Requirements for applying for a medical device business license

Apply for a medical device business license

Require

Operating medical devices must comply with regulations

Require

Apply for business license，The medical device business license is a must-have certificate for the three types of medical device operating companies.，Establishing a third-category medical device operating enterprise，should report to the province、autonomous region、Application from the drug regulatory department of the people's government of the municipality directly under the Central Government;Establishing a third-category medical device operating enterprise，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"。

Medical device business license is now post-approval，The industrial and commercial administration department shall apply for approval after issuing a business license.。The "Medical Device Business Enterprise License" is valid for 5 years。

Essential for applying for a medical device business license

Require

Business premises、storehouse

1. The office space must be a commercial building；(Commercial and residential use is also possible)
2. The registered address of the company and the warehouse address should be the same address and connected as a whole from top to bottom and left to right.，Its construction area shall not be less than 180㎡
3. Cold storage is required：automatic monitoring、show、record temperature、Automatic alarm equipment (diagnostic reagent category 6840，Not less than 20m³)； personnel

Require

1. Equipped with personnel appropriate to the size of the company；
2. quality manager，Bachelor degree or intermediate professional title or above，More than three years of experience in quality management of medical equipment operations
3. Operating in 6846 (excluding hearing aids) or 6877，At least one person with a bachelor's degree or above in a medical-related major or an intermediate professional title or above；Those operating 6822 (including contact lenses and care solutions) or 6846 (including hearing aids)，At least one professional who has been trained in fitting technology by a nationally recognized third-party organization or authorized manufacturing enterprise。
4. Among the quality management personnel engaged in in vitro diagnostic reagents (6840 includes in vitro diagnostic reagents)，There should be one person in charge of the inspector，Or have a college degree or above in inspection-related majors and have more than 3 years of work experience in inspection-related work。Personnel engaged in acceptance and after-sales service of in vitro diagnostic reagents，Must have a technical secondary school degree or above in a laboratory-related major or have a professional technical title of junior inspector or above。

Supporting documents Employee labor contract Education certificate Work certificate Health certificate House ownership certificate Qualification documents and authorization for operating products After-sales service agreement Facilities，equipment

Require

1. storehouse、Cold storage area division (delivery area、Qualified product area、Inspection area、Defective product area、returns area)；
2. Warehouse layout needs preparation：curtain、screen window、air conditioner、backing plate、shelves、Fly killer lamp、mouse guard；Thermohygrometer；
3. At least there is a phone、printer、fax machine、Desktop computers (no less than 3)、Filing cabinets, etc.。
4. computer information management system

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