Methods and procedures for business registration of Class II medical devices in Shenzhen

Apply for Class II medical device registration，What about the business premises and personnel?

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"Details" provides a detailed introduction to the application for registration of Class II medical devices.，What about the business premises and personnel?

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How to register for a medical device business license，There are 44 categories of medical devices，Each category is divided into one、Category II、Category three，Depend on the products you need to make here。For a class it is relatively simple，No license required。

Category II、Category three requires filing and application for a medical device business license。I am applying for the "Class II Medical Device Business Registration Certificate" and want to successfully pass the review by the Drug Inspection Bureau.，The key parts are three parts：Registered address、personnel

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、Related materials。

one、For Class II medical device business registration registration address:

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：

1. The office area is not less than 50 square meters；
2. The warehouse area is not less than 50 square meters；(Those containing in vitro diagnostic reagents require a refrigerated warehouse)
3. If disposable consumables are included

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The office address and warehouse area together cannot be less than 150 square meters Note：Business premises and warehouses are not allowed to be located in residential buildings.、For Class II medical device business registration personnel, there are

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：1、A legal person who concurrently serves as the person in charge of the enterprise needs to have a college degree or above**，Not professional

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；2、The quality manager needs to have more than 3 years of work experience，College degree or above**，Graduated from related majors；Medical device related majors：medical device、biomedical engineering、mechanical、electronic、medicine、Bioengineering、Chemical、Nursing、recovery、Laboratory Science、manage、Computer and other majors 3、For the second type of medical device business registration materials, there are

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：

1. Class II medical device business registration application form
2. Copies of business license and organization code certificate；
3. legal representative、Business person in charge、Proof of identity of the quality manager、**Or a copy of professional title certificate；Quick processing of business and sales registration of Class II medical devices in Shenzhen，Cheap price, simple information, service content:Professionally handle Class II medical device business licenses，sales license，Internet sales license，Contact Lixin International Port Information Communication-，Simple information，Issue the certificate on the same day. Apply for the "Class II medical device business registration certificate". Continue to receive orders.，Category 2 is also available in batches 6864:Masks Category II 6834:Protective clothing Category II 6820:Thermometer 100% guaranteed，Legal persons do not need to be present，No original documents required，Just take a photo，Get the certificate on the same day!

Contact Lixin International Port Information Communication-，Just provide a photo of your license to apply，Simple information，The procedure is fast!

The emergency response level for COVID-19 prevention and control in Guangdong Province has been adjusted from the first-level response to major public health emergencies to the second-level response，previously，In response to the epidemic, Shenzhen issued a notice on the emergency filing guidelines for Class II medical devices during the epidemic prevention period. The emergency response was changed from Level 1 to Level 2.，The notice has been cancelled. The Shenzhen Municipal Market Supervision and Administration Bureau now provides relevant explanations on the content of the notice. The suspension of processing categories is based on the relevant regulations of the Guangdong Provincial Food and Drug Administration.

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，2025From March 1，Shenzhen Municipal Market Supervision Bureau will stop the emergency filing of Class II medical devices required for epidemic prevention and control。

Please note that all relevant operating companies，It is the Shenzhen Municipal Market Supervision Bureau’s suspension of emergency registration for the second category of medical device products and production required for epidemic prevention.，Rather than suspending all Class II medical device business registration。 epidemic prevention period，Companies can still apply to the Guangdong Provincial Food and Drug Administration for emergency approval of Class II medical devices。

Enterprises that have received emergency approval for epidemic prevention can go to the Provincial Food and Drug Administration to register for normal operations. There is no need to rush for time. The guidelines for the registration of second-class medical devices are based on the "Regulations on the Supervision and Administration of Medical Devices"，Those engaged in the business of Class II medical devices，The operating enterprise shall file a record with the food and drug supervision and administration department of the people's government of the districted city where it is located and submit the certification materials that it meets the conditions specified in Article 29 of these Regulations.。

Lixin international business service one-stop service、High quality solution to your concerns! Shenzhen Class II medical device business registration can be directly approved by Manager Lin on the same day and get the final preferential price! Related products：Methods and procedures for business registration of Class II medical devices in Shenzhen

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