8、其它相道關(guān)材料。

二、辦理三回類(lèi)醫療器械許可證的要求：

1、場(chǎng)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(guān)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(shū);

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(shū);

4、其他相關(guān)法律法規要求。

三、辦理三類(lèi)醫療器械許可證的流程：

1、申請人提交申請資料到相關(guān)部門(mén);

2、相關(guān)部門(mén)受理申請人的申請;

3、到實(shí)際場(chǎng)地進(jìn)行勘察以及對產(chǎn)品進(jìn)行審核;

4、準予頒發(fā)三類(lèi)醫療器械許可證。

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