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3D Printed Medical Device Technical Review Guideline Outline



CFDA developed this document to provide guidance to industry and CFDA staff about current technical review for customize-designed additive manufactured (3D-printed) medical device.

I. Scope

The requirements in this guidance document cover customize-designed 3D-printed implantable passive medical devices related to bone, joint and tooth, but do not cover all the requirements for special designed biological 3D-printed medical devices that contain bioactive substances such as pharmaceutical ingredients, cells, tissues and etc.

Customize-designed 3D-printed active medical device and biological 3D-printed medical device could reference to some of the specific requirements in this document.

II. Registration Unit Classification

The proposed device registration unit classification shall be based on design, additive manufacturing method (material and process), intended use, and critical performance specification.

III.   Submission Documentation Requirements

The submission documentation shall include the following ite

1. Product Name

2. Product Description

3. Product Size

4. Product Intended Use and Contraindication

5. Product Comparison With Substantial Equivalent Predicate Devices

6. Product Performance Specification

6.1 Material Property

6.2 Product Structure and Mechanical Property

6.3 Biocompatibility Evaluation

6.4 Cleaning and Sterilization

6.5 Product Packaging and Expiration Date

6.6  Animal Test

6.6.1        Experimental Design Principle  Animal Model Selection  Experimental Grouping  Control Group Selection  Observation Period Selection  Outcome Measures Selection

6.6.2        Experimental Report Content  Experimental Purpose  Sample Selection Justification  Experimental Animal Information  Experimental Animal Model  Observation Period Selection  Sample Collection and Preparation  Experimental Result  Experimental Conclusion and Evaluation

7.  Doctor-Engineer Interaction Condition and Capability Validation

7.1  Interaction Condition Validation

7.1.1        Additive Manufacturing Equipment Verification and Validation  Equipment Software Verification  Equipment Hardware Verification  Equipment Program Validation

7.1.2        Additive Manufacturing Process Verification

7.1.3        Raw Material Verification

7.1.4        Post-processing Method and Verification

7.1.5        Sub-assemble and Finish Good Testing

7.2  Interaction Capability Validation

7.2.1        Design Control  Design Input  Design Verification  Design Validation  Design Change

7.2.2        Clinical Delivery Control

7.2.3        Clinical Usage Control

8.        Clinical Trial /Evaluation

8.1  Incomparable Device Condition

8.2  Comparable Device Condition

8.2.1        Clinical Trial Tester Selection Standard

8.2.2        Clinical Trial Exit-Tester Standard and Handling

8.2.3        Customize-designed Implementable Device Surgical Procedure Operation Requirement

8.2.4        Clinical Trial Testing Duration and Window Period

8.2.5        Clinical Trial Evaluation Index and Judgement Standard

8.2.6        Comparison Device Selection

8.2.7        Statistical Analysis

9.      Product Risk Assessment

10.    Product Technical Requirement

11.    Product Registration Inspection

12.    Product IFU & Minimum Sellable Unit Label Sample

IV. Reference Documents

V. Drafted Organization


About China Med Device, LLC

China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ western companies’ entry.

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