The consignee should have a medical device license and a general trade clearance certificate
Documents to be provided when importing medical devices:
Imported medical device registration certificate issued by the State Food and Drug Administration and the registration form for medical devices Some of the devices need to apply for an automatic import license, and some need China Compulsory Certification (3c). Part of the need for China Compulsory Certification (3c)Photographs of the equipment, nameplates, technical parameters of the equipment, end use, Chinese manuals and other general trade clearance certificates
Registration for the required information:
Overseas medical device registration application form
Medical device manufacturer qualification certificate
A copy of the business license of the declarant and the power of attorney granted by the manufacturer to act as an agent for registration
Proof of approval or endorsement by the competent authority for medical devices of the overseas government of the product to enter the market of that country (region) as a medical device
Applicable product standards (and instructions)
Medical device instruction manual
Medical device testing agency issued by the Product registration test report,
Medical device clinical trial data
Product quality guarantee issued by the manufacturer
Production enterprises in China to designate the agent's power of attorney, the agent's letter of commitment and business license or certificate of registration of the institution
Designation of the after-sales service agency in China's power of attorney, the commissioned agency's letter of commitment and qualification documents
For details, please contact Xin Poster Customs.