China’s CMDE Announces New Regulations on the Supervision and Administration of Customized Medical Devices for Clinical Trials

The Center of Medical Device Evolution (CMDE) of China has released a regulation (notification 53) that clarifies the requirements for the definition, listing, design, processing, usage, supervision and management of Customized medical devices.

Definition of Customized Medical Devices:

According to the article 31 of the notification 53 stated that personalized medical devices can be divided into:

1. Customized medical devices (CMD) are devices that are designed and produced according to suitable provisions based upon the clinical needs of a specific patient group as determined by the physician. These devices are specifically catered for rare conditions. Personalized medical devices are expected to improve the diagnostic performance and treatment efficacy.
2. Patient matching medical device (PMMD), are devices designed and produced for a particular patient by a medical device manufacturer through a proven process based on standard provisions for mass production of medical devices, in accordance with the clinical demands.

The medical device manufacturers and the medical institutions can together act as license holders of customized devices. The regulation has set clear requirements in order to properly mitigate risks associated with the use of such devices.

Regulatory Requirements for Submission of Customized Medical Devices:

• Customized device application form
• Declaration for necessity of production and use of customized device
• Relevant product research materials
• Product risk analysis data
• Manufacturing information
• Clinical application plan
• Opinion of Ethics committee
• Agreement between Contract of manufacturer with medical institution
• Administrative information
• Declaration of conformity

The Regulation shall also mention the following points:

• 3D printing device would be validated and controlled in various aspects: production and verification processes, manufacturing process, post-treatment, testing of raw materials and final products, as well as cleaning, packaging and sterilization.
• The qualification of medical institution for conducting surgery must be approved by NMPA.
• Before using device, clinician, patient, and manufacturer need to sign three-party contract.
• Non-replaceable device which qualified subjects are rare, cohort research with 10-20 subjects could be conducted, with a comprehensive analysis with historical data.