The rumor of banning the export of masks was spread some time ago, and there is no explicit ban on the export of masks. The following chart, the enterprise also feedback can be normal export masks.
So, what exactly is needed for the export of masks?
Based on the National Medical Device Classification Catalog, Class I requires a filing certificate, Class II requires a registration certificate, and operating companies provide a business license.
One, the export of medical devices required by the relevant qualifications
● Engaged in the production of Class I medical devices, by the manufacturer to the municipal people's government of the location of food and drug supervision and management department for the record;
● Engaged in the production of Class II, Class III medical devices, the production of manufacturers to the people's government of the province, autonomous region and municipalities directly under the Central Government of the food and drug supervision and management department For the production license;
● Business Class I medical devices do not need licensing and filing;
● Business Class II medical devices for the record management, for the record of medical equipment business vouchers;
● Business Class III medical devices for licensing, for the business license of medical devices.
Reply "medical device" in the background of the public number to download the "Medical Device Classification Catalog".
Specifically, you can view the "supervision and management of medical devices regulations", "supervision and management of the production of medical devices" and "supervision and management of the operation of medical devices"
Medical masks belong to the second class of medical devices, should be in the scope of the business, to obtain a medical device registration certificate/medical device production license/medical device business filing qualifications, import and export business rights.
Used for sales export can be declared by general trade, it is recommended to upload a declaration list.
Second, non-medical masks export declaration
Non-medical masks export declaration, indicating "non-medical:
1. invoice, packing list
2. test reports and certificates of conformity
3. Customs and Excise Department required to add other explanatory documents
4. destination country customers/customs need Other documents
Three, medical masks export customs clearance
Medical masks export customs clearance, the remarks column enter "epidemic prevention materials and certificate number
1. invoice, packing list
2. Medical Device Business Record Certificate
3. test reports and certificates of conformity
4. Other documents required to supplement the description of the documents
5. The destination country customers / Customs need other documents
Four, an important reminder
1. Manufacturers exporting medical devices, should first apply for the export of products for the record, the export of sales certificates should be set up and save the file of exported products. The content includes the "medical device product export sales certificate" and "medical device export record form", the purchase contract, quality requirements, inspection reports, certificates of compliance, packaging, labeling, customs declaration, etc., in order to ensure that the product export process can be traced.
2. The production of medical devices for export should ensure that its production of medical devices in line with the requirements of the importing country, and product information to the location of the municipal food and drug supervision and management department for the record.
3. Production enterprises to accept foreign enterprises commissioned the production of medical devices marketed and sold outside the country, should obtain third-party certification of the quality management system of medical devices or similar products within the territory of the production license or record.
4. Unqualified three products can not be exported normally no matter what trade mode.
5. Declared as epidemic prevention materials, exported in accordance with the inspection instructions for customs clearance, according to the Customs on-site implementation of the requirements of the inspection to provide quality inspection reports, and can provide three certificates are complete.
Fifth, related to the handling of the site related to the handling of the site:
1. Medical equipment export record
Consulting telephone:
0755-12315/0755-88101552
2. Medical equipment products export sales certificate
Consulting telephone:
0755- 12315/0755-83070816
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