2, medical device manufacturer qualification Z Ming
3, the declarant's business ZZ and the manufacturer granted the proxy registration of the 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) Z Ming documents
5, Applicable product standards (and instructions)
6, medical device instructions
7, medical device testing organizations out of the product registration test report
9, product quality warranty issued by the manufacturer
10, the manufacturer's designated agent in China's power of attorney, the agent's statement of commitment and business ZZ or agency registration Z Ming
11, in China to designate the after-sales service organization's power of attorney, the commissioned organization's letter of commitment and qualification Z Ming document Note: This certificate is valid for four years, six months before the expiration of the validity period should apply for reregistration