Overview

China is one of the fastest growing markets for Medical Devices where the demand for devices is majorly met through exports. China Food and Drug Administration’s (CFDA’s) Centre for Medical Device Evaluation (CMDE) is responsible for the review of the medical device import registration applications of all 3 classes of devices (Class I, II & III). Class II and III devices require clinical data from CFDA accredited labs whose approval can take up to 2 years. In addition, Free Sale Certification from country of origin, ISO 13485 Certification and procurement of multiple obligatory documents set to be more roadblocks, which may slow down the market entry process amid time-bound situations.

Freyr supports client to obtain various certifications and to compile other documentation that leads to market approval within strict timelines. With clear-cut knowledge on local Regulatory landscape, Freyr guides manufacturers in successful clinical testing and the study data compilation as regulated by the CFDA. 

China Market Entry for Medical Devices - Process Flow

China Medical Device Regulations

 

Freyr Expertise

  • Medical Device Classification
  • Quality Maintenance
    • FDA and CFDA Inspection Preparation
    • ISO 13485 Quality Management System (QMS) Audit and Gap Analysis
    • ISO 13485 QMS Implementation and Monitoring
    • ISO 13485 QMS Training
    • QMS Standard Operating Procedure (SOP) Writing and Implementation
    • Quality Manual Writing
    • Local Product Release
  • Clinical Trial Support
    • CRO Oversight and Management
    • Clinical Trial Application (CTA)
    • Clinical Trials for Medical Devices and IVD
    • Pre-clinical Investigation of Medical Devices
    • Clinical Trial Protocol Design and Writing
    • Clinical Trial Auditing and Quality Assurance
    • Data Management and Statistical Analysis
    • Clinical Studies Report Writing
    • ICC (In-country Care-taker)
  • Regulatory Assistance for Registration and Market Access
    • Market-access, Pricing, Reimbursement Strategies
    • Due-diligence and Asset Evaluation
    • Evidence-based Portfolio Prioritization
    • Review of Target Product Profile (TPP) and Label Claims
    • Economic Needs Assessment and Evaluation
    • Distributor Selection
    • Commercial and Marketing Strategies
  • Chinese Local Agent Representation
  • Testing Data and Dossier/Documents Compilation
  • Assistance for Listing Product Technical Specifications
  • Linguistic Translation Support for All Submission Documents
  • Post-market Surveillance 

Summary

S. No

Regulatory Parameter

China

1

Regulatory Authority

CFDA

2

Regulation

State Council Order No.650

3

Risk Classification

Class I

Class II

Class III

4

Regulatory Pathway

Class I

Notification

Class II & III

Registration

5

Authorized Representative

China Agent required

6

Fee payable

Class I

No Fee

Class II

~ $34,000*

Class III

~ $ 48,000*

7

QMS Requirement

YY/T0287-2017

ISO 13485

8

Assessment of Technical Data

Center for Medical Device Evaluation (CMDE)

9

Validity of License

Class I

Unlimited

 

 

Class II & III

5 Years

10

Labelling Requirements

Decree No.6 of CFDA

11

Submission format

Paper

12

Final Outcome

Class I

Notification

 

 

Class II & III

Registration Certificate

13

Timelines

Class I

3 -6 months

 

 

Class II

1 - 2 years

 

 

Class III

More than 2 years

14

Language

English & Chinese

*The price is as per records at the time of documentation and is subject to change.