It’s settled! The official draft of the two guiding principles released!

Recently, CMDE issues two official drafts of guiding principles. The following are the scope of application:

I .  Guidelines for Research on Uniformity of Physical Properties of Metal Implants in Additive Manufacturing

Scope of application

These guidelines apply to metal implants for patient matching medical devices using powder bed melting processes, including selective laser melting (SLM) and electron beam melting (EBM). Other additive manufacturing processes and customized medical devices are not within the scope of this guiding principle, but relevant products or situations can refer to the applicable parts of this guiding principle.

II.Guidelines for Registration Review of Additively Manufactured Polyetheretherketone Implants

 Scope of application

 This guiding principle is applicable to passive implantable medical devices that are made of PEEK material through additive manufacturing process and act on bones, joints and oral hard tissues. Implantable products made of composite additive with PEEK as the main body can refer to the applicable part of this guiding principle.

BradyKnows can provide manufacturers with all kinds of standardized consultation and standardized training services. Please do not hesitate to contact us at  info@bradyknowsmedical.com, if you have any question in the gap between your products and NMPA’s standards.