Shenzhen medical device business license application process，Transfer of multiple Shenzhen medical device licenses

A medical device business license is a must-have document for medical device operating companies.，Start a first-class medical device operating enterprise，should report to the province、autonomous region、Registration with the Drug Supervision and Administration Department of the People's Government of the Municipality directly under the Central Government; Open a second category、Category III medical device operating enterprises，Should reflect on、autonomous region、Review and approval by the drug regulatory department of the municipal people’s government，And issued a "Medical Device Business Enterprise License"。

Without a "Medical Device Business Enterprise License"，The industrial and commercial administration department shall not issue business licenses。The "Medical Device Business Enterprise License" is valid for 5 years。

How to apply for a Shenzhen medical device business license?

Process

、condition?Please contact Hong Kong Xintong International Hong Kong Xintong- Shenzhen Medical Device Business License

Process

： (one)Application and acceptance

1. Enterprises produce products listed in the catalog，Submit an application to the provincial quality and technical supervision bureau where it is located，and submit the following application materials：1)"National Industrial Product Production License Application Form" in triplicate;2)Three copies of business license;3)Three copies of production license certificate(Enterprises that re-apply for a production license after its validity expires);4)Product implementation details

Require

of other materials。

1. After the provincial Quality and Technical Supervision Bureau receives the application from the enterprise,，Comply with the implementation details of application materials

Require

of，accepted，And send the "Administrative Licensing Application Acceptance Decision" to the enterprise within 5 days from the date of receipt of the enterprise's application.;Application materials that do not comply with these implementation rules

Require

and can be achieved through correction

Require

of，A one-time notification of "Notice of Supplement and Correction of Administrative Licensing Application Materials" should be sent to the enterprise on the spot or within 5 days.。

Failure to notify after the due date，The application will be accepted from the date of receipt of the application materials.;Application materials that do not comply with the Administrative Licensing Law and the Regulations on the Administration of Industrial Product Production Licenses

Require

of，A decision should be made to reject the application，and issued a "Decision on Not Accepting Administrative Licensing Application"。3.The implementation rules stipulate that the review department is responsible for organizing the review，The provincial licensing office shall submit all application materials to the review department within 5 days from the date of accepting the enterprise's application.。

(two)Enterprise on-site inspection

1. According to product implementation details

Require

，Review organized by the provincial quality and technical supervision bureau or review department。

1. The provincial licensing office or inspection department develops an enterprise on-site inspection plan，Notify the company 5 days in advance，Reviewed by the review department，The review department will also send a copy of the verification plan to the local provincial licensing office.。
2. The provincial licensing office or inspection department assigns 2 to 4 inspectors to form an inspection team，Conduct on-site inspections of enterprises，Enterprises should cooperate。
3. The review team follows the product implementation details

Require

，Conduct on-site inspections of enterprises，The verification time is generally 1-3 days。The review team is responsible for the results of the company’s on-site verification，and implement the team leader responsibility system。

1. The provincial quality and technical supervision bureau is responsible for organizing the review，The provincial licensing office shall have 30 days from the date of accepting the enterprise’s application.，Complete on-site inspection of enterprises and take samples，and notify the inspected enterprise in writing of the conclusions of the on-site inspection.;Reviewed by the review department，The review department shall within 30 days from the date of accepting the enterprise’s application，Complete on-site inspection of enterprises and take samples，and notify the inspected enterprise in writing of the conclusions of the on-site inspection.，Also notify the provincial licensing office。
2. If an enterprise fails to pass the on-site inspection, it will be deemed that the enterprise has failed the inspection.，The provincial licensing office or review department shall submit the report in writing to the State Administration of Quality Supervision, Inspection and Quarantine.，And the General Administration of Quality Supervision, Inspection and Quarantine will issue a "Decision of Not Granting Administrative Licensing" to the enterprise.。 It is reported that，Enterprises whose "Medical Device Business Enterprise License" has been canceled，is not allowed to continue operating 2、Class III medical devices。

two、Class III medical devices are medical devices with higher risks，in，The second category refers to product mechanisms that have obtained international and domestic recognition.，Technology is mature，security、effectiveness must be controlled，Such as X-ray film machine、B-ultrasound、microscope;The third category refers to implantation into the human body，or for life support，or complex technical structure，May be potentially dangerous to humans，security、The effectiveness must be strictly controlled，such as a pacemaker、anesthetic、Ventilator etc.。

Most of the companies that were deregistered this time were independent pharmacies.，In accordance with the relevant provisions of the national "Regulations on the Supervision and Administration of Medical Devices" and "Measures on the Supervision and Administration of Medical Device Operations"，New applicants engaged in the second category、Applicants for operating Class III medical devices must be enterprises registered with the industrial and commercial department in accordance with the law.。

When the medical device business license of the original individual industrial and commercial household is applied for change or expiration extension，You can apply to transform into an enterprise organization form，Register with the Food and Drug Administration or apply for a business license。If it has not been transformed into an enterprise organization form，Will no longer be able to sell medical devices。 Conditions for applying for Shenzhen medical device business license、process、

cost

、cycle，and medical device business license transfer。

About Hong Kong Xintong

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