Overseas inspection of drugs and medical devices

China

On 26 December 2018, the National Medical Products Administration (“NMPA”) issued the Administrative Measures for Overseas Inspection Drugs and Medical Devices (“Measures”) effective as of 26 December 2018.

According to the Measures, the drugs and medical devices imported or to be imported in China shall be subject to the overseas inspection of NMPA. The inspection shall be made to the overseas process of development and production of these drugs and medical devices. The purpose of the inspection is to ensure the authenticity, reliability and compliance of these aforesaid processes of development and production. The article summarizes the key aspects of measures.

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