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Medical Device Registration in China

With the fast-growing medical device market in China, an increasing number of foreign investors are watching this industry. In this White Paper, we introduce the current regulatory environment, investment vehicles and other relevant aspects for manufacturing, trading and importing medical devices in China.

The People’s Republic of China has probably already surpassed Japan to become the second largest medical device market in the world after the United States. It is estimated that the market for medical devices in China will shortly (if not already) account for more than 5 per cent of the world market for medical devices.

As the world’s most populous country and the fastest growing economy, China offers vast opportunities for investors in a medical device market that has shown strong growth in recent years. Although China’s medical regulatory bodies are becoming more harmonized with international standards, the Chinese registration process still poses significant difficulties for Western medical device and pharmaceutical firms.

If you require assistance with obtaining CFDA approval for your medical device in China, Corporation China’s regulation compliance consultants can help you prepare the necessary documents and register your product with the Chinese regulatory authorities.

For more details regarding the regulatory requirements and registration process in China, click on the questions below.

Supervision and administrative authorities responsible for medical device registration in China

In China, the State Food and Drug Administration (SFDA) supervises the medical device sector at the national level. In practice, the SFDA delegates a lot of administrative powers to its local branches. The food and drug administrations of the provinces, autonomous regions and municipalities directly under the central government (Local FDAs) are authorised to issue specific licenses and product registration certificates to medical device companies. One of the characteristics of the China market is that different local FDAs may have their own specific examination and approval requirements that go beyond national requirements.  

Classifications for medical devices

According to the definition provided in China’s medical device law, a medical device is a tool, apparatus, material or other good, including but not limited to software, that is independently or jointly used on the human body. In order to effectively supervise and manage the medical device market, the SFDA classifies various medical devices into three classes

Class I medical devices refer to those under routine administration for their safety and efficacy, such as rehabilitation techniques, disinfecting devices and apparatus.

Class II medical devices include those that must be controlled for their safety and efficacy, such as weak laser in-vitro treatment instruments, blood assay devices and apparatus.

Class III medical devices are those implanted into the human body, or used for life support or sustenance, and pose potential risk to human life, such as implanted artificial internal organs and infant care devices. Class III medical devices are those subject to the strictest controls for safety and efficacy.

Steps to get business liscence

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 than there were for Class I registration.

Class II & Class III Devices with No Clinical Trial Requirement:

Steps from 1 to 7

Time needed

Chinese specification drafting

1 month

Sample testing

6 months

Filing to the CFDA

1 month

CMDE review

60-90 working days

Supplementary dossier preparation

Not exceeding 1 year

Further CMDE review

60 working days

CFDA final review and granting of the registration approval

30 working days

Document requirements for registration

Class I Device

  1. Product Risk Analysis Document
  2. Product Technical Specification
  3. Product Testing Report (company’s self-testing report or 3rd party report)
  4. Clinical Evaluation Report
  5. Key Manufacturing Information (process, flowchart, material, etc.)
  6. Design/artwork of IFU and product label for the minimum selling unit
  7. 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.
  8. 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:

  1. Application Form
  2. Legal Documents
  3. Main Safety and Efficacy Specifications List
  4. Summary Data:
  5. Research Data:
  6. Manufacturing information:
  7. Clinical Evaluation Data
  8. Product Risk Analysis Data
  9. Product Technical Specifications
  10. Registration Testing Report:
  11. Artwork for the IFU and Product Label
  12. Self-declaration Documents

The time point of clinical studies required for registration

Clinical trials must be conducted for all Class II & III medical device registrations except in the following situations:

  1. 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.
  2. The safety and efficacy of the product can be proven through non-clinical evaluations.
  3. 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.

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