8、其它相道關(guān)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(dá)到45平方米;

2,、人員要求：需要有3名相關(guān)人員(公司負(fù)責(zé)人、質(zhì)量負(fù)責(zé)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(wù)范圍的產(chǎn)品信息，并出具證書;

4,、其他相關(guān)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(qǐng)人提交申請(qǐng)資料到相關(guān)部門;

2,、相關(guān)部門受理申請(qǐng)人的申請(qǐng);

3、到實(shí)際場地進(jìn)行勘察以及對(duì)產(chǎn)品進(jìn)行審核;

4,、準(zhǔn)予頒發(fā)三類醫(yī)療器械許可證,。

materials. 2. Re for three-of medical device license: 1, the site re: must be the office nature, the use of the 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 regulations and re. 3. Procedures for obtaining the Class III Medical Device License: 1. The applicant shall submit the application materials to the relevant departments