Drugdu.com expert's response:

Exporting medical devices requires a series of documents to ensure the legitimacy and safety of the products, as well as compliance with the relevant regulations and requirements of the importing country. Below is a detailed list of required documents:

Ⅰ. Corporate Qualification Documents

Business License: Certifies that the exporting enterprise has legal operating qualifications.

Medical Device Operation License: If the enterprise engages in medical device operations, it must provide a Medical Device Operation License issued by the National Medical Products Administration. However, please note that for certain categories of medical devices, if their safety and effectiveness are not affected by the distribution process, they may be exempt from operation registration.

Medical Device Production License: If the enterprise produces medical devices itself, it must provide this license to prove its qualification to produce medical devices.

Identification Documents of the Legal Representative or Business Responsible Person: Provide copies of valid identification documents such as ID cards or passports.

Organization Code Certificate and Tax Registration Certificate: Provide copies of these certificates and ensure their validity.

Ⅱ. Product-Related Documents

Medical Device Registration Certificate or Filing Certificate: Medical devices produced within China must obtain a product registration certificate or filing certificate to prove the legality of the product.

Product Quality Inspection Report: A product quality inspection report issued by a qualified medical device inspection institution, proving that the product meets relevant standards and requirements. This can be a self-inspection report of the enterprise or a report from a third-party testing institution.

Product User Manual: Provides detailed information on the product's purpose, usage, precautions, etc., ensuring that the product can be used safely and effectively. The product user manual is an important reference for the importing country's customs and importers to understand the product.

Free Sales Certificate (FSC): Certifies that a certain medical device product is legally sold in the manufacturing country and complies with local laws and regulations. For enterprises intending to export medical device products to international markets, the Free Sales Certificate is not only a necessary document for customs clearance but also enhances the importing country's trust in the product's safety and reliability.

Product Technical Documents: Include detailed product technical documents such as product descriptions, performance parameters, design drawings, manufacturing processes, etc.

Quality Management System Documents: Such as ISO 13485 certificates, internal audit reports, etc., proving that the enterprise has stable production and quality control capabilities.

Clinical Trial Data, Safety Assessment Reports, and Other Relevant Certification Documents: For medical devices requiring special approval or registration, these documents may be required.

III. Export Trade Documents

Export Contract: A detailed sales contract signed with foreign buyers, including product descriptions, quantities, prices, delivery methods, etc., which is the basis for both parties' transactions and an important document for export customs clearance.

Proforma Invoice: As a voucher for the importer to pay the goods and for the exporter to collect payment, it lists the detailed information and value of the goods. The Proforma Invoice is a common payment and collection voucher in international trade.

Packing List: Lists in detail the models and quantities of medical devices in each packaging box, ensuring the completeness and accuracy of the goods. The Packing List is an important basis for customs to verify the goods during export customs clearance.

Commercial Invoice: Lists in detail the goods' details, value, and other information, which is an indispensable document in international trade. The Commercial Invoice is an important basis for the importing country's customs to estimate and tax the goods.

Bill of Lading or Air Waybill: As an important voucher during the transportation process, it proves the transportation method and carrier information of the goods. The Bill of Lading or Air Waybill is a legal document for the goods during transportation and an important document for export customs clearance.

Ⅳ. Other Necessary Documents

Registration Form for the Export Sales Certificate of Medical Devices: Fill out this form according to the requirements of the target country/region.

Export Sales Certificate of Medical Device Products: If the enterprise has already obtained an export sales certificate for medical devices in China, a copy of the certificate must be provided.

Commitment Letter for the Authenticity of Materials: Provide a commitment letter written by the enterprise regarding the authenticity of the materials and stamped with the enterprise's official seal.

Certificate of Quality Credit Rating of the Manufacturing Enterprise: The original or a statement issued by the enterprise stating that it was not included in the list of Class C enterprises with quality credit issues in the previous year and is willing to bear legal responsibility for any falsehoods, proving the enterprise's quality credit status.

Export License: Some countries/regions may require an export license for exporting medical devices. The Export License is an important means for the exporting country to supervise exported goods and an important basis for the importing country's customs to release the goods.

Certificate of Origin: Certifies the production location and manufacturer of the product, helping the importing country understand the production situation of the product and also helping to enjoy specific trade benefits or avoid certain trade barriers. In some countries/regions, a Certificate of Origin may be required for import customs clearance.

Transport Insurance Documents: Purchase transport insurance for exported medical devices to ensure compensation for losses or damage during transportation.

Please note that specific export documentation requirements may vary by country, region, and type of medical device. Therefore, it is recommended to consult with professional import and export agents or local customs before actual operation to ensure that all necessary documents are prepared.