HOW TO OBTAIN MEDICAL DEVICE APPROVAL IN CHINA
Regulations
Medical devices are covered by the Regulations for the Supervision and Administration of Medical Devices which have been fully in force since April 1, 2000. The State Food and Drug Administration (SFDA) is directly under the State Council, and has the responsibility for the supervision of the safety management of food, health food and cosmetics and is the competent authority for drugs and medical devices.
The main roles of the Department of Medical Devices under SFDA are for medical devices to: draft standards; set professional standards and good manufacturing practices of medical devices and supervise their implementation; formulate the list of classified medical devices in consultation with health authority under State Council; register and regulate medical devices; monitor adverse events; certify clinical investigations and certain national institutions.
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Scope and Classification of Devices
The regulations cover general medical devices, active implantable medical devices and in vitro diagnostic (IVD) medical devices. All medical devices are classified into Class I, II or III with one set of rules for medical devices and one set of rules for IVDs. The rules for medical devices are similar but not identical to the rules in Annex IX of EC Directive 93/42/EEC.
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Technical Documentation
All manufacturers must have technical documentation in Chinese showing the devices meet the Safety and Effectiveness Requirements in the regulations. Usually all medical devices must meet appropriate Chinese state or industrial product standards, many of which are technically identical to equivalent international product standards. If no such product standards exist the manufacturer must establish a company standard for each device which must be registered with the competent authority. The technical documentation for Class II and III devices shall include a recent (within one year) Type Test Report produced by a medical devices quality test agency recognized by the SFDA. A clinical trial report is required for some medical devices as specified in appendix 12 of the Provision of Medical Device Registration.
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Quality Systems
Domestic manufacturers of Class II/III devices require an assessment of their quality management system from the Provincial FDA in accordance to the Provision of Medical Device Quality System Assessment when they apply for a Medical Device Manufacturing Enterprise License. The quality management system must incorporate all the requirements of the Regulations. Own Brand Manufacturers are included in these requirements. Provincial FDA will exempt manufacturers from such assessments if the applicant holds a valid YY/T0287-2003(identical ISO 13485:2003) certificate which was issued by an SFDA Recognized Certification Body.
Foreign manufacturers will require an accredited ISO 13485:2003 certificate but will not be subject to a separate audit under Chinese regulations.
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Local Distributors, Licenses and Registration
All domestic Class II /III manufacturing site must hold a Medical Device Manufacturing Enterprise License. All domestic distributors of Class II /III devices must hold a Medical Device Distributing Enterprise License. All medical devices sold in China shall have a Registration certificate. Such Registration certification for all imported medical devices shall be approved by the SFDA via the foreign manufacturer’s Legal Representative in China. It is a mandatory requirement to have a registered distributor or importer in China with a Medical Device Distributing Enterprise License approved by Provincial FDA.
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Future Developments
There are some significant changes planned for the immediate future as SFDA had issued a draft regulation for comment. This includes device registration, recall procedures, etc.
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SGS Certification
International certification bodies such as SGS cannot currently be in the SFDA Recognized Certification Bodies. However, all medical device certification issued by SGS i.e. UKAS accredited ISO 13485, CE Mark certification, CMDCAS certification, JPAL and FDA registrations and approvals will support the application by a foreign manufacturer to the SFDA for Registration certification of their devices.
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SGS Training
SGS offers in house and public training on the Regulations for the Supervision and Administration of Medical Devices and the changes needed to the quality system to ensure compliance.
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Contact SGS
Advice on Regulations for the Supervision and Administration of Medical Devices and any enquiry for medical device certification is available from SGS.
This summary should not be taken as a definitive description of the requirements as regulations and interpretations do change and this is intended to be an outline only. Manufacturers must verify the requirements that apply to them before proceeding.
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