australia – TGA publishes latest medical device application processing times

Australia’s Therapeutic Goods Administration (TGA) has published Medical device application processing times, which provides details on its latest timelines for medical device and in vitro diagnostic (IVD)...
TGA Clears Pharmacies to Advertise Salbutamol Inhalers During Fires

Australia – TGA expectations for transition to 2021 Advertising Code and updated guidance on...

The TGA released its guidance on Transitioning to the new Therapeutic Goods Advertising Code last week. In it, the TGA clarified its expectations for medical device...

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