What are the requirements for applying for a Shenzhen medical device business license? How much does it cost to hire someone to do it for you?

How to apply for a medical device business license?医疗器械经营许可证的办理可以咨询深圳公司进行办理，We are a one-stop service that specializes in business services for enterprises，Consultation is available for processing。

Our company's main business：Franchise license(Human Resources License、Labor dispatch license、Medical device license、Property qualification license、Dangerous goods business license、Health product business license、health license、road transport license、Security service company license、Refined oil business license、ICP business license、Express business company registration、Shenzhen training institution established)，Customers in need please call for consultation。

Minato Shindou-： 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。

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"。

=yesterday，The executive meeting of the Guangzhou Municipal Government reviewed and approved the "Guangzhou Municipal Medical Device Operation and Use Supervision and Management Measures"(draft)》(Hereinafter referred to as the "Measures")，lecture、Those who promote medical device products through on-site experiences or other forms should report to the food and drug administration department in the area where the event is held 7 days in advance.，Any unit or individual using medical equipment to carry out free diagnosis and treatment activities should also present relevant professional qualification certificates at the site，Medical device quality and safety issues will be interviewed by the Food and Drug Administration。

lecture、Promoting medical device products through on-site experience and other forms has become a common marketing method in recent years.，Because regulatory authorities are unable to grasp the timing of their promotional activities、Place，It is easy to form a regulatory gap。Some criminals use this to promote fake and shoddy medical device products to deceive consumers.，Especially middle-aged and elderly people。

lecture、Promote medical devices to consumers through on-site experience and other forms or have the same intended purpose as medical devices、of similar products，Event organizers should report the event time to the food and drug administration department in the area where the event is held 7 days in advance.、Location, etc.。After receiving the report, the food and drug administration departments of each district，Inspections will be stepped up。

He expressed，About on-site promotion、Medical promotion activities such as experience，Anyone in the city can report to 12345，Reports can also be made through various channels such as the Internet and the reporting hotline announced by the drug regulatory system.。

also，In view of the fact that some criminals in society are using medical institutions fraudulently、in the name of a physician，Free medical treatment，Covertly selling drugs illegally、The phenomenon of medical device products，"Measures" proposed，Any unit or individual using medical equipment to carry out free diagnosis and treatment activities，Relevant professional qualification certificates of medical institutions and medical personnel should be presented on site;If not shown，His diagnosis and treatment qualifications are not credible.。

The "Measures" also add a new interview system，Such as medical device operators、The user unit has been reported many times due to medical device quality and safety issues.、Complaints or media exposure, etc.,The Food and Drug Administration can interview its legal representative、Main person responsible。Record of interview recorded in credit file,and notify relevant authorities at the same time、Industry associations，The food and drug supervision department will also list the interviewees as key supervision objects。

=How to apply for a medical device business license?医疗器械经营许可证的办理可以咨询深圳公司进行办理，We are a one-stop service that specializes in business services for enterprises，Consultation is available for processing。

Our company's main business：Franchise license(Human Resources License、Labor dispatch license、Medical device license、Property qualification license、Dangerous goods business license、Health product business license、health license、road transport license、Security service company license、Refined oil business license、ICP business license、Express business company registration、Shenzhen training institution established)，Customers in need please call for consultation。

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The background of the story is set in modern society，It's a folklore about a Selki elf，She is the last creature that has the appearance of a seal but can take on human form.，Trying to return to the sea - that is the time when the fairy tale world is about to end，All creatures that only exist in folklore are under the influence of modern society，Falling more and more、corruption，They don't want to go back at all，But the elf's singing is the only way to bring them back...

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