1. Establishment of ISO 13485 quality management system
2. Preparation of technical documentation (TCF) (application form provided by the licensing agency)
3. Preparation of test reports (based on the requirements of the EN14683 test, mainly to provide biological routine three, bacterial filtration efficiency, respiratory resistance, splash resistance and sterilization validation report, etc.
4. Sterilization verification report, etc.)
4. Audit by the notified body
5. Obtain ISO13485 certification and CE certificate
6. Designate the EU authorized representative to complete the registration (submitted by the designated EU authorized representative for registration)
Non-sterile medical masks certification process:
1. Preparation of the technical documentation (TCF) (the issuing body) Provide application form)
2. Prepare test report (test according to EN14683 requirements, or provide meltblown fabric performance test report and nonwoven fabric biology test report)
3. Prepare Declaration of Self-Conformity (DOC)
4. Submission of registration by the designated EU Authorized Representative (Designated EU Authorized Representative submits the registration in his/her own country)
5. p>5. Issuance of CE-PPE certificate by the issuing authority (the issuing authority with the ability to issue PPE evaluation and issuance of certificates)
EU masks are mainly divided into personal protective masks (PPE) and medical masks, of which PPE is based on the standard EN149, and the protection of the risk of low-to-high and is divided into three categories of FFP1, FFP2, FFP3; medical masks are managed in accordance with the first class of medical devices, which are divided into class I non-medical devices. Medical device management, divided into Class I non-sterile masks and Class I sterile masks, based on the standard EN14683, its BFE, breathing resistance and anti-splash ability is divided into Type I, Type II, Type IIR three categories.
Legal basis:
"The Chinese People's Republic of China and the State Import and Export Tariff Regulations"
Article 10 of the imported goods originating *** with the application of the most-favored-nation clause of the members of the World Trade Organization, the imported goods originating in the Chinese People's Republic of China and the State signed a bilateral trade agreement with the provisions of the most-favored-nation clause. The most-favored-nation tariff rate shall be applied to imported goods originating in countries or regions that have signed bilateral trade agreements with the People's Republic of China and the People's Republic of China that contain provisions for reciprocal most-favored-nation treatment. Goods imported from countries or regions that have signed regional trade agreements with the People's Republic of China that contain tariff preference clauses shall be subject to the tariff rates of the agreements. Imported goods originating in countries or regions that have signed trade agreements with the People's Republic of China that contain special tariff preference provisions shall be subject to preferential duty rates. Imported goods originating in countries or regions other than those listed in the first, second and third paragraphs of this Article, as well as imported goods of unknown origin, shall be subject to ordinary rates of duty.
Article XI of the most-favored-nation tax rate applicable to imported goods have a temporary tax rate, should be applied to the temporary tax rate; the agreement rate, preferential tax rate applicable to imported goods have a temporary tax rate, should be applied from the lower tax rate; applicable to imported goods, the ordinary tax rate, does not apply to the temporary tax rate. The export tax rate applicable to export goods have a temporary tax rate, should be applied to the temporary tax rate.
Article XII in accordance with state regulations for the implementation of tariff quota management of imported goods, tariff quotas, tariff quotas within the tariff quota rate; tariff quotas outside the tariff quota, the tax rate shall apply in accordance with the provisions of Article 10, Article 11 of these Regulations.
Article XIII in accordance with relevant laws and administrative regulations on imported goods to take anti-dumping, countervailing, safeguard measures, the application of its tax rate in accordance with the "Chinese People's *** and State anti-dumping regulations", "Chinese People's *** and State countervailing regulations" and "Chinese People's *** and State safeguard measures regulations" in accordance with the relevant provisions of the implementation.