Tips on medical device registration under new CFDA regulations

China Food and Drug Administration (CFDA) have implemented the new medical device regulations with new submission and approval processes from October 1^st 2014. Foreign device manufacturer need to prepare the new regulatory compliance strategy to register your medical device product in China. To comply with the new CFDA regulations, the important tips about import medical devices registration in China should be followed:

1. Devices design and research (pre-market)

1. Make sure if your product managed as medical device or IVDs in China. It has extended its managing scope in the new medical device regulations, and CFDA may designate some product managed as medical device due to its higher risk.
2. Chinese generic name of medical device shall be normalized according to the new “Rules for Medical Device Nomenclature (interim)”, which is drafted corresponding to the international standard and Global Medical Device Nomenclature (GMDN) and will be implemented sooner or later.
3. Determine the classification for your medical device or IVD product according to the new “Catalogue of medical device classification” and the “Provisions for medical device classification”, CFDA will supplement and update the associated catalogue frequently, some device’s classification may be modified based on its risk.
4. Risk assessed for the material contained in the final medical device product, it is partial content of registration dossier and processed according to the standard YY0316 and ISO 1497-2012.

2. Safety assessment, Clinical trials and Dossier preparation

(1) Safety assessment (test in the qualified laboratory)

1. The medical device registration inspection should be conducted in Chinese qualified laboratory which approved by CFDA, however, test report of class I medical devices and biological evaluation can be issued by overseas laboratory, but the test method should be equal to Chinese national standard.
2. The electromagnetic compatibility test (EMC) report is mandatory required for class II active medical devices from Jan 1^st 2015.
3. The submission process of in vitro diagnostic (IVD) product is the same to the devices that registration test is prior to clinical trial.
4. You are required to prepare the product technical requirements (TR), other than product standard. The TR is the base contents for registration dossier, testing and certificate.

(2) Clinical trials

1. Clinical assessment report (CAR) is mandatory for all medical device registration under new CFDA regulations. It can be prepared via clinical trial in China, clinical literature or safety and efficiency comparison with the similar device which have been approved on Chinese markets.
2. Clinical trials for higher-risk medical devices should be approved by CFDA when clinical study started, the higher-risk medical devices is designated by CFDA (the first catalogue of medical devices required to be approved on clinical study has been issued)
3. Submit the notification of clinical study protocol to local food and drug bureau.
4. CFDA has issued the catalogue of medical device exempted from clinical trial in China.
5. GCP for medical device-“The Quality Management Practices for Medical Device Clinical Trial” will be implemented soon.
6. The clinical study for IVD should be complied with “the Technical Guidelines for In Vitro Diagnostic Reagents Clinical Trial”.

(3) Instruction manuals, Labels of medical device
The new “Provisions for Instruction Manuals, Labels of Medical Devices” and “Guiding Principle for IVD Instruction Manuals Compilation” have been implemented, medical device registrants should be prepared the instructions and labels according to those new guidance.
a. State the name, address, and contact information of the agents on instruction manuals according to the new version.
b. State the name, location, manufacturing address, serial number of manufacture approval certificate, etc. of the consigned manufacturer on instruction manuals when you consign the consigned manufacturer to manufacture your products.
c. Compile IVD instruction manuals according to the new version.
(4) Quality Management System (QMS)
The GMP for medical device-“The Quality Management Practices for Medical Device Manufacturing” have been implemented, the new GMP extended the QMS requirements and administration to foreign medical device manufacturer.

3. Submission, evaluation and approval

(1) Initial Registration

1. Foreign class I medical devices are only required to record in CFDA and obtain the medical device record-keeping.
2. Overseas Class II and III medical devices are required to apply for and obtain the medical device registration certificate from CFDA before exported to China.
3. There will be taken 93 weekdays for class II medical devices and 113weekdays for class III medical devices for CFDA to approve the application (technical evaluation and administrative approval included)
4. CFDA will check if the foreign device manufacturer has established QMS or maintain and implement it well during the CFDA technical evaluation.

(2) Alteration/Extending Registration (update and renewal of certificate)

1. You shall apply for extending registration (renewal of the registration certificate) more than 6 months in advance.
2. The certificate update and renewal should be applied for separately from April 1^st 2015.

(3) Innovative Medical Devices Registration

If your medical device product is innovative product in China, you can ask your Chinese legal representative to apply for innovative medical device registration via the special review and approval process according to the “Special Review and Approval Procedure for Innovative Medical Devices (Interim)”.

4. Medical device import
Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) is responsible for the inspection supervision and administration of the imported medical devices nationwide.
Commodity inspection exemption: the exemption objects are mainly non-tradable goods such as samples, gifts or goods which are permit to export or import temporarily. Otherwise, commodity inspection is required.

5. Post-market
(1) Medical device advertisement
Medical device advertisements need to be approved by the local food and drug administration of your legal representative prior to announcement. Any device manufacturer whose advertisements break the Chinese laws will be punished and noticed on CFDA official website.
(2) Medical device distribution
The GSP for medical device-“Administrative Measures for the Supervision of distribution of Medical Devices” and “The Quality Management Practices for Medical Device Distributing” have been implemented.

1. Any medical device distributors should comply with the GSP of medical device.
2. Any Class II or III medical device distributors should apply for and obtain the license of medical device distributing from local food and drug bureau.

(3) After-sale service

• The GUP for medical device-“The Quality Management Practices for Medical Device Use” will be implemented soon.
• New regulations have strengthened supervision of medical device adverse events. In addition, CFDA has established adverse events monitoring system and will issue annual report of adverse events monitoring.
• Chinese legal representative shall report to the provincial food and drug bureau when the foreign manufacturers recall products at home and abroad.
  

The CFDA regulatory system is still evolving and ongoing changes and it will impact on medical device regulatory requirements and the obligations for foreign medical device maker, CIRS will trace these regulatory update and changes and give best practices for medical device manufacturers involved in marketing devices in China.