Register a medical device company and handle Class II filing on your behalf

Our company can register a medical device company and handle Class II filings on our behalf，There are many cases of Mr. Deng from Hong Kong Information Communication Co., Ltd.，There are 500 companies with registration experience in Shenzhen area，Four hundred companies in Guangzhou have registered Class II cases，This is usually done together with the registered medical device company.，The difficulty of agency application and preparation of materials for Class II medical devices are relatively simple compared to Class III medical devices.，Just provide product-related information, site-related information and personnel qualifications.，If there are Class II in vitro reagents, you only need a laboratory technician.，Shenzhen Hong Kong Xintong Deng Sheng is professional, efficient and fast

cost

transparent，Enterprises in need can contact us at any time.，Normally it takes three days to complete。

Registered medical device company handles Class II filing materials：

1. Copy of enterprise business license(Verify original)；
2. The identity of the legal representative of the enterprise and the person in charge of quality management、Copies of academic qualifications or professional titles and resume；
3. Identity of enterprise quality management personnel、Copy of academic qualifications or professional title；
4. Enterprise organization structure and functions or functions of full-time quality management personnel；
5. Business premises、Geographical location map of warehouse address、Floor plan and lease agreement；
6. Enterprise product management quality management system documents、Work procedures (in vitro diagnostic reagent wholesale companies only) and storage facilities、Device catalog；
7. Authorization statement of the person in charge and other explanatory materials；Registered medical device company handles Class II filing on behalf of the company

Require

：1.Have a quality management organization or full-time quality management personnel that is suitable for the business scale and scope of business。

Quality management personnel should have relevant professional academic qualifications or professional titles recognized by the state；

1. Have a relatively independent business location that is commensurate with the business scale and scope of business；
2. Have storage conditions suitable for the business scale and business scope，Including products that comply with the characteristics of medical devices

Require

storage facilities、equipment；

1. A sound product quality management system should be established，including procurement、Incoming goods acceptance、Warehousing and storage、Warehouse review、Quality tracking system and adverse event reporting system, etc.；
2. Should have technical training and after-sales service capabilities suitable for the medical device products it operates.，Or agree to have a third party provide technical support。

Hong Kong Xintong International Mr. Deng is a Class II medical device registration agency with a certain scale in Guangdong area.，Mr. Deng, the second-category filing specialist, has six years of relevant industry experience.，always on price、Maintaining industry-leading speed

Advantages

，Company lawyers、Audit and other departments，Check the company，Able to tailor effective solutions to problems for customers。

Mr. Deng’s company has a systematic service system，Able to accept client entrustments while，Refined division of labor，Completion of the second-category registration qualification application in a relatively short period of time，Now I have a Class III medical device qualification transfer in hand，It is recommended that we need to have a more in-depth understanding of the registration and handling of Class II medical devices.，Registered medical device company handles Class II filing，Conditions and procedures for applying for Category II registration and Category III license qualifications，Customers who transfer Class III medical device license conditions and other related matters，You can contact us directly to find out more，For details, please call Hong Kong Information Communication -。

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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。