ⅡMedical device management record
Legal overview
According to the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Medical Device Management, enterprises engaged in the management of Class II medical devices shall file with the municipal drug regulatory department where the district is located, and determine the operator's filing certificate.
Those who engage in medical device trading activities without filing a record will confiscate illegal income, illegal medical devices and tools, equipment, raw materials and other articles used for illegal production and business; If the value of the illegally traded medical devices is less than 10,000 yuan, a fine of not less than 50,000 yuan but not more than 100,000 yuan shall be imposed; If the value of the goods is not less than 10,000 yuan, a fine of not less than 10 times but not more than 20 times the value of the goods shall be imposed; If the circumstances are serious, the application for medical device license submitted by the relevant responsible person and enterprise shall not be accepted within 5 years.
Information to be provided
1. Copy of business license
2, legal representative, responsible person, quality responsible person identity, education, title certificate copy
3. Organization chart
4. Geographical location map, floor plan, proof of property rights or lease agreement of premises and warehouse (with proof of property rights)
5, operating equipment list
Remarks: As a municipal administrative business, the requirements vary from place to place, and the details are subject to the regional municipal requirements.
Filing/licensing cycle
Expected period of Class II business filing: 1-1.5 months
The services we provide
- • Compile the filing materials, submit them to the drug administration and be responsible for the whole process until the filing certificate is obtained
- • System construction counseling and system pre-audit, on-site pre-audit special consulting services
Zhongbang is one of the earliest institutions in China to engage in compliance consulting services. It has a senior expert team composed of PhDs, Masters, and Bachelor's degrees, and has established branches in the UK, the United States, South Korea, Beijing, Shanghai, Suzhou, Fuzhou, Shenzhen, and other places, forming a global service network layout.
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Strong technical strength:
A strong team composed of mid to senior technical personnel with professional backgrounds in chemistry, food nutrition and health, medicine, biology, toxicology, environment, and other fields
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International service level:
A business elite team with multiple languages including English, Japanese, German, and Chinese, efficiently serving international customers
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Rich compliance experience:
With years of experience in global product and regulatory research in multiple fields, we are able to provide comprehensive and high-level compliance consulting support to various customers
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Localized service capabilities:
Having multiple branch offices in the UK, USA, South Korea, Beijing, Shanghai, Suzhou, Fuzhou, Shenzhen, etc., we can provide you with services nearby
Service Hotline :400-115-9001
Zhongbang Consulting (Shandong Zhongbang North Management Consulting Co., Ltd.) focuses on product registration and compliance consulting services. With its professional technology, diverse resources, and global network, we are committed to providing regulatory consulting and environmental regulation response services for pharmaceutical, chemical, consumer goods production enterprises, and large multinational corporations. To solve the environmental, health and safety laws and regulations, product quality standards, and other issues faced by enterprises in production, sales, and global trade processes.
Accumulated Customers
15,000+
Distributed in 35 countries and regions
12year
Industry experience
260+
Senior expert team
15+
Subsidiaries
300+
Collaboration Cases
Brand Cases
The choices and trust of over 15000 customers are the driving force for Zhongbang to continuously improve its services. We are willing to grow together with these excellent enterprises
Service Hotline:400-115-9001