What qualification is needed for exporting forehead temperature gun to Hong Kong?

The forehead temperature gun belongs to the second class of medical devices, if only do export sales, only need to handle the import and export rights with the second class of medical devices can be, if you do production, you need to apply for a medical device production license, medical device product registration certificate, there are a number of countries also need to provide the international certification, the European Union needs CE certification, the U.S. FDA certification, of course, if you do only do sales, it's not as complicated. Complex, only need to have the right to import and export and the second class of medical devices for the record, like the international certification of such, the general manufacturer will provide there.

For the second class of medical equipment business registration address requirements:

1, office area of not less than 40 square feet; (business building or storefront store);

2, warehouse area of not less than 15 square feet; (my company can provide) (three types of in vitro diagnostic reagents containing a single need for frozen warehouses);

3, containing three types of disposable supplies, then the requirements of the Office address and warehouse area together can not be less than 160 square feet;

If the warehousing entrusted to a third-party logistics company, you need to have a medical device license qualification of the logistics company can.

For the second class of medical devices business filing personnel requirements:

1, with medical equipment, medicine, pharmacy bachelor's degree or above, or intermediate or above technical title 1, as the quality responsible for

2, with high school education 2, as quality manager;

Medical device business filing certificate required application materials:

Medical device business filing certificate:

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1. Class II medical device business filing form

2. Business license and a copy of the organization code certificate

3. Legal representative, the person in charge of the enterprise, the person in charge of quality of the identity of the person, a copy of the certificate of academic qualifications or titles

4. Organizational and departmental setup instructions

5. Scope of business, the business mode of operation description;

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6. business premises, warehouse address of the geographic location map, floor plan, documents proving ownership of the house or a copy of the lease certificate issued by the housing leasing office;

7. business facilities, equipment directory;

8. business quality management system, work procedures and other documents directory;

9. proof of authorization by the operator.