Chinese Food and Drug Administration (CFDA) Regulatory Approval Process: Medical Device Market Entry

Seth J. Goldenberg PhD

Senior Principal Scientist

NAMSA

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Overview Overview of Testing Process China Medical Device Standards Medical Devices Registration Changes

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Overview of Testing Process

Manufacturers must write standards and file for validation testing at CFDA designated sites

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Overview of Testing Process

Manufacturers must write standards and file for validation testing at CFDA designated sites

Careful following of existing testing standards

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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

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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

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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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China Medical Device Standards

Types of Standards GB – National Mandatory Standards

Typically follow global standards . . . Almost GB/T 16886 . . . ISO 10993

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China Medical Device Standards

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

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China Medical Device Standards

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

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China Medical Device Standards

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

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Medical Devices Registration Changes

Issued on March 31st, 2014, the CFDA regulation changes went into effect on June 1st, 2014.

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Medical Devices Registration Changes

Class I will no longer require registration, but will change to filing

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Medical Devices Registration Changes

Class I will no longer require registration, but will change to filing Risk analysis report of the product

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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

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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

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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

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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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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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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 effectiveness of the product

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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

effectiveness of the product The medical device registration applicant and filing

applicant shall be responsible for the authenticity of the submitted documents

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Clinical Trials

Class II and Class III have similar requirements for registration

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Clinical Trials

Class II and Class III have similar requirements for registration

Most significant change is the requirement for clinical trials

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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)

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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

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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

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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

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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

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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

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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

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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

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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

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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

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