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关于12号公告回应的热点问题Hot issues regarding the response to Announcement 12
Hot issues regarding the response to Announcement 12
1. For non-medical mask export contracts signed before April 26, does the manufacturer need to be included in the list of non-medical mask manufacturers that have obtained foreign standard certification or registration published by the Medical Insurance Association?
Answer: No. The export contract for non-medical masks signed before April 26 will be executed in the same manner as before the announcement. The manufacturer does not need to be listed in the list of non-medical mask manufacturers that have obtained foreign standard certification or registration issued by the Medical Insurance Association, but the export enterprise should submit it at customs The electronic and written exporter and importer jointly declare.
2. For the export of 5 types of medical materials such as new coronavirus detection reagents, medical masks, medical protective clothing, ventilators, infrared thermometers, etc., will announcement No. 5 continue to be implemented after the announcement of announcement No. 12?
Answer: Announcement 5 continues to be implemented. Announcement 12 is the further improvement and optimization of Announcement 5, and the two announcements are executed simultaneously. That is, if the 5 types of medical materials are exported in accordance with Chinese quality standards, a medical device product registration certificate approved by the drug supervision and administration department must be provided; if they are exported in accordance with foreign quality standards, the manufacturing enterprise should obtain the foreign standard certification or registered production announced by the Medical Insurance Association Enterprises in the enterprise list.
3. How can an enterprise enter the list of anti-epidemic materials manufacturers that have obtained certification or registration of foreign standards published by the Medical Insurance Association?
Answer: The Ministry of Commerce has specially issued the "Notice on Organizing the Work on the List of Enterprises for the Inspection and Confirmation of Conformity and Registration of Anti-epidemic Materials Produced in Accordance with Foreign Standards" on April 25, requesting local commercial authorities to organize voluntary declarations And review and confirmation work. The notice has been published on the website of the Ministry of Commerce.
4. For non-medical mask export contracts signed after April 26, the manufacturing enterprises have not entered the list of non-medical mask manufacturing enterprises that have obtained foreign standard certification or registration published by the Medical Insurance Association, can they be exported?
Answer: First of all, enterprises should make clear whether the exported products comply with Chinese standards or foreign standards. If the exporter and the importer agree that the products are exported according to foreign standards, the manufacturing enterprise shall be included in the list of non-medical mask manufacturing enterprises that have obtained certification or registration of foreign standards published by the Medical Insurance Association. If the exporter and the importer agree that the product is not exported according to foreign standards, and the manufacturer is not included in the list of non-medical masks of unqualified products and enterprises listed in the domestic market provided by the General Administration of Market Supervision, the relevant products are submitted in the case of a joint declaration Can be exported.
5. Medical material manufacturing companies do not have domestic medical device product registration certificates, and have foreign CE and FDA certificates (in the list of companies published by the Medical Insurance Chamber of Commerce), but the exporting country does not have a corresponding certificate, and the buyer ’s contract and relevant agreements have agreed to accept foreign quality Standards, how to deal with exports?
Answer: As long as both parties agree to accept foreign standards. The relevant standard is not necessarily the quality standard of the importing country (region).