A New Draft Guideline on Additive Manufacturing Metallic Implants issued!

Your feedback counts! On September 6, 2021, NMPA’s CMDE published the Draft Guideline for Registration Review on Quality Uniformity of Additive Manufacturing Metal Implants for public comments. Any feedback needs to be submitted by October 8, 2021.

Additive manufacturing is what we called 3D printing. The quality uniformity of additive manufacturing metal implant refers to the consistency of the printing quality of metal implant products manufactured through additive process (including heat treatment and surface treatment).

The guideline provides the general requirements for the uniformity of product quality in the registration application of additive manufacturing metal implants. The applicant shall determine the applicability of various requirements in the guideline according to the specific characteristics of product (such as entity, porous, specific structure, etc.) and the actual clinical use. The applicant should further enrich and refine the relevant content of the application dossiers by fully considering the worst-case scenario for the product characteristics.

Scope of Application

This guideline applies to metal implants manufactured for patient-matched medical devices using powder bed fusion processes, including selective laser melting (SLM), electron beam melting (EBM).

Essential Requirements for Quality Uniformity

In the performance study, the applicant shall evaluate or compare the consistency of the following elements:

(I) Chemical composition

(II) Dimension

(III) Porous structure

(IV) Internal quality (defects, metal powder residue, etc.)

(V) Microscopic structure

(VI) Surface quality (surface defect, surface roughness)

(VII) Mechanical performance

(VIII) Corrosion resistance and metal ion precipitation

Process Requirements for Uniformity of Quality

In the performance study, the applicant shall elaborate the typical factors that may cause uneven quality in terms of the software, equipment, powder raw materials and additive manufacturing process as well as post-processing process and personnel used for additive manufacturing, and describe the influencing factors, possible risks and quality control indicators. The applicant shall specify the verified fluctuation range of values as well as clinical acceptability.

For more information about how to develop a feedback strategy or assistance in submitting your inputs, please contact info@inspirativemed.com.