1, medical equipment business license
2, medical device registration certificate (including medical device registration form)
3, automatic import license of electromechanical products / electromechanical certificate / O certificate
4, 3C certification
5, photos of the device, the nameplate, the technical parameters of the device, end use, Chinese manuals, etc.;
6, packing list invoice contract bill of lading, organization code certificate, business license
7, and other required customs information
Note: whether to electromechanical certificates and 3C, you need to treat specific goods
If you need to electromechanical certificates or 3C, you need to prepare in advance electromechanical certificates or 3C to avoid delay in customs clearance. The inspection time delay
Two, the registration of imported medical devices need to declare what information?
1, overseas medical device registration application form
2, medical device manufacturer qualification certificate
3, a copy of the declarant's business license and the manufacturer granted by the proxy registration of power of attorney
4, the overseas government medical device authorities approved or recognized by the product as a medical device to enter the market in the country (region) of the documents
5, the applicable medical device certificate or 3C, to avoid delay in customs clearance, to avoid the delay in the inspection of medical devices
2, what information need to be declared? p>
5, the applicable product standards
6, medical device instructions
7, medical device testing organizations issued by the product registration test report such as the product is a class does not need)
8, medical device clinical trial information (Class III implantable products into China for the first time and the manufacturer has no other products have been sfda registration; as well as the foreign marketing approval ii, iii (Approval of class ii, iii products need to conduct clinical trials in China)
9, product quality assurance issued by the manufacturer
10, the manufacturer's designated agent in China's power of attorney, the agent's letter of commitment and business license or certificate of registration of the organization