醫療器械資質(zhì)辦理流程

1.申請醫療器械生產(chǎn)許可證：申請者需向國家食品藥品監管部門(mén)提交材料，經(jīng)過(guò)審核，如符合相關(guān)要求，會(huì )向申請者發(fā)放生產(chǎn)許可證。

2.申請醫療器械注冊證：在擁有醫療器械生產(chǎn)許可證后，申請者需要向國家食品藥品監管部門(mén)提交醫療器械注冊申請材料，如通過(guò)審核，會(huì )頒發(fā)醫療器械注冊證書(shū)。

3.申請醫療器械市場(chǎng)許可證：擁有醫療器械注冊證后，申請者需要向所在區或市的食品藥品監管部門(mén)申請市場(chǎng)許可證，如通過(guò)審核，會(huì )頒發(fā)市場(chǎng)許可證。

4.繳納相關(guān)費用：在獲得各類(lèi)許可證后，需要向相關(guān)機構繳納相應的證書(shū)費用和資料認證費用。

5.領(lǐng)取證書(shū)：繳納證書(shū)費用后，即可領(lǐng)取醫療器械生產(chǎn)許可證、醫療器械注冊證和市場(chǎng)許可證，正式開(kāi)始運營(yíng)。

How to handle the business license of class III medical devices
1. The business license of Class III medical devices is handled as follows:
(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 site and audit the products;
(4) Grant the issuance of a class III medical device license.

Three kinds of medical devices as the highest risk in the medical device classification category, strictly by the supervision and management, but for many families of three kinds of medical devices, many basic problems is not fully grasp, today we will take a look, what are three business scope of medical devices? How to apply for the three types of medical e business license again!