Medical device network sales filing
Legal overview
According to the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Online Sales of medical devices, enterprises engaged in online sales of medical devices shall be medical device production and management enterprises that have obtained medical device production licenses, business licenses or handled records in accordance with the law. Except where it is not necessary to apply for permission or record according to laws and regulations. Enterprises engaged in the online sales of medical devices shall apply for the record certificate of online sales of medical devices.
Legal liability
If an enterprise engaged in the online sale of medical devices fails to register in accordance with the provisions, the local drug regulatory department at or above the county level shall order correction within a time limit and give a warning; Those who refuse to make corrections shall make a public announcement and be fined not more than 10,000 yuan.
Information to be provided
1. Copy of business license
2, non-operational Internet information service record description (self-built website)
3, Telecom business license (self-built website)
4, "Medical Device Product Registration Certificate/Record Certificate", "Medical Device Production License", "Medical Device Business License" or "Medical device business case preparation Certificate" copy
5, medical device network trading service third-party platform filing certificate (settled class)
The services we provide
- • Provide professional medical device network sales record agent service
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
Consultation
400-115-9001