The first imported medical device product registration to submit what materials?

The first imported medical device product registration materials to be submitted; 1, overseas medical device registration application form; 2, medical device manufacturer's qualification certificate; 3, a copy of the declarant's business license and the manufacturer's grant of the proxy for the registration of the power of attorney; 4, the overseas government medical device authorities to approve or approve the product as a medical device to enter the country's (regional) market documents; 5, the applicable product standards (two); 6, medical device instructions; 7, product registration test reports issued by medical device testing organizations (for the second and third class of medical devices); 8, applicable Product standards (two copies); 6, medical device instructions; 7, medical device testing organizations issued by the product registration test report (applicable to the second and third class of medical devices); 8, clinical trials of medical devices; 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; 11, Designated after-sales service organization in China's power of attorney, the commissioned organization's letter of commitment and qualification documents; 12, the authenticity of the materials submitted to the self-assurance statement. You can go to Ao Zi Da medical equipment consulting organization to understand.