Although China’s medical regulatory bodies are becoming more harmonized with international standards, the Chinese registration process can still pose significant difficulties for Western medical device and pharmaceutical firms.
If you require assistance with obtaining approval for your medical device in China, Pacific Bridge Medical’s regulation compliance consultants can help you prepare the necessary documents and register you product with the Chinese regulatory authorities.
For more details regarding the regulatory requirements and registration process in China, click on the questions below.
Which regulatory bodies in the Chinese government are responsible for medical device registration in China?
- The China Food & Drug Administration (CFDA) is responsible for medical devices, drugs, and healthcare services. The organization is headquartered in Beijing, with offices in each province.
- The Center for Medical Device Evaluation (CMDE) is responsible for conducting the dossier review during the medical device registration process.
- The General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) conducts mandatory safety registration, certification, and inspection for certain devices.
In China, are medical devices required to be registered before they can be sold?
Yes, medical devices require CFDA registration prior to being sold in China.
What are the different regulatory classifications for medical devices?
- Class I Device: The safety and effectiveness of the device can be ensured through routine administration.
- Class II Device: Further control is required to ensure the safety and effectiveness of the device.
- Class III Device: The device is implanted into the human body; used for life support or sustenance; or pose potential risk to the human body, and thus must be strictly controlled in respect to safety and effectiveness.
What does the registration pathway look like for each regulatory classification?
Class I Device: Class I medical devices no longer need to be registered with the CFDA; instead, a notification must be filed with the relevant local level Chinese FDA. However, for the notification application, more documents will be required for Class I registration than before.
Class II & Class III Devices with No Clinical Trial Requirement:
- Chinese specification drafting (dossier preparation and specification drafting)
Timeframe: about 1 month
- Sample testing
Timeframe: about 6 months
- Filing to the CFDA (CFDA preliminary review and acceptance notice)
Timeframe: 1 month
- CMDE review; CMDE will issue a supplementary notice
Timeframe: 60-90 working days.
- Supplementary dossier preparation
Timeframe: maximum 1 year
- Further CMDE review
Timeframe: 60 working days
- CFDA final review and granting of the registration approval
Timeframe: 30 working days
Also note that clinical trials may be required for certain high-risk devices (e.g. implantable devices).
What are the document requirements for registration for each regulatory classification?
Class I Device
- Product Risk Analysis Document
- Product Technical Specification
- Product Testing Report (company’s self-testing report or 3rd party report)
- Clinical Evaluation Report
- Key Manufacturing Information (process, flowchart, material, etc.)
- Design/artwork of IFU and product label for the minimum selling unit
- Legal Documents
- Legal qualification of the foreign manufacturer (i.e. ISO 13485)
- Market authorization approval at the country of origin (i.e. CFG+510k or CE)
- Authorization letter to the agent in China.
- Self-declaration Letters
- Letter to declare that the documents submitted meets the CFDA’s regulation for Class I Medical device notification.
- Letter to declare that the product conforms to the Class I Medical Device classification catalog.
- Letter to declare that the product conforms to the National and/or Industry standards (GB/YY) in China, and the list of these conformed standards.
- Letter to declare that all submitted documents are true.
Please note that for all documents sent to the CFDA, the applicant should provide the Chinese translation as well. For the legal documents listed below, the applicant should submit the original or a notified copy.
Class II & Class III Device
A total of 12 document items must be collected and submitted to the CFDA, consisting of 9 legal documents, 2 technical documents, and a testing report issued by a CFDA certified testing center:
- Application Form
- Legal Documents
- Main Safety and Efficacy Specifications List
- Summary Data
- Product description
- Product model
- Description of the package
- Intended use and contraindications
- Predicated device (if applicable).
- Other information
- Research Data
- Product performance evaluation data
- Biocompatibility evaluation data
- Biosafety research data
- Sterilization and disinfection process validation data
- Shelf and package evaluation data
- Animal research data
- Software validation data
- Other data if necessary
- Manufacturing information
- Manufacturing process description for active/inactive device
- Manufacturing site description
- Clinical Evaluation Data
- Product Risk Analysis Data
- Product Technical Specifications
- Registration Testing Report
- Testing report issued by a CFDA certified lab
- Preliminary evaluation comment from the testing lab
- Artwork for the IFU and Product Label
- Instructions for use (IFU)
- Artwork of the product label for the minimum selling unit
- Self-declaration Documents
Is local testing (type testing/sample testing) required for registration?
In almost all situations for Class II and Class III devices, the CFDA will request samples for type testing. The testing centers will use the product standard to determine what tests to conduct.
- For Class II and Class III devices, the CFDA will request samples for type testing. For Class I products, CFDA will accept a company’s foreign report.
- Testing centers will test all specification items listed in the Product Technical Specifications (YZB Product Standard which is drafted by the company).
- For each specification item, testing centers will utilize the testing method described in the Product Technical Specifications.
- While conducting the tests, the CFDA requests that testing centers provide comments on the company’s drafted Product Technical Specifications.
- The comments from the testing center should be submitted together with the testing report to avoid repeats and additional testing, which occurs frequently, leading to long delays in the registration process.
The testing report will be issued by a CFDA certified testing center, which can be freely selected from the CFDA list. It is only valid for 1 year, and once it expires, a company must start again to obtain a new valid testing report.
When are clinical studies required for registration?
Clinical trials must be conducted for all Class II & III medical device registrations except in the following situations:
- The product has a clear working mechanism, finalized design, and mature production technology. A medical device of the same variety is already on the market and has been used in clinical practice for many years without any record of serious adverse events. There will also not be any changes to the product’s conventional usage.
- The safety and efficacy of the product can be proven through non-clinical evaluations.
- The safety and efficacy of the product can be proven through the analysis and evaluation of data obtained from clinical trials or clinical application of other medical devices of the same variety.
Is approval in the Country of Origin required for registration?
Yes, approval for the medical device in the Country of Origin is required before registration.
To discuss your specific needs in the Chinese healthcare market with a China medical device regulations expert, contact us today.
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