Documents to be provided when importing medical equipment:
State Food and Drug Administration issued by the registration of imported medical devices and medical device registration form
Part of the equipment need to apply for an automatic import license, and some of the need for China's Compulsory Certification (3c) certificate. 3c)
Photographs of the equipment, nameplate, 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 certificates
Declarant's copy of the business license and the manufacturing company to grant the agent registration of the Power of attorney
Overseas government medical device authorities approved or recognized by the product as a medical device to enter the market in that country (region)
Applicable product standards (and instructions)
Medical device instruction manual
Medical device testing organizations issued by the product registration test report,
Medical device clinical trial data
Medical device registration application form
Medical device manufacturer qualification certificate
Applicant business license copy and the agent registration granted by the manufacturer
Product quality guarantee issued by the manufacturer
Production company 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
In China to designate after-sales service agency's power of attorney, the commitment of the commissioned agency and the qualification documents
I hope these can help you.