Shenzhen Class II Medical Device Registration，Shenzhen Class II Medical Device Registration Online Application Process

As the global epidemic situation slowly stabilizes,，Business in many industries has begun to slowly pick up。Most of the industries that can feel the rebound in business involve the foreign trade industry。

Enterprises involved in foreign trade business will definitely have the need for qualification certification.，Projects that have been temporarily shelved due to industry instability due to the impact of the previous epidemic，Now that the epidemic situation has stabilized, companies can start planning their industry layout.，Issues related to medical device qualification certification，You can contact Hong Kong Xintong International to handle it for you.。first，What is a medical device?

Medical devices refer to instruments that are used directly or indirectly on the human body、equipment、utensil、In vitro diagnostic reagents and calibrators、Materials and other similar or related items，Includes required computer software。The medical device business license is a must-have document for the three types of medical device operating companies.。The state implements classified management of medical devices according to risk levels。One category is low risk，Implementing routine management can ensure its safety、effective medical device。

Like a scalpel、surgical scissors、gauze bandage、medical ice pack、stethoscope etc.。Category 2 is a medium risk，Strict control and management are required to ensure its safety、effective medical device。For example, the common thermometer in our daily life、sphygmomanometer、electrocardiograph、Atomizer, etc.。The third category is with higher risk，Special measures need to be taken to strictly control and manage it to ensure its safety、effective medical device。

Such as common contact lenses、syringe、intravenous indwelling needle、heart stent、Ventilator、CT、NMR, etc.。Among them, the establishment of a second-category medical device operating enterprise，should report to the province、autonomous region、Registration with the Drug Supervision and Administration Department of the People's Government of the Municipality directly under the Central Government。Establishing a third-category medical device operating enterprise，Should reflect on、autonomous region、Review and approval by the drug regulatory department of the municipal people’s government，And issued a "Medical Device Business Enterprise License"。

Medical device business license is now post-approval，Valid for 5 years。The validity period has expired and needs to be extended，Handle extension procedures in accordance with legal provisions on administrative licensing。

Required materials for processing：

1. Company name and business scope，Registered capital and shareholder capital contribution ratio，Proof of identity of shareholders, etc.；
2. Medical device product registration certificate、Supplier business license、Licenses and Authorizations；
3. Quality management documents, etc.；
4. 2Certificates for one or more medical majors or related professionals、Proof of identity and resume；
5. Comply with medical device business

Require

Proof of office space and warehouse；

1. Articles of Association、Shareholders' meeting resolutions, etc.；
2. Other related materials。

as an entrepreneur，Not only should we pay attention to business development and market changes，And we should always pay attention to specific local policy trends.。Only by adjusting business and market directions based on benchmarking policies can we obtain optimal resources in a limited market environment.，As for the qualification processing issues that match the business, you need to consult the professional qualification processing company Hong Kong Xintong team to handle it for you! Related products：Shenzhen Class II Medical Device Registration , Shenzhen Class II Medical Device Registration Online Application Process

About Hong Kong Xintong

Hong Kong Xintong focuses onGuangdong and Hong Kong license plates、Shenzhen Hazardous Chemicals Business License、Shenzhen labor dispatch licenseandShenzhen Charity Foundationapplication services，Assist customers to applyShenzhen travel agency business license、Shenzhen pawn shop business license、Shenzhen auction house license and other mainstream domestic financial licenses，Support enterprises to achieve compliance expansion of cross-border financial business。Also availableODI overseas investment registration、International travel agency registration and other services，Help enterprises expand their presence in international markets。Provide one-stop compliance solutions for enterprises。To learn more，Please contactHong Kong Information Communications Consultant。