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