Medical device license application、医疗器械许可证申请条件

Medical device license application、Medical device license

Application conditions

Conditions for applying for medical institution practice license：

1. The non-profit medical institution has obtained approval for its establishment，For-profit medical institutions have obtained commercial entity qualifications；
2. Requires approval from the national or Guangdong Provincial health administrative department，Relevant approval documents should also be obtained；
3. Comply with the standards for setting up medical institutions set by the municipal health administrative department；
4. The name of the medical institution complies with relevant regulations；
5. The person in charge of the medical institution shall not commit any violation of regulations or disciplines；
6. Public medical institutions should also comply with the medical institution establishment plan formulated and issued by the municipal health administrative department.。

、How long is the validity period of the medical institution practice license? For the sake of effective management，Depending on whether there are beds (whether there is scale or not)、strength)，Issuance of medical institution practice licenses with different validity periods，5 years for those without beds，15 years with beds，Upon expiration, you can apply for extension procedures within the specified period.。

Specific matters regarding administrative licensing conditions

1. Legal representative of the enterprise、Business person in charge、Quality management personnel should not have the circumstances specified in Article 40 of the "Regulations on the Supervision and Administration of Medical Devices";
2. The enterprise should have a quality management organization or full-time quality management personnel that is commensurate with its business scale and scope.;Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state，Professional and technical personnel who have been qualified in accordance with the law。

For example, the quality manager should be on-the-job，Not allowed to work part-time in other units

1. Have a relatively independent business location that is commensurate with the business scale and scope of business。
2. Have storage conditions suitable for the business scale and business scope(storage device、facility)。
3. Have technical training on operating products、After-sales service capabilities。
4. Should be based on relevant national and local regulations，Establish and improve the necessary quality management system，and strictly enforce。
5. National standards for medical devices should be collected and preserved、Industry standards and regulations on medical device supervision and management、Regulations and special provisions。
6. Passed the acceptance inspection in accordance with the "Implementation Standards for the Acceptance of Medical Device Business Enterprises in Guangdong Province"。

About Hong Kong Xintong

Hong Kong Xintong focuses onGuangdong and Hong Kong license plates、Shenzhen Hazardous Chemicals Business License、Shenzhen labor dispatch licenseandShenzhen Charity Foundationapplication services，Assist customers to applyShenzhen travel agency business license、Shenzhen pawn shop business license、Shenzhen auction house license and other mainstream domestic financial licenses，Support enterprises to achieve compliance expansion of cross-border financial business。Also availableODI overseas investment registration、International travel agency registration and other services，Help enterprises expand their presence in international markets。Provide one-stop compliance solutions for enterprises。To learn more，Please contactHong Kong Information Communications Consultant。