Project Description

What qualifications are required for import and export of Covid-19 Rapid Test Kit

China has made a significant contribution in the fight against viral infections, with many countries using medical items such as masks and testing kits that are made in China.

China has been able to carry the heavy burden with its own efforts, covering one province and one country.

In addition to the mask, China’s production of testing kits, has become a “pop” of countries scrambling to buy, the global daily consumption of testing kits reached 500,000 to 700,000, dozens of countries to submit orders to China, hoping to import a large number of Chinese testing kits, have to sigh at China’s strong productivity!

In order to meet the needs of countries to prevent and control the epidemic, China’s 12 enterprises with product registration certificates are in full production, and the daily production is only 341,600 units, which means that the production of China’s 12 enterprises is still unable to meet global needs.

At present, the new coronavirus 2019-nCoV nucleic acid detection kit developed under Huada Genetics, which is widely used in China, has been sent to the UK, France, Switzerland, Austria, Georgia, India, Japan, the US and other countries and regions.

Export declaration process

Preparatory documents:

1、Determine the category of medical devices

The State Drug Administration identified the new coronavirus testing kit management category as a Class III medical device.

2、”Medical Device Production License” and “Medical Device Registration Certificate”.

Similar to masks, manufacturing units are required to provide a Medical Device Manufacturing License. The new coronavirus detection kit must obtain the “People’s Republic of China Medical Device Registration Certificate”.

3、The Medical Device Business License

For the export of the product’s foreign trade business unit shall obtain a “medical device operating license”.

4、”Certificate of export sales of medical equipment products”.

New coronavirus test kits shall be exported to the Drug Administration for “medical device products export sales certificate”.

Customs declaration

1.Application for approval of export special goods

Applications are made to the direct customs of the factory site through the customs entry/exit special goods sanitary and quarantine supervision system.

2. Provide medical device export customs broker documents

Application Form for Sanitary and Quarantine Approval of Entry/Exit Special Articles

3. Descriptive material on special items for exit

Include the name, category, composition, source, use, main sales channel, country or region of export, distributor, etc. of special articles in English and Chinese.

4.Sales certificate

Biological products and human blood products exported for the prevention, diagnosis and treatment of human diseases shall provide a certificate of sale issued by the drug supervision and management department.

Inspection and quarantine

  1. Time and place of processing

▲Export of novel coronavirus test kits must be declared 7 days before export or shipment by the export customs broker.

▲In principle, you should apply for exit inspection and quarantine procedures at the customs office where the kit factory is located. After passing the inspection, the customs issued the export inspection and quarantine electronic ledger.

  1. Provision of documents

▲The necessary documents such as foreign trade contracts, letters of credit, invoices, packing lists, etc.

▲Outbound goods must be inspected by the producer or operator and accompanied by an inspection and quarantine certificate or test report.

▲Sanitary and quarantine approval/cancellation of special articles for departure.

Access conditions for Covid-19 Rapid Test Kit in various countries

 

US FDA

1.Pre-market reports

[Premarket Notification, 510(k)]

A pre-market report is a report submitted to the FDA by the manufacturer of the product that certifies that the product is safe and effective. The report contains the following information.

▲Methodology: e.g., exemptions

▲Analysis (testing) items: e.g., rheumatoid factor (R)F

▲ Specimen type: e.g. whole blood, serum, urine

▲Type of test: e.g. qualitative, quantitative

▲Product type: e.g. instrument, reagent

▲The purpose of the test results

▲Data from performance tests: e.g. accuracy, specificity, sensitivity and precision

▲Product packaging labels and instructions: including purpose of use, specimen handling, interpretation of results, operating procedures, quality control, principles and performance indicators (sensitivity, accuracy, etc.)

2. FDA requires the production of reagents to follow the quality management system, formerly the production quality management standard (GMP), to ensure the quality of different batches of products. The production quality management of in vitro diagnostic reagents follows ISO9000 standard, and the medical laboratory management has ISO/DIS15189 standard.

3. To participate in the export to the United States companies need to fill out the FDA 2891 form for business registration. The exported product is also registered with the FDA by filling out FDA Form 2892. Also submit the 510(k) application to the FDA for review at least 90 days prior to the product’s launch in the United States.

4. EUA (Emergency Use Authorization) case requirements: companies need to submit to the FDA to apply for EUA review of the product, the FDA issued a new regulation on February 29, 2020, allows testing kits before the EUA authorization, can also be sold to the United States specific CLIA (Clinical Laboratory Improvement Amendments) laboratory such as the United States Nelson Labs, then these laboratories can do some validation experiments, and within 15 days after the declaration of FDA approval, can use these kits to start testing. (applicable in the current global neocoronary pneumonia epidemic).

EU CE

1、The new coronavirus test reagents belong to Appendix 11, Class A (microbial antigen, antibody, nucleic acid test reagents, blood type reagents). The EU requires that all in vitro diagnostic products marketed in the EU have the European CE Mark as of December 7, 2005.

2, the enterprise shall obtain the quality assurance system (Quality Assurance Systems), the certification process includes quality system certification based on ISO9000 and NE46000 series, including the product design file, type inspection and inspection of batch products.

3, the producer’s quality system must be tested and evaluated by the institution, including the design file, product type, etc. Products used to assess the safety of blood products are also subjected to the so-called “Common Technical Specification” (CTS) test, which evaluates their indicator performance. In addition, test evaluation agencies are required to conduct inter-laboratory batch tests for high-risk products.

4, in order to ensure that the product in accordance with the requirements of the IVDD, the production enterprise must carry out enterprise registration in its own country, the enterprise outside the EU, should be registered in the EU commercial agent. Registration information includes: registered name and address, information on reagents and calibrations and quality control substances and any significant changes and interruptions in marketing, correct identification of reagents, instruments, apparatus, equipment and systems, parameters for analysis and diagnosis, performance evaluation results and certificates, new product announcements, etc.

Japan

Japan regulates in vitro diagnostic supplies and medical devices in the same department. There are two categories of in vitro diagnostic drugs for registration purposes.

Category 1: New testing project products.

Category 2: Existing test item products, which are divided into 2-A and 2-B. 2-A: Items that are more important in terms of hygiene and health care.

(1) In vitro diagnostic supplies for the detection of infectious diseases.

(2) In vitro diagnostic drugs for blood group determination.

(3) In vitro diagnostic supplies for genetic testing of pathogens.

(4) In vitro diagnostic supplies for human genetic testing.

(5) In vitro diagnostic supplies for existing tests, but using new principles of measurement.

In addition, test sensitivity indicators are not included in the scope of nationally registered products, and in vitro diagnostic products with new clinical diagnostic significance are also included in the scope of 2-A.2-B: Items other than the above mentioned varieties.

In Japan, diagnostic reagents are classified as pharmaceutical products and are regulated by the Ministry of Health, Labour and Welfare, and are subject to the Pharmaceutical Machinery Act, which requires the submission of a copy of the “Pharmaceutical Manufacturing and Sales License (Manufacturing License or Similar Manufacturing Record Certificate)” and a copy of the “Pharmaceutical Manufacturing and Sales Approval Certificate (or Certificate or Record Certificate)” at the time of entry.

Korea

Medical device access to Korea should pay attention to KGMP certification, medical devices are divided into Ⅰ~Ⅳ categories.

Class I medical devices: The regulation of these products is relatively lenient, local and foreign companies can register online at MFDS.

For Ⅱ ~ Ⅳ medical devices, must be through the Korean medical device authorities to enter the Korean market after a comprehensive review, all exports of Korean Ⅱ ~ Ⅳ medical device products must have complete technical documentation, including.

(1) A system certificate issued in accordance with ISO 13485.

(2) Product specifications.

(3) Product brochures.

(4) Product raw material testing reports.

(5) Product packaging.

(6) Product validity documentation (shelf life verification report).

(7) Product performance test reports.

(8) Clinical reports (if applicable).

(9) Software materials (if applicable).

(10) Electrical safety and electromagnetic compatibility testing reports (if applicable).

(11) Biocompatibility test report (if applicable).

Only Class I and II medical devices can be submitted to the manufacturer’s self-test report. Test reports for other categories of products must be tested in Korea or at an internationally recognized laboratory.

MFDS (Korea Food and Drug Administration) began conducting on-site audits of foreign manufacturing companies in April 2012. Except for Class I medical devices, all others require on-site audits.

The application for MFDS audit is similar to the domestic registration system assessment application and requires a series of information, while KGMP audit requires more information, mainly including.

(1) Company profile.

(2) Product registration certificate.

(3) Staff roster.

(4) List of production products.

(5) Product specifications.

(6) System certificate according to ISO 13485.

(7) Equipment list.

(8) Supplier information.

(9) Quality manual.

(10) Results of audits by other bodies.

(11) Product master record. The first step is to submit the information to the Korean Medical Device Quality Management Accreditation Agency for review, which takes about 30 days.

The MFDS field audit standard for manufacturers is the Medical Device Production and Quality Management Standard, which is very similar to ISO 13485. It can also be said that KGMP’s field audits are based on ISO 13485 audits. 30 days after the submission of MFDS information, the medical device quality management accreditation body will send 2~3 auditors to the enterprise on-site audit, the audit time is 3~5 days.

Australia

Registered with the TGA in Australia and complies with Standard Specification: AS/NZS 1716:2012, which is the Australian and New Zealand standard for respiratory protection devices. Australia classifies medical devices into Classes I, Is and Im, IIa, IIb, III. The classification of products is almost identical to the EU classification, and if the product has been CE marked, the product category can be classified under CE. (Previously, some customers asked if they could not do TGA if they have CE certification, because CE certification is higher than TGA, theoretically it is possible.

The Australian Register of Therapeutic Goods (ARTG), which is administered by the TGA, classifies medical devices into three categories, Registrable, Listable and Exempt, with the exception of those products that are expressly exempted and subject to review and approval before being marketed.