1, export customs clearance process
1) Preparation of information
Determination of the category of medical devices The State Drug Administration of the new coronavirus test kits to determine the management of the category of the third class of medical devices. New coronavirus test kits must obtain the "Chinese People's **** and the State Medical Device Registration Certificate."Medical Device License"
For the export of the product of foreign trade operators must obtain "Medical Device License".2) Customs declaration
Application for approval of export of special goods through the Customs Entry-Exit Special Goods Sanitary and Quarantine Supervision and Control System to the Customs directly under the location of the factory to submit an application. Provide medical device export customs broker documents Application Form for Sanitary and Quarantine Approval of Special Articles for Entry/Exit The descriptive material of special articles for export includes the name of the special articles in English and Chinese, the category, the composition, the source, the use, the main sales channels, the exporting country or region, and the distributor. Proof of sale The export of biological products for the prevention, diagnosis, treatment of human diseases, human blood products, should provide drug supervision and management departments issued by the sales certificate. Inspection and quarantine processing time and place: The export of new coronavirus test kits shall be exported to the customs agent or 7 days before shipment for inspection. The declaration should, in principle, the place of declaration to the customs where the kit factory to apply for exit inspection and quarantine procedures. After passing the inspection, the Customs and Excise Department issued an electronic bottom of the export inspection and quarantine. Provide documents foreign trade contracts, letters of credit, invoices, packing lists and other necessary documents. The export of goods must be qualified by the producer or operator inspection and attached inspection and quarantine certificate or test report. The export of special goods health and quarantine approval/certificate of cancellation.2, each country's access to testing reagents
U.S. FDA
Pre-market report [Premarket Notification, 510(k)] The pre-market report is the product manufacturer to FDA A premarket report is a report submitted by the manufacturer of a product to the FDA to demonstrate that the product is safe and effective. The report contains the following information: Methodology: e.g., radioimmunoassay; Analyte: e.g., Rheumatoid Factor (R)F; Specimen type: e.g., whole blood, serum, urine; Type of test: e.g., qualitative, quantitative; Type of product: e.g., instrument, reagent; Purpose of the test result; Performance data: e.g. Accuracy, specificity, sensitivity, and precision; Product package labeling and instructions: including purpose of use, specimen handling, interpretation of results, operating procedures, quality control, rationale, and performance indicators (sensitivity, precision, etc.). The FDA requires that reagents be manufactured under a quality management system. The predecessor is the Good Manufacturing Practice (GMP), which ensures the quality of different batches of products. In vitro diagnostic reagents production quality management follows the ISO9000 standard, medical laboratory management has ISO/DIS15189 standard; Participating in the export of companies to the United States need to fill out the FDA2891 form for business registration. At the same time, the exported product is registered with the FDA by completing FDA Form 2892. At the same time, at least 90 days before the product is marketed in the U.S., a 510(K) application is submitted to the FDA for review; Requirements in the case of EUA (Emergency Use Authorization) Companies are required to submit a request for EUA review of their products to the FDA. The FDA issued a new regulation on February 29, 2020, which allows test kits to be sold to specific CLIA (Clinical Laboratory Improvement Amendments) laboratories in the United States, such as Nelson Labs, and then these laboratories can do some validation experiments and report them to the FDA within 15 days, prior to obtaining EUA authorization. After obtaining approval, these kits can be used to carry out the test, the latest FDA documents provide that as long as the kit products declared FDA's EUA application and acceptance of the review, then it can be sold to any U.S. laboratories; or sold to the U.S., must be submitted within 15 days of the EUA application and through the acceptance of the application. (This applies to the current state of the global CKP epidemic).EU CE
The new coronavirus test reagents belong to Appendix 11, Category A (microbial antigens, antibodies, nucleic acid detection reagents, blood grouping reagents). EU regulations, from December 7, 2005 onwards, all in vitro diagnostic products marketed in the EU to have the European certification CE mark; Companies must obtain quality confirmation system (Quality Assurance Systems), the certification process includes ISO9000 and NE46000 series based on the quality system certification, including the design of the product file, The certification process includes quality system certification based on the ISO9000 and NE46000 series, which includes testing of product design files, types, and batches; The producer's quality system must be tested and evaluated by a test and evaluation organization, including testing of design files, product types, and so on. Products used to assess the safety of blood products are also subjected to the so-called "Common Technical Specification" (CTS) test, which evaluates their performance indicators. In addition, testing and evaluation organizations are required to conduct inter-laboratory batch testing of high-risk products; To ensure that products comply with the requirements of the IVDD, manufacturers must register their companies in their home countries, and companies from outside the European Union (EU) should register as commercial agents in the EU. Registration information includes: registered name and address, information on reagents and calibrators and QCs and any significant changes and discontinuations, correct identification of reagents, instruments, apparatus, equipment and systems, analytical and diagnostic parameters, results of performance evaluations and certificates, and new product announcements.Japan
In Japan, in vitro diagnostic products and medical devices are managed in the same department. In the registration of in vitro diagnostic drugs are divided into two categories: Category 1: products for new tests; Category 2: products for existing tests, which are divided into two parts: 2-A and 2-B. 2-A: items of greater importance in health and health care. In-vitro diagnostic products for infectious disease testing; In-vitro diagnostic drugs for blood group determination; In-vitro diagnostic products for genetic testing of pathogens; In-vitro diagnostic products for genetic testing of human beings; In-vitro diagnostic products for existing tests, but with a new measurement principle. In addition, in vitro diagnostic products with new clinical diagnostic significance whose sensitivity indexes are not included in the scope of nationally registered products are also included in the scope of 2-A. 2-B: Items other than those listed above. In Japan, diagnostic reagents are classified as pharmaceutical products, the competent authority is the Ministry of Health, Labor and Welfare, subject to the Pharmaceutical Affairs Law related to the regulation of the entry of customs clearance, you need to submit a copy of the "Pharmaceutical Manufacturing and Distribution License (Manufacturing License or a similar production record certificate)", as well as "Pharmaceutical Manufacturing and Distribution Approval" (or certification or record certificate). (or certification or filing certificate)".South Korea
Medical devices access to South Korea need to pay attention to the KGMP certification, medical devices are divided into I ~ IV class. Class I medical devices: the management of these products is relatively loose, Korean local and foreign companies can simply register online in the MFDS. For Class II~IV medical devices, they must pass the comprehensive review by the Korean medical device authorities before entering the Korean market. All Class II~IV medical devices exported to Korea must have complete technical documents, mainly including: System certificate issued according to ISO 13485; Product specification; Product leaflet; Product Raw material test reports; Product packaging; Product validity documentation (shelf-life verification report); Product performance test reports; Clinical reports (if applicable); Software documentation (if applicable); Electrical safety and electromagnetic compatibility test reports (if applicable); Biocompatibility test reports (if applicable). Only Class I and Class II medical devices can be submitted to the manufacturer's self-test report. For all other categories, the test report must be conducted in Korea or at an internationally recognized laboratory. Since April 2012, MFDS (Korea Food and Drug Administration) has been conducting on-site audits of foreign manufacturers. On-site audits are required for all but Class I medical devices. The application for MFDS audit is similar to the domestic registration system assessment application, also need to provide a series of information, KGMP audit need to provide more information, including: company profile; product registration certificate; staff roster; production product list; product specifications; according to the ISO13485 issued by the system certificate. List of equipment; Supplier information; Quality manual; Audit results from other organizations; Main product records. The first step is to submit the information to the Korean Medical Device Quality Management Accreditation Organization (MFDS) for review, which takes about 30 days. The MFDS on-site auditing standard for manufacturers is the Medical Device Manufacturing and Quality Management Standard, which is very similar to ISO 13485. It can also be said that the KGMP on-site audit is based on the ISO 13485 audit. After 30 days of submitting the MFDS information, the medical device quality management accreditation organization will send 2~3 auditors to the enterprise on-site audit, the audit time is 3~5 days.Australia
Registered by the Australian TGA, the MFDS is compliant with AS/NZS 1716:2012, which is the standard for respiratory protection devices in Australia and New Zealand. Australia's medical devices are classified into Class I, Is and Im, IIa, IIb, III, the classification of the product is almost the same as the EU classification, if the product has been awarded the CE marking, the product category can be classified in accordance with the CE classification. (Previously, some customers have asked if CE certification can not do TGA? Because the CE certification compared to the TGA level is higher, theoretically it can be.) Australia adopts a low-risk enterprise self-assessment, high-risk approval by the government, listed in different catalogs of products to implement different management, highlighting the key management of high-risk products. ARTG divides medical devices into three categories of management, registration (Registrable), record (Listable) and exemptions, except for express exemptions, after review and approval of the product can be sold in the market. Note: All countries of access to certification such as CE marking, must be designated by the importing country's certification body issued a certificate of authentication.