Pathways' Pick of the Week: China Unveils New Manufacturing and Quality Measures

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Device developers who want to work with Chinese manufacturers have new flexibilities, but also face steeper responsibilities. From Pathways' Pick of the Week, March 23, 2022.

New flexibilities for device developers to contract with manufacturers to make products in China and steeper responsibilities for companies to maintain control of production and quality systems for their devices are spelled out in new administrative measures document issued by the National Medical Products Administration. The measures are intended to implement some of the broad-based reforms that took effect last June in China. Measures addressing device “production” issued March 22 detail new allowances for device firms to work with “entrusted manufacturers” for their products, and the new expectations and enforcement mechanisms to ensure quality is maintained. A document issued the same day focused on device “operation measures” discusses quality management and self-inspection requirements for entities that make and sell devices. (Links in Simplified Chinese.) The provisions outlined in the documents technically come into force on May 1.

Excerpted from Pathways’ Picks March 23: Next Picks in Europe and the US, China Measures, And More,” Market Pathways, March 23, 2022.

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