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)

 

Standard Number

Title of Standards

YY/T 0316-2016

Application of medical device risk management to medical device

ISO 17296-2:2015

Additive manufacturing -- General principles -- Part 2: Overview of process categories and feedstock

ISO 17296-3:2014

Additive manufacturing -- General principles -- Part 3: Main characteristics and corresponding test methods

ISO 17296-4:2014

Additive manufacturing -- General principles -- Part 4: Overview of data processing

ASTM F2924-12

Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion

ASTM F3001-14

Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4Vanadium ELIExtra Low Interstitialwith Powder Bed Fusion

ASTM F3091/F3091M-14

Standard Specification for Powder Bed Fusion of Plastic Materials

ASTM F3049-14

Standard Guide for Characterizing Properties of Metal Powders Used for Additive Manufacturing Processes

ISO/ASTM 52921:2013

Standard terminology for additive manufacturing -- Coordinate systems and test methodologies

ISO/ASTM 52915:2016

Specification for additive manufacturing file formatAMFVersion 1.2

ISO/ASTM 52901:2017

Additive manufacturing -- General principles -- Requirements for purchased AM parts

ISO/ASTM 52900:2015

Additive manufacturing -- General principles – Terminology

 

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