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NMPA Announcement on Issuing the Guidance for Preparation of Contract Production Quality Agreement of Medical Devices

CCFDIE| Updated: 2022-03-24

In order to strengthen the supervision over medical device production, guarantee the safety and effectiveness of medical devices, and guide registrants, filing entities and contract manufacturers of medical devices to jointly manage the quality of contract manufacturing of medical devices, according to Paragraph 2 of Article 34 in the Regulations on Supervision and Administration of Medical Devices, the National Medical Products Administration organized to revise the Guidance for Preparation of Contract Manufacturing Quality Agreement of Medical Devices, which was issued on March 22, 2022.