Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medical Device Market Entry
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
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8. China Medical Device Standards
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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.
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13. Medical Devices Registration Changes
Class I will no longer require registration, but will
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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
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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
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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
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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
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34
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