Documents for Customs Clearance in China for Imported Medical Devices
Customs clearance documents required for imported medical devices include sales contract, invoice, packing list, business license, Chinese label, user¡¯s manual in Chinese, registration certificate for medical device, medical device registration record, product pictures, name plate, specifications and end use . Medical devices that fall into catalogue of products subjects to China Compulsory Certificate shall provide with CCC certificate. Some medical equipment shall obtain automatic import license before importation. Pictures£¬name plate, technical specifications, end use and Chinese product description are also required.
The consignee of imported medical devices shall possess below qualifications,
1.Business license for medical devices
2.Its business scope shall cover sales permit of the medical devices
3.Import right. If consignee does not have import right, we can be the import agent and provide the import title.
Required documents for obtaining registration certificate for medical devices
1.Application form
2.Evidentiary materials
2.1 Certificates issued by competent department of medical device at the country or region of overseas applicant¡¯s registration place or production address that allow the subject product to be sold on the market as medical devices, and that prove the applicant possess relevant qualification(s).
2.2 In case that the country or region of overseas applicant¡¯s registration place or production address has not yet regulates the subject product as medical devices, the applicant shall provide relevant documents to prove that, including certificate that the country or region of registration place or production address allows the subject product to be sold on the market.
2.3 letter of authorization that the overseas applicant appoints its agent in Chinese mainland, the agent¡¯s letter of commitment and business license photocopy
3. detailed list for basic requirements of safety and effectivity of medical devices.
4. summary documents
5. research documents
6. production info
7. clinical assessment document
8. production risk analysis document
9. product technical requirements
10. test report for product registration
11. product description and Chinese label draft for the smallest selling unit.
12. Statements of Conformity
12.1 Applicant states that the subject product meets the requirements of Registration Management Method and relevant regulations.
12.2 Statement of Self-Assurance made by applicant and its agent.
Registration certificate for medical devices is valid for 5 years and shall be renew 6 months before it expires.
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