China NMPA Guidance on Self-Testing of Medical Devices for Registration

Following the implementation of Order 739 on June 1st, 2021, the China NMPA issued draft guidance on the Self-testing of Medical Devices for Registration. The draft is released to the public for opinions, with a deadline of June 20th, 2021.

Order 739 exempts the previously mandatory in-country type testing requirements for overseas manufacturers. Self-testing reports, including third-party testing issued by qualified laboratories and institutions and meeting NMPA requirements, can be accepted for registration submission moving forward.

The draft guidance includes the following sections:

• Requirements for the self-testing report
• Requirements for third-party testing, including qualifications, evaluation of the third-party laboratory, and sample consistency
• Related documents added to the registration dossier
• Requirements for on-site inspection

Contact us for:

• More information about Order 739 & Self-testing requirements
• Self-testing qualification evaluation
• Self-testing report gap analysis
• Product technical requirements (PTR) gap analysis
• Training

For an English copy of Order 739,or the draft guidance on the Self-testing of Medical Devices for Registration,please  email to info@inspirativemed.com