The Chinese medical device market is the fourth largest market in the world. The estimated market value was over 17 billion dollars in 2013 and the market is growing fast. Expected growth is 15-20% per year for the next 10 years, and with Chinese manufacturers not able to meet demand, it makes China an attractive market for foreign medical device companies. On 1 June 2014, the newly revised Regulations for the Supervision and Administration of Medical Devices’ (State Council Order No.650) was put into force. To support the implementation of the regulations, the China Food and Drug Administration (CFDA) formulated and revised five important administrative measures. These administrative measures will go into effect on October 1, 2014.
Chinese Regulatory Environment For Medical Devices
Approval from the China Food and Drug Administration (CFDA) is required for medical devices to be put into the Chinese market.
The most important laws and regulations for medical devices are:
- The Council Statute Order No.650: ‘The Regulations for the Supervision and Administration of Medical Devices’ (enacted on 1 June 2014)
- CFDA Order No. 4: Administrative Measures for Medical Device Registration (will go into effect on 1 October 2014
- CFDA Order No. 5: Administrative Measures for the Registration of In Vitro Diagnostic Reagents(will go into effect on 1 October 2014)
- CFDA Order No. 6: Administrative Rules for the Instructions and Labels of Medical Devices(will go into effect on 1 October 2014)
- CFDA Order No. 7:Administrative Measures for the Supervision of Medical Device Manufacturing(will go into effect on 1 October 2014)
- CFDA Order No. 8: Administrative Measures for the Supervision of distribution of Medical Devices(will go into effect on 1 October 2014)
- Harmonised GB National Standards and YY&YY/T standard (e.g. GB 9706.1:2007 – identical to IEC 60601-1 Ed.2 – and GB 16866 series – identical to ISO 10993 series)
Medical Device Classification And Testing
The CFDA has a similar classification for medical devices as the FDA: Class I devices are carried through routine administration, but Class II and III have stricter controls, accordingly. Provisions for classification are given in CFDA’s Order 15 here.
(NB: To support the new regulations, the updated provisions for classification are in draft format.)
For Class II and III equipment testing, the manufacturer should draft the technical requirements. The requirements are similar to the Essential Requirements Checklist and should:
- Be in compliance with adopted standards (GB National standards and YY &YY/T industrial standards)
- Include performance specification and testing method
For active Class II and Class III devices, the CB test reports do not exempt them from testing, but they can be helpful. The devices will be tested according to the technical requirements in a Chinese testing laboratory that is supervised by the CFDA.
The applicable national standards are:
- For General Safety: GB 9706.1:2007 (identical to IEC 60601-1 Ed.2) is mandatory
- For Class II Devices: EMC testing YY0505:2012 (identical to IEC 60601-1-2:2004) is mandatory from 2015
- For Class III Devices: EMC testing YY0505:2012 (identical to IEC 60601-1-2:2004) is mandatory from 2014
For Class I, the supplied clinical evaluation report will be accepted.
For Class II and Class III device:
- If the device falls under ‘clinical trial exemption database’ the supplied clinical evaluation report will be accepted
- If the device does not fall under ‘clinical trial exemption database’ clinical trial in China is mandatory
(NB: The ‘clinical trial exemption database’ is still in draft format.)
CFDA Application And Registration
The CFDA application and the required documents need to be provided in Chinese and in English. For the application and contacts, a Chinese Registration Agency is required – the manufacturer signs the English versions of documents, and the agency in China signs the Chinese versions.
In addition to the application, several other documents are required:
- Qualification for Manufacture: a certificate issued by the authorities (or Notified Body) of the Country of Origin (CoO) to authorise the manufacturer to manufacture and distribute the medical devices, for example in the EU this is an EN/ISO 13485 certificate
- Approval for the device in the CoO: for example in the EU this is the CE Certificate and Declaration of Conformity
- Qualification of Registration Agency: comprises the License of the Agency and an Authorisation Letter from the manufacturer
- Technical Requirements: typically drafted together with the manufacturer and the registration agency, and based on the user manuals, test reports and technical specifications
- Test Report for Class II and Class III devices: issued by the testing laboratory that is authorised by CFDA, based on the technical requirements
- User Manual and Labelling in Chinese
- Clinical Evaluation Report: (see the clinical requirements)
- Product Quality Guarantee Letter: with this letter the manufacturer guarantees that the quality of the product that is to be registered for sale in China is exactly the same in CoO, and that the quality management system is continuously supervised
- Letter of Authorisation and Letter of Promise for the Responsible Agency in China: the agency will need a business license, will undertake the relevant legal responsibility of product quality, report possible incidents to the CFDA, take care of product recalls, and contact the CFDA and manufacturer when necessary
- Letter of Authorisation and Letter of Promise for the After-sales Agency: the agency will need a business license and will have responsibility of all necessary technical documents, training, spare parts, consumables, and after-sales of the device
- Self-declaration for Documents Submitted: provided by the manufacturer and includes a promise from the manufacturer to undertake legal responsibility
(NB: To support the new regulations the document list above will be updated – no official notice of changes to date.)
In principle, the CFDA technical review and administrative review need 90 working days if there are no on-hold comments.
In practice, the expected lead-time for a Class II device is typically 9-16 months (e.g. documents preparation, testing, CFDA review).
SGS China can assist in scheduling the registration process, give an action plan for each step, provide guidance for the CFDA application and document preparation, and review the documents, communicate with the testing lab and follow-up the review process to ensure smooth progress. Additionally, SGS can give relevant CFDA registration regulation consultation.
For more information please visit SGS Medical Devices Services.
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