Expedited application for Shenzhen Class II medical device business registration certificate

well known, The registration system is slightly more difficult to handle than the licensing system., Shenzhen’s Class II medical device business license is the filing system. The essence of the filing system is that you have to do this, You comply with national regulations, Submit information and follow the process, The relevant departments think there is no problem, With approval and relevant certificates issued, you can operate. What aspects need to be paid attention to in Category II filing?

first, Registration and licensing also require certain conditions to be met., Such as personnel, Business premises, All basic conditions such as the catalog details of the products sold need to be met.. It is not difficult to meet the basic conditions, After all, the filing system is not as strict as the licensing system.. Corresponding professionals and experience are required

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, Educational qualifications

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. Business premises are also needed, Warehouse etc.

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Comply with regulations. Those who do Category II registration should preferably have a college degree or above., Requires at least two.

Quality manager and business manager cum legal person. The address is good and has an area of ​​40-50 square meters.. Too small to pass approval. What equipment does Class II medical devices include? such as thermometer, sphygmomanometer, information aid, oxygen concentrator, condom, acupuncture needle, ECG diagnostic equipment, Non-invasive monitoring equipment, optical endoscope, Portable ultrasound diagnostic instrument, Fully automatic biochemical analyzer, Constant temperature incubator, Dental comprehensive treatment instrument, Medical absorbent cotton, Medical skim gauze, etc..

Detailed list of materials required to apply for a medical device license:

1. Application form in 2 copies, One electronic declaration document.
2. The original and 1 copy of the "Notice of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License" issued by the industrial and commercial administration department.
3. Application report.

(Including introduction to company personnel, Business scale, Business scope, etc.)

1. Business premises, Official documentation of the warehouse location, Include a copy of the property certificate or lease agreement and the lessor’s property certificate.
2. Business premises, Warehouse layout plan.
3. Person in charge of formulating the law, Business person in charge, The identity of the quality manager is correct, Proven academic qualifications and resume.
4. 1 copy of the business quality management specification document catalog, including procurement, acceptance, Warehouse, out of warehouse, Quality tracking, User feedback, Adverse event monitoring and quality incident reporting system and other documents;
5. Enterprise installed product purchases, pin, stored information management system, Print a copy of the homepage of the information management system. What penalties will be imposed on enterprises that do not apply for medical device licenses and violate business qualifications?

Measures for the Supervision and Administration of Medical Devices: The "Measures for the Supervision and Administration of Medical Device Operations" were reviewed and adopted by the State Food and Drug Administration at the executive meeting on June 27, 2014., Now announced, Effective from October 1, 2014.

Remark: According to the "Regulations on the Supervision and Administration of Medical Devices", Enterprises that have not obtained compliance operation qualifications, May be fined not more than RMB 100,000 by the competent authority, Or a fine of not less than 10 times but not more than 20 times the value of the goods may be imposed; Serious circumstances, 5Applications for medical device licenses submitted by relevant responsible persons and enterprises will not be accepted during the year..

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 Hong Kong Xintong, 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% standardized handling, Legal persons cooperate according to the process, No original documents required, Just take a photo, Get the certificate on the same day!

Contact Hong Kong Xintong, 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 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?

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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 52 Daiban! 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 then apply for the Class II medical device business registration certificate)

1. legal representative, Business person in charge, Proof of identity of the quality manager, Copy of academic qualification or professional title certificate
2. Description of organizational structure and department settings. (If not, Please contact us)
3. Business scope, Description of business methods. (If not, Please contact us)
4. 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)
5. Business facilities, Device catalog.
6. Operation quality management system, Work program and other file directories.
7. Certificate of authorization of the person in charge.
8. Other supporting materials. 52 Daiban Business Service One-stop Service, High quality solution to your concerns!

Shenzhen's second-class medical device business registration can be directly approved by 52 Daiban consultants on the same day and get the final preferential price! Related products: Expedited application for Shenzhen Class II medical device business registration certificate