8、其它相道關材料。

二、辦理三回類醫(yī)療器械許可證的要求：

1、場地要求：必須是辦公性質(zhì)，使用面積要少達到45平方米;

2、人員要求：需要有3名相關人員(公司負責人、質(zhì)量負責人、質(zhì)量檢查人員)的備案并且持有證書;

3、產(chǎn)品要求：必須要有合乎業(yè)務范圍的產(chǎn)品信息，并出具證書;

4、其他相關法律法規(guī)要求。

三、辦理三類醫(yī)療器械許可證的流程：

1、申請人提交申請資料到相關部門;

2、相關部門受理申請人的申請;

3、到實際場地進行勘察以及對產(chǎn)品進行審核;

4、準予頒發(fā)三類醫(yī)療器械許可證。

medical device license: 1, site re: must be office nature, the use area should be less than 45 square meters; 2. Personnel re: 3 relevant personnel (company responsible person, responsible person, inspection personnel) need to record and hold the certificate; 3, product re: must have the product information in accordance with the business scope, and issue a certificate; 4. Other relevant laws and regulation re. 3. Procedures for obtaining the Class III Medical Device License: 1. The applicant shall submit the application materials to the relevant departments; 2. Relevant departments shall accept the application of the applicant; 3. Investigate the actual s