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 items:
- Product Name
- Product Description
- Product Size
- Product Intended Use and Contraindication
- Product Comparison With Substantial Equivalent Predicate Device
- 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
6.6.1.1 Animal Model Selection
6.6.1.2 Experimental Grouping
6.6.1.3 Control Group Selection
6.6.1.4 Observation Period Selection
6.6.1.5 Outcome Measures Selection
6.6.2 Experimental Report Content
6.6.2.1 Experimental Purpose
6.6.2.2 Sample Selection Justification
6.6.2.3 Experimental Animal Information
6.6.2.4 Experimental Animal Model
6.6.2.5 Observation Period Selection
6.6.2.6 Sample Collection and Preparation
6.6.2.7 Experimental Result
6.6.2.8 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
7.1.1.1 Equipment Software Verification
7.1.1.2 Equipment Hardware Verification
7.1.1.3 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
7.2.1.1 Design Input
7.2.1.2 Design Verification
7.2.1.3 Design Validation
7.2.1.4 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
Technical Review Guideline of Medical Device Registration for Customized
Additive Manufacturing
(Feedback Draft)
Preface
The guideline is intended to encourage the innovation and development of medical device, provide technical guidance for the registration of medical device for customized additive
manufacturing (or “3D printing” for short), and offer technical reference for the food and drug
supervision and administration departments on registration materials review. This guideline is the general requirements of medical device product registration materials
for customized additive manufacturing, and the applicant shall specify the registration materials
according to the specific characteristics of the product and determine whether the specific
content is applicable or not according to the features of specific product. This guideline is the guiding document for the applicant and the reviewer, but excludes the
administrative matters involved in the registration and approval. It is not mandatory regulation.
If there are other methods that can meet the relevant regulatory requirements, it may also be
adopted, but detailed research data and verification data are required. This guideline shall be
used in accordance with relevant regulations and standards. This guideline is formulated under the current laws, regulations, standard systems and
knowledge levels. With the constant improvement of laws, regulations and standards as well as
the continuous development of science and technology, the related content of the guideline
will also be adjusted timely. I. Application scope
This guiding principle applies to the following situations:
Put forward by clinicians, customized design is applicable to the special disease condition
and/or special anatomical structure, which is a medical device through the additive
manufacturing technology, in order to satisfy the clinical need difficult to be solved by existing
standardized medical device or better meet special clinical requirements. This guiding principle covers skeletal, joint and dental passive implantable medical devices. This guiding principle is unable to cover all requirements of medical devices with special design
such as 3D bio-printing of biological active substances with drug ingredients, cells and tissues, but the applicable specific requirements can be taken as a reference. The passive nonimplantable medical device of customized additive manufacturing can refer to the applicable
specific requirements. II. Classification principle of registration unit
The products with different design methods of the main components of registered
product, additive manufacturing methods (material and process), application scopes and key
performance indicators shall be divided into different registration units. Othercircumstances
may refer to the relevant requirements of the Classification Guidelines of Medical Device
Registration Units and the guiding principles of product technical review. III. Registration Application Materialsrequirements
(i) Product name
According to the Classification Rules of Medical Device, General Naming Rules of Medical
Device and other relevant documents as well as the design characteristics and applicable scope
of registered product, its management category, classification code and normative naming
(product name and component name) are determined to discuss its determination basis. (ii) Product description
To describe the chemical compositions and proportions of raw materials for each
component of the product. To describe the product structure and its characteristics, discuss the rationality of
structure and form design, and provide illustrations. To describe the connection relation between product interface structure and human
tissues.(iii) Model specifications
To describe the relevant clinical dimension parameters, structural features, size range
(maximum and minimum) and tolerance, and specify the classification principle of model
specifications. (iv) Intended use and contraindication
To describe the specific use parts of the product, applicable population, use situation
