Port communicationIf it only involves the business of Class II medical devices，Only need to apply for the "Second Class Medical Device Business Registration Certificate"，No license required。
"Class II Medical Device Business Registration Voucher"，State the following information：1、Registration number：like，Husong Food and Drug Administration Operation No. 20250090 2、legal representative：That is, corporate legal person 3、Business person in charge：Can there be a legal person in charge 4、Business style：Divided into three categories，They are wholesale、retail、Wholesale and retail business 5、address：That is, the address registered on the business license is 6、Business premises：i.e. consistent with residence7、Warehouse address：Such as operating a business containing in vitro reagents，And entrust a third party to deliver，The warehouse address can be written as [All products are entrusted to "xxxx Medical Equipment Co., Ltd." for storage、Delivery】8、Business scope：Such as Class II medical devices (excluding in vitro diagnostic reagents) 9、Filing department：District Market Supervision and Administration Bureau10、Filing Date Shenzhen Class II Medical Device Operation and Sales Filing Quick Processing，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.
Require
，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 with emergency approval for epidemic prevention can go to the Provincial Food and Drug Administration for normal business registration. Enterprises do not have to rush for time. The guidelines for the second-class medical device business registration 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.。
Class II medical device business registration time description 1、The business registration of Class II medical devices is a statutory filing matter of the Shenzhen Municipal Market Supervision Bureau.，Processing will not stop after March 1, 2025。 two、All relevant operating enterprises shall comply with the operating conditions for Class II medical devices stipulated in the "Regulations on the Supervision and Administration of Medical Devices" and the "Measures for the Supervision and Administration of Medical Device Operations"，Actively prepare，Orderly filing，No need to rush to apply before March 1。
Atten：How to register Class II medical devices?What about the business premises and personnel?
Require
Registration for your Class II medical device business,Let you plan your business,Successfully passed the e-commerce platform certification...,Adult supplies and other necessary Class II medical devices can be processed，Just look for Lixin International! Detailed explanation of the process for applying for a Class II medical device registration certificate；What are the procedures for applying for a Class II medical device business license?
Now selling Class II medical devices on Taobao,What information is needed to apply for a Class II medical device business registration certificate in Shenzhen in 2025?
Presumably these are the issues you are concerned about when engaging in the business of Class II medical devices.，Business enterprises shall register with the local food and drug supervision and administration department at the districted municipal level.，Fill out the Class II Medical Device Business Registration Form，and submit the following information：1.Copies of business license and organization code certificate. (If the company has not been registered yet, please go to the company first.
Registration process
，After obtaining the company license, you can apply for the Class II medical device business registration certificate) 2. Legal representative、Business person in charge、Proof of identity of the quality manager、Copy of academic qualifications or professional title certificate 3. Description of organizational structure and department setup. (If not，Please contact us) 4. Business scope、Description of business methods. (If not，Please contact us) 5. Business premises、Geographical location map of warehouse address、floor plan、A copy of the property ownership certificate or lease agreement (with the property ownership certificate attached). (If not，Please contact us) 6. Operating facilities、Equipment catalog.7. Operation quality management system、Catalog of documents such as work procedures. 8. Authorization certificate of the person in charge. 9. Other supporting materials. 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：Shenzhen Class II Medical Device Wholesale and Retail Sales Registration Guidelines
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