Import and export process of medical equipment import and export agent

First, the import of medical equipment needs to have the qualifications: (a) imported medical equipment units should have the qualifications

1, medical equipment business license;

2, business license [operating range of sales of medical equipment license];

3, import and export rights [if you can not find a qualified import and export of medical equipment import and export companies import and export companies

(two) documents required to be provided for the import of medical equipment:

1, the State Food and Drug Administration issued the registration certificate of imported medical equipment and medical devices registration form;

2, belongs to the "implementation of the compulsory product certification catalog" medical equipment, should provide the Chinese Compulsory Certification (3C);

3, some equipment need to apply for automatic import license [O];

4, equipment photos, nameplate, technical parameters, end use, Chinese instructions etc.;

5, import contracts, invoices, invoices;

6, other materials need to be added.

Two, medical equipment import customs clearance process:

1, foreign suppliers delivery;

2, sea to the domestic terminal or air to the airport; to the port after the shipping company (Airlines) to send the notice of arrival;

3, with the arrival notice and bill of lading to the shipping company for a single;

4, according to the regulatory requirements of the product, according to the requirements of the Commodity Inspection Bureau for the inspection and quarantine procedures;

5, customs declaration (with bill of lading, customs declaration, customs declaration form, etc. or product regulatory requirements for other documents)

6, accepted customs; customs valuation (to accept the declared value through or designated by the customs to query the price negotiation of value or the customs system);

7, a tax (tax tariff, value-added tax, tax payment);

8, dock lift;

9, smooth clearance, release, transport to the designated location.

Three, imported medical device registration certificate for the required information (valid for four years, 6 months before the expiration of the validity of the application for re registration)

1, overseas medical device registration application form

Form for registration of import medical device Application

2, medical equipment production enterprise qualification certificate

Qualification certification for medical device manufacturing enterprise. Legal

3, a copy of the applicant's business license and production companies to grant the proxy registration of the power of attorney

Copy of applicant A s business license and proxy for registration entrusted by the Manufacturing enterprise

4. The product is approved or approved by the competent department of medical equipment in the overseas government as a medical device to enter the market of the country (region).

Proving that the Documents product can enter a certain country as (region or) medical

Approved or accepted Device by the medical device competent departments of overseas governments

5, applicable product standards (and instructions)

Product standard and instructions Applicable

6, medical device specification

For medical device Specification

7, medical device testing institutions issued a product registration test report (applicable to second categories, third types of medical devices)

Report on Test product registration given by medical device inspection institutions applicable Class II and Class III medical device (to)

8. Clinical trial data of medical devices

Device clinical trials report. Medical

9, the product quality guarantee issued by the production enterprise

Product quality guarantee issued by the manufacturer letter that the quality of the product to be registered for sale in China is exactly the same as that of the product marketed in the country (region) of origin.

10, the production enterprises in China designated agent of the letter of attorney, the agent's commitment and business license or business license registration certificate

Of assigned Proxy agent of the manufacturer enterprise in China written Commitment of the agent and business license or registration certificate of the agent.

11, in the designated service agencies in China's power of attorney, commissioned by the commitment of the organization and the qualification documents

Of Authorization Letter for designated after-sales service agency in China and Letter of Promisa and business license of the authorized agency.

Four, imported medical equipment exemption conditions and procedures

1, medical equipment import duty free condition

Non - profit medical, scientific research, teaching unit for the rehabilitation of the body, scientific research, teaching of imported equipment, in accordance with the conditions of exemption from import duties.

2, imported medical equipment tax exemption application process

[1] to the project authorities to apply for "the state to encourage the development of internal and foreign investment projects confirmation", with confirmation to the Customs for tax relief procedures.

[2] approval process for the approval of the Customs for the approval of the tax reduction and exemption project:

1, to apply for units to provide tax filing documents required for the record;

2, the applicant to fill out the "tax exemption certificate for the application form", and to pre recorded center;

3, the application unit to hold the required documents and pre registration form submitted to the Customs for the first instance;

4, the Customs for three levels of approval.