China custom requirements - Medical materials export update 27/4/20

Issued on 29 Apr 20

Draft, Translation to Eng. version & issued by PGA.


This operation guide is updated on April 27, 2020 A) Customs requirements Medical materials declaration requirements Export medical products : 1. Meet the requirements of Announcement No. 5; 2. Compliance with Announcement No. 12: Obtaining foreign certification and being on the list of the Ministry of Commerce ( either one will do ) (The name of the medical material document / declared products should be in accordance to the medical device registration certificate, and the manufacturer on the registration certificate is allowed to export only if they are in the registration file of the drug regulatory bureau. Attach the website for ready reference if there is any query http://www.nmpa.gov.cn/WS04/CL2584/

Documents required for customs declaration: customs declaration slip, invoice, packing list, contract, customs declaration form (electronic declaration), medical device registration certificate, if it complies with Announcement 5, the old version of the export of medical supplies declaration, compliant with Announcement 12 - The latest version of the export medical materials declaration (with the domestic exporter seal), the manufacturer ’s business license, the manufacturer ’s production license, the manufacturer ’s entrusted agreement with the import and export party, and the ingredient declaration; Requirements for customs declaration of non-medical materials: (Non-medical mask manufacturers are not in the blacklist directory)

Non-medical export: First, meet foreign standards, and the production and sales units are in the Ministry of Commerce list; Second, meet domestic standards (including also comply with foreign standards), which can be directly declared. (You can take either one ) under both situations … must provide a joint statement in both Chinese and English from the importer and exporter, and both parties will verify whether they are on the blacklist of the General Administration of Market Supervision bureau. Document customs declaration: customs declaration draft, invoice, manifest, contract, customs declaration authorization (electronic authorization), manufacturer's business license, composition declaration, manufacturer authorization agreement for import and export business unit, non-medical materials export commitment (with Manufacturer's seal stamped ), non-medical exporters and importers jointly declare (with manufacturer's seal stamped );


(PGA China member get ready to assist for merchandising and global delivery, please email comm.mgr@pacificglobal.com; jackylok@pacificglobal.com if any request) B) Requirements for the export of anti-epidemic materials: Update: The product name on the certificate of epidemic prevention materials must be the same as the product name on the declaration, and must be marked with "non-medical XXX masks", such as non-medical disposable masks, medical protective masks, etc., to ensure the declaration of the product name and qualification If the products with the matching product name involve CE and FDA, only the enterprise (or the manufacturer ) registered the products on the white list is allowed. All products that are not on the list cannot bear the words CE or FDA. Non-medical materials export requirements: 1. The name of the manufacturing enterprise must be displayed on the product or packaging or certificate of conformity (English requires an operator ’s registration certificate); 2. Each packet/box of the goods must have a certificate of conformity (must be stamped), product Or the packaging or certificate must have: implementation standards, production batches, manufacturer name, manufacturer address, production date, expiration date, ingredient ratio;


Requirements for export of medical epidemic prevention materials: 1. Business license of production enterprise; 2. Medical device registration certificate; 3. Medical supplies declaration (the form cannot be left blank, the table header should not have the word template, and the official seal of the production and sales unit); 4. Medical devices are subject to production licenses; 5. The manufacturer's inspection report; 6. The name and model of the manufacturer and registration certificate must correspond to the customs declaration information, and the production company needs to be in the customs register (the registration number is only valid if the information of this production company can be found on the China FDA website); 7. Each small package/box of the goods must have a certificate of conformity (must be stamped), and the product or packaging or certificate of conformity must have: implementation standard, production batch, manufacturer name, manufacturer address, production date, validity period, Information such as the proportion of ingredients; C) At present, the inspection department affirms that below is for medical use : ① The outer packaging has Chinese and English words for medical use ; ② The domestic product standards implemented are medical standards;(Execution standard website address: http://www.gov.cn/fuwu/bzxxcx/bzh.htm); ③ The product bears the FDA or CE EN14683 sign ; D) the receipt of products must confirm the clear information elements of the goods: i. Confirm the purpose of the goods, medical or non-medical (the corresponding medical or non-medical information should be displayed on the goods); ii. The brand of the goods is not a “famous” brand ( if the brand is already registered …. It infringes patent law); iii. There must be a certificate of conformity in the goods. The outer packaging box (product name, model specifications, production batch number, production date, shelf life date, technical standards, inspection seal, manufacturer and other information is complete); iv. Be sure to confirm whether the manufacturer's information on the goods is consistent with the declaration information provided; v. The packaging must have retail packaging standards, not simple bulk, either standard color bags or standard cartons;


Announcement No. 12 of 2020 Export for medical use: First, meet the requirements of Announcement No. 5; Second, comply with Announcement No. 12 and obtain foreign certification and be included in the list of the Ministry of Commerce. ( either one is alright) Export for Non-medical use: First, only meet foreign standards, and the production and sales units meet the Ministry of Commerce list; Second, meet China domestic standards (including also comply with foreign standards), which can be directly declared. (either one is alright.) Both types must provide a joint statement in both Chinese and English from the importer and exporter, and both will verify whether they are on the blacklist of the General Administration of Market Supervision.

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