Shenzhen Medical Device Business License Conditions and Requirements

When applying for a medical device business license, you also need to pay attention to the product authorization documents.。Shenzhen Medical Device Business License Application Conditions

Require

，This document must also be provided by the company itself。These are the things you need to be careful about when applying for a certificate.，How to do it without wasting too much effort on your part、Can you save time and worry and successfully obtain a medical device business license?

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Shenzhen Medical Device Business License Application Conditions

Require

The following conditions should be met：1. Basic production qualifications (

Require

：Need to be consistent with the production product)；2. Production site (

Require

：It needs to be consistent with the production scale and comply with laws and regulations.

Require

）；3. Production facility monitoring equipment (

Require

：It needs to be consistent with the production products and scale and comply with laws and regulations.

Require

）；4. Personnel and organizational structure (

Require

：Personnel qualifications and qualifications should comply with laws and regulations

Require

）；5. product(

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：Need to comply with laws and regulations、professional standards、industry standard、and product technology

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，Three or more samples must pass self-inspection and professional testing，and obtain product registration certificate)；6. Quality management system (system documents and records and effective implementation，Need to ensure that the quality management system meets suitability、sufficiency、effectiveness

Require

）；7. Technical documentation (

Require

：Risk Management Profile、research information、R&D related technical information)；

1. Passed the on-site assessment of the quality management system of the relevant product registration departments；
2. Need to pass on-site audit by the relevant production licensing department；Growth rate leads the world by more than 2 times，China's medical devices account for an increasing share of the world's share。

With the improvement of my country's medical device industry policies and continuous financial support,，The growth rate of my country's medical device market is significantly higher than the global growth rate，Shenzhen Medical Device Business License Application Conditions

Require

2025In 2016, the growth rate of my country's medical device market was more than twice the growth rate of the global market.，Under the guidance of the General Office of the State Council’s “Notice on Deepening the Reform of the Medical and Health System and Key Tasks in the Second Half of 2025” and other policies，It is expected that my country's medical device market size will continue to lead the global growth rate by more than 2 times in 2025.。

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