Share with you what is needed for medical device export?

Compared with general goods, the export of medical devices is more troublesome, but many people want to do business in this area, how to do it? First of all, import and export pharmaceutical projects must meet the national medical import and export list, and meet the listing requirements of the importing country.

The export of medical devices must first have the basic export qualification conditions for the production enterprises and their products before they can declare the export of products to the Chinese Customs. Secondly, various regions abroad also have corresponding entry thresholds for medical device products, and these two conditions are the basic conditions for exports. Here, the above two conditions will be combined with the medical device category.

1. Matters required by export enterprises.

1. Registration of Foreign Trade Operators (Bureau of Commerce)

2. Customs Registration Certificate (Customs)

3. Electronic port IC Card (Customs)

4. Handling foreign exchange registration and filing (SAFE)

5. Apply for tax refund recognition (IRS)

6. Open a foreign exchange account (bank)

7. Commodity Inspection Bureau registration and filing (Commodity Inspection Bureau) - According to the product HS code to determine whether it is a regulated product, not necessary

Second, product export qualification

2.1 Certificate of export sales

The sales certificate of medical device products is approved by the Food and Drug Administration Department (SFDA) for medical device export trade enterprises. For products that have obtained a medical device registration certificate, submit the following documents to SFDA:

a. Registration form of export sales Certificate of medical device products (original with official seal and signature of legal person)

b. Medical Device Manufacturer's License for Export products (copy)

c. Medical Device Registration Certificate for export products (copy)

d. Business license of export enterprise (copy)

e. The applicant's self-assurance statement (the original is stamped with the official seal of the company and the signature of the legal person, this statement is only needed when obtaining evidence) the copy of the certificate submitted shall be stamped with the official seal of the enterprise to which the certificate belongs.

For products that have not obtained a medical device product registration certificate, submit the following documents:

a. Registration form of export sales Certificate of medical device products (original with official seal and signature of legal person)

b. Business license of the manufacturer (copy)

c. Business license of export enterprise (copy)

d. The applicant's self-assurance statement (the original is stamped with the official seal of the company and the signature of the legal person, this statement is only needed in the collection of evidence) the copy of the certificate submitted shall be stamped with the official seal of the enterprise to which the certificate belongs.

2.2 Operation and production qualification

If an enterprise develops and operates a class II medical device, it is necessary to handle a class II medical device company operating record, three types of medical devices for medical devices operating license, and for the export of production technology enterprises, it is necessary to handle the corresponding medical device registration certificate and production license according to the type of medical devices in China. This is a necessary prerequisite for the sale of the main export commodities of medical device products.

2.3 Import and export rights

Import and export right refers to the qualification of import and export enterprises to carry out import and export business, apply for import and export right of enterprises only in the municipal Bureau of Commerce, inspection and quarantine Bureau, electronic port, urban customs and other relevant departments approval, after getting the above departments to approve all kinds of certificates, the enterprise is really have the right to import and export, you can engage in import and export business.

Iii. Overview of foreign access permits

1. Export to Japan for PMDA registration

2. Export to Korea KFDA registration

3. Export EU CE certification

4. FDA registration for export to the US

5. CMDCAS for medical device export to Canada

6. TGA registration for export to Australia

Each country has different requirements for medical device product access, and needs to be analyzed on a case-by-case basis.