The document summarizes China's regulatory approval process for medical devices. It outlines the testing process manufacturers must go through, including writing custom product standards and undergoing variable performance testing at CFDA-designated sites. Recent changes require Class I devices to file documentation rather than register, and Class II and III devices to conduct clinical trials for approval, with some exceptions. IVD registration requirements also changed, with Class I through filing, and Classes II and III requiring registration and trials.

1. Chinese Food and Drug Administration
(CFDA) Regulatory Approval Process:
Medical Device Market Entry
Seth J. Goldenberg PhD
Senior Principal Scientist
NAMSA

2. 2
Overview
 Overview of Testing Process
 China Medical Device Standards
 Medical Devices Registration Changes

3. Overview of Testing Process
 Manufacturers must write standards and file for
validation testing at CFDA designated sites
3

4. Overview of Testing Process
 Manufacturers must write standards and file for
validation testing at CFDA designated sites
 Careful following of existing testing standards
4

5. Overview of Testing Process
 Manufacturers must write standards and file for
validation testing at CFDA designated sites
 Careful following of existing testing standards
 The custom “product standards” will be generated
referencing current Industry (YY) and National (GB)
standards
5

6. Overview of Testing Process
 Manufacturers must write standards and file for
validation testing at CFDA designated sites
 Careful following of existing testing standards
 The custom “product standards” will be generated
referencing current Industry (YY) and National (GB)
standards
 Performance testing can be highly variable at
CFDA between test labs and between foreign test
results
6

7. Overview of Testing Process
 Manufacturers must write standards and file for
validation testing at CFDA designated sites
 Careful following of existing testing standards
 The custom “product standards” will be generated
referencing current Industry (YY) and National (GB)
standards
 Performance testing can be highly variable at
CFDA between test labs and between foreign test
results
 Sending a representative to testing lab is key
 Briefed on performance of device and functionality
7

8. China Medical Device Standards
8
 Types of Standards
 GB – National Mandatory Standards
 Typically follow global standards . . . Almost
 GB/T 16886 . . . ISO 10993

9. China Medical Device Standards
9
 Types of Standards
 GB – National Mandatory Standards
 Typically follow global standards . . . Almost
 GB/T 16886 . . . ISO 10993
 YY Standards – Industrial standards in Medical area
 Mandatory

10. China Medical Device Standards
10
 Types of Standards
 GB – National Mandatory Standards
 Typically follow global standards . . . Almost
 GB/T 16886 . . . ISO 10993
 YY Standards – Industrial standards in Medical area
 Mandatory
 YY/T standards – Industrial standards in Medical
area
 Recommended
 YY/T 0660-2008 vs. ASTM F2026-12
 PEEK for Surgical Implant Applications

11. China Medical Device Standards
11
 Types of Standards
 GB – National Mandatory Standards
 Typically follow global standards . . . Almost
 GB/T 16886 . . . ISO 10993
 YY Standards – Industrial standards in Medical area
 Mandatory
 YY/T standards – Industrial standards in Medical area
 Recommended
 YY/T 0660-2008 vs. ASTM F2026-12
 PEEK for Surgical Implant Applications
 YZB Registration Product Standards
 Baseline for testing for a given device
 Compiled by the device manufacturer to China Medical Device
Standards

12. Medical Devices Registration Changes
Issued on March 31st, 2014, the CFDA regulation
changes went into effect on June 1st, 2014.
12

13. Medical Devices Registration Changes
 Class I will no longer require registration, but will
13
change to filing

14. Medical Devices Registration Changes
 Class I will no longer require registration, but will
14
change to filing
 Risk analysis report of the product

15. Medical Devices Registration Changes
 Class I will no longer require registration, but will
change to filing
 Risk analysis report of the product
 Technical requirements of the product
15

16. Medical Devices Registration Changes
 Class I will no longer require registration, but will
change to filing
 Risk analysis report of the product
 Technical requirements of the product
 Testing report of the product
16

17. Medical Devices Registration Changes
 Class I will no longer require registration, but will
change to filing
 Risk analysis report of the product
 Technical requirements of the product
 Testing report of the product
 Clinical evaluation material
17

18. Medical Devices Registration Changes
 Class I will no longer require registration, but will
change to filing
 Risk analysis report of the product
 Technical requirements of the product
 Testing report of the product
 Clinical evaluation material
 Sample of Instruction for Use and label
18

19. Medical Devices Registration Changes
 Class I will no longer require registration, but will
change to filing
 Risk analysis report of the product
 Technical requirements of the product
 Testing report of the product
 Clinical evaluation material
 Sample of Instruction for Use and label
 Quality management system document related to
research and development and manufacture
19

20. Medical Devices Registration Changes
 Class I will no longer require registration, but will
change to filing
 Risk analysis report of the product
 Technical requirements of the product
 Testing report of the product
 Clinical evaluation material
 Sample of Instruction for Use and label
 Quality management system document related to
research and development and manufacture
 Other necessary documents to demonstrate safety
20
and effectiveness of the product

21. Medical Devices Registration Changes
 Class I will no longer require registration, but will
change to filing
 Risk analysis report of the product
 Technical requirements of the product
 Testing report of the product
 Clinical evaluation material
 Sample of Instruction for Use and label
 Quality management system document related to
research and development and manufacture
 Other necessary documents to demonstrate safety and
21
effectiveness of the product
 The medical device registration applicant and filing
applicant shall be responsible for the authenticity of the
submitted documents

22. 22
Clinical Trials
 Class II and Class III have similar requirements for
registration

23. 23
Clinical Trials
 Class II and Class III have similar requirements for
registration
 Most significant change is the requirement for
clinical trials

24. 24
Clinical Trials
 Class II and Class III have similar requirements for
registration
 Most significant change is the requirement for
clinical trials
 Class II and Class III medical device registration
will require clinical trials, with some exceptions
(over 500 products on approved exemption list)

25. 25
Clinical Trials
 Class II and Class III have similar requirements for
registration
 Most significant change is the requirement for
clinical trials
 Class II and Class III medical device registration
will require clinical trials, with some exceptions
(over 500 products on approved exemption list)
 Similar products have been on the market for years
without any adverse events

26. 26
Clinical Trials
 Class II and Class III have similar requirements for
registration
 Most significant change is the requirement for
clinical trials
 Class II and Class III medical device registration
will require clinical trials, with some exceptions
(over 500 products on approved exemption list)
 Similar products have been on the market for years
without any adverse events
 The safety and effectiveness of the medical device
can be proven through non-clinical evaluation

27. 27
Clinical Trials
 Class II and Class III have similar requirements for
registration
 Most significant change is the requirement for clinical
trials
 Class II and Class III medical device registration will
require clinical trials, with some exceptions (over 500
products on approved exemption list)
 Similar products have been on the market for years
without any adverse events
 The safety and effectiveness of the medical device
can be proven through non-clinical evaluation
 The safety and effectiveness of the medical device
can be demonstrated through the analysis and
evaluation of the data obtained from clinical trials or
clinical application of the substantially equivalent
medical devices

28. 28
IVD Registration
 Class I (i.e. microbe identification) IVD will be
through filing, II (i.e. diagnostics targeting proteins,
enzymes, etc.) and III (i.e. genetic tests, pathogens,
etc.) will require registration

29. 29
IVD Registration
 Class I (i.e. microbe identification) IVD will be
through filing, II (i.e. diagnostics targeting proteins,
enzymes, etc.) and III (i.e. genetic tests, pathogens,
etc.) will require registration
 Class III IVDs will undergo testing by the CFDA
prior to final approval
 Preference for products manufactured in Hong Kong,
Taiwan, or Macao with references to those countries
provisions and potential for waiver of China
regulations

30. 30
IVD Registration
 Class I (i.e. microbe identification) IVD will be
through filing, II (i.e. diagnostics targeting proteins,
enzymes, etc.) and III (i.e. genetic tests, pathogens,
etc.) will require registration
 Class III IVDs will undergo testing by the CFDA
prior to final approval
 Preference for products manufactured in Hong Kong,
Taiwan, or Macao with references to those countries
provisions and potential for waiver of China regulations
 Class III IVD trials will require at least 3 sites and
Class II IVD trials will require at least 2 sites

31. 31
IVD Registration
 Class I (i.e. microbe identification) IVD will be
through filing, II (i.e. diagnostics targeting proteins,
enzymes, etc.) and III (i.e. genetic tests, pathogens,
etc.) will require registration
 Class III IVDs will undergo testing by the CFDA
prior to final approval
 Preference for products manufactured in Hong Kong,
Taiwan, or Macao with references to those countries
provisions and potential for waiver of China regulations
 Class III IVD trials will require at least 3 sites and
Class II IVD trials will require at least 2 sites
 Waivers can be obtained for cases of rare diseases
or public health emergencies

32. 32
IVD Registration
 Class I (i.e. microbe identification) IVD will be
through filing, II (i.e. diagnostics targeting proteins,
enzymes, etc.) and III (i.e. genetic tests, pathogens,
etc.) will require registration
 Class III IVDs will undergo testing by the CFDA
prior to final approval
 Preference for products manufactured in Hong Kong,
Taiwan, or Macao with references to those countries
provisions and potential for waiver of China regulations
 Class III IVD trials will require at least 3 sites and
Class II IVD trials will require at least 2 sites
 Waivers can be obtained for cases of rare diseases
or public health emergencies
 Imported products must submit overseas clinical
trial data to support clinical trial application

33. 33
IVD Registration
 Class I (i.e. microbe identification) IVD will be through filing, II (i.e.
diagnostics targeting proteins, enzymes, etc.) and III (i.e. genetic tests,
pathogens, etc.) will require registration
 Class III IVDs will undergo testing by the CFDA prior to final approval
 Preference for products manufactured in Hong Kong, Taiwan, or Macao with
references to those countries provisions and potential for waiver of China
regulations
 Class III IVD trials will require at least 3 sites and Class II IVD trials will
require at least 2 sites
 Waivers can be obtained for cases of rare diseases or public health
emergencies
 Imported products must submit overseas clinical trial data to support
clinical trial application
 Any changes to supplier of main materials (i.e. antigen or antibody),
product instructions, packaging, production address, or any change
that could affect the product must be reported to the CFDA for review

34.  To view the complete Remote Training Series on Chinese
Food and Drug Administration Regulatory Approval Process
 Check out NAMSA’s Seminars
 For information about the Regulatory services NAMSA can
34
offer you
 Visit our Regulatory page
 For additional information
 Download our brochure on Regulatory and Quality
Systems Consulting
 Contact us at clientcare@namsa.com.