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China Market Access
Registration
撰稿：lzk更新日期：2020-10-21
The product registration is implemented for the manufacturing of medical devices. All medical devices entering China market are required to obtain pre-market approval from the SFDA. The approval is known as the medical device registration. Detail registration requirements for different categories of medical devices are listed below.
Table 1 Registration requirements for medical devices
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CATEGORY
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requirements
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Class Ⅰ devices
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Shall be inspected, approved and granted with a registration certificate by the drug regulatory authority of the government of the municipalities consisting of districts.
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Class Ⅱ devices
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Shall be inspected, approved and granted with registration certificates by the drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government.
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Class Ⅲ devices
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Shall be inspected, approved and granted with registration certificates by the drug regulatory authority directly under the State Council
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When applying for registration of medical devices, technical standards, testing report and other relevant information shall be submitted according to provisions. For Class II and Class III products, it is required to type examination in some assigned test centers in China. Test centers could be selected based on the accredited product list. For a series of products with same or similar intended use, technical structure and specifications, the applicant may exclusively test the typical one which represents the safety and effectiveness of the other products. Class I products are exempt from testing.
The drug regulatory authority of the government of the municipality consisting of districts shall decide within 30 working days if the product can be registered, counting from the date of acceptance of the application. For those not approved for registration, a written explanation shall be given to the applicant. The drug regulatory authority of governments of provinces, autonomous regions and municipalities directly under central government shall decide within 60 working days if the product can be registered, counting from the date of acceptance of the application. For those not approved for registration, a written explanation shall be given to the applicant. The drug regulatory authority under the State Council shall decide within 90 working days if the product can be registered, counting from the date of acceptance of the application. For those not approved for registration, a written explanation shall be given to the applicant.
In case any situation reflected in the content of the registration certificate is changed, the holder of the certificate shall apply for an amendment of the certificate accordingly, or for re-registration within 30 working days from the change. The term of validity for the registration certificate of medical devices is four years. The holder of the certificate shall apply for re-registration within six months before the certificate expires. When the manufacturing of a medical device is stopped continuously for more than 2 years, its registration certificate is automatically invalidated.
l Documents required for initial registration of import products:
1) Application form for the registration of an import medical device
2) Legal qualification certification for the medical device manufacturer
3) A copy of the applicant’s business license and the proxy for registration entrusted by the manufacturer
4) Documents proving that the product can enter a certain country (or region) as medical device approved or accepted by the respective competent departments of overseas governments; if such certification could not be provided, the manufacturer should submit risk analysis reports, clinical trial reports, etc. – the production quality system will be audited by the SFDA
5) Applicable product standard
6) Operational manual
7) Test reports on product registration issued by medical device inspection institutions (applicable to Class II and Class III medical devices)
8) Clinical trial reports
9) Product quality guarantee issued by the manufacturer certifying that the quality of the product to be registered for sale in China is exactly the same as that of the product marketed in the country (region) of origin
10) Proxy of the assigned agent of the manufacturer in China, written commitment of the agent, and agent’s business license or registration certificate
11) Letter of authorization for the designated after-sales service agency in China as well as letter of promise and business license of the authorized agency
12) Self-declaration by the manufacturer to guarantee the truthfulness of the documentation submitted
l Documents required for re-registration of import products:
1) Application form for the registration of an import medical device
2) Legal qualification certification for the medical device manufacturer
3) A copy of the original registration certificate
4) Documents proving that the product can enter a certain country (or region) as medical device approved or accepted by the respective competent departments of overseas governments
5) Applicable product standard
6) Operational manual
7) Test reports on product registration issued by medical device inspection institutions (applicable to Class II and Class III medical devices)
8) Tracking reports on product quality
9) Product quality guarantee issued by the manufacturer certifying that the quality of the product to be registered for sale in China is exactly the same as that of the product marketed in the country (region) of origin
10) Proxy of the assigned agent of the manufacturer in China, written commitment of the agent, and
11) agent’s business license or registration certificate
12) Letter of authorization for the designated after-sales service agency in China as well as letter of
13) promise and business license of the authorized agency
14) Self-declaration by the manufacturer to guarantee the truthfulness of the documentation submitted
For more information please contact 86-755-83997910 or email to wrr@sist.gov.cn
