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Asia Pacific

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China Joins International Post-Market Surveillance Program

China’s National Medical Products Administration says that participating in the International Medical Device Regulators Forum’s program will help it control the risks associated with imported products.

China Safety Post Market Regulation & Studies
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Hong Kong Tests Acceptance Of South Korean Device Approvals

A new trial in Hong Kong applies to class II, III and IV medical devices that are already approved by South Korea’s Ministry of Food and Drug Safety.

Approvals Hong Kong

India Lists Product Testing Labs And Strengthens Guidance Offering

New notices from the Indian regulator list the laboratories designated to test medical devices or IVDs.

India Regulation

Global Medtech Guidance Tracker: September 2019

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-five guidance documents have been posted on the tracker since its last update.

Guidance Documents Regulation

Australia Suspends Breast Implants Over Cancer Risk Fears

The Therapeutic Goods Administration has now decided to take regulatory action on breast implants and tissue expanders following its review into the link between these products and a rare type of cancer.

Recalls Safety

Australia Reviews Ban On Many Self-Testing IVDs

A new public consultation is looking at whether Australia’s rules prohibiting the supply of many types of self-testing IVDs are still fit for purpose.

In Vitro Diagnostics Australia

China Widens MAH Scheme To Medtech As Consumables Face Price Cuts

China is quickly expanding its marketing authorization holder scheme from drugs to devices. It is also vowing to reduce medical costs by using more low-cost, domestic consumables, which will have a significant impact on companies.

Regulation Medical Device
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