Overview

China is the fastest growing market for Medical Devices whose major share of device demand is met through exports. China Food and Drug Administration’s (CFDA’s) arm 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). Devices of Class II and III require clinical data post testing from CFDA accredited labs whose approval can take up to 2 years. Free Sale Certification from country of origin, ISO 13485 Certification and procurement of multiple obligatory documents set to be more roadblocks, slowing down the process amid time-bound situations.

Freyr prepares client for compliance to obtain various certifications and other documentation that leads to market approval within strict timelines. With knowledge on local Regulatory landscape, Freyr guides manufacturers in successful clinical testing and its study data compilation in manner prescribed by CFDA. We also offer local representation and a full-circle Regulatory services for medical device manufacturers.

 

China Market Entry for Medical Devices - Process Flow

China Medical Device Regulations

 

 

Freyr Expertise

  • Regulatory Assistance for Registration
  • Medical Device Classification
  • Clinical Trial Support
  • 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.