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China Moves From Administrative Orders To Medtech Law – Consultation Underway

Adherence To Chinese Standards Accentuated In Law That Could Be In Place In 2025

 
• By Ashley Yeo

After high-level deliberations, a draft Medical Device Administration Law to supersede the series of medical devices administrative orders has been issued by the Chinese State Food and Drug Administration. A stakeholder consultation is underway.

Flags of China flying in Shanghai

Comments from medtech stakeholders in all geographies are invited until 28 September on the Chinese State Food and Drug Administration’s draft Medical Device Administration Law (MDAL). The law is set to replace the medical devices supervision and administration regulation issued since 2000, most recently No. 739 in 2021.

It would be China’s first national level law governing medical devices. The MDAL would have purview over the total medical...

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