The guidelines of the registration for the manufacture of passive implantable bone, joint and oral hard tissue

On October 15th, the NMPA issued a notice on the guidelines for the technical review of the registration of medical devices for the manufacture of passive implantable bone, joint and oral hard tissue (No. 70 of 2019).

In order to better promote and standardize the innovative development of personalized additive manufacturing medical devices, and guide applicants to register the registration of personalized additive manufacturing medical device products, and at the same time, provide technical reference for the review of registration materials by the medical device supervision and management department, this guidelines are formulated.

Scope of application

1.This guiding principle is applicable to the manufacture of medical devices with personalized additive manufacturing that can be registered and managed, and the following elements should be met at the same time:

(1) Suitable for passive implantable medical devices for bone, joint and oral hard tissue;

(2) Personalized design is suitable for special disease conditions and / or adapt to special anatomical structures;

(3) All or part of the realization through the additive manufacturing process.

2. In the case of “customized medical devices”, it shall be managed in accordance with the “Regulations on the Supervision and Administration of Customized Medical Devices (Trial)”.

3. Any of the following, as all risks are not covered, only partial reference to the requirements of this guiding principle:

(1) Applicable to other medical devices other than bone, joint and oral hard tissue;

(2) Medical devices that meet the "individualized design" and / or "additive manufacturing process", but do not meet the "passive implantability";

(3) Specially designed medical devices such as biological 3D printing containing bioactive substances such as pharmaceutical ingredients, cells, and tissues.

Relevant standards applicable to products:

Including but not limited to the relevant standards listed in the table below (Note: the standard applies to the latest version of this guideline)