Requirements for export declaration of COVID-19 test kit imported from China

Commodity classification:
COVID-19 Detection reagents are classified as 38220090.

Inspection and quarantine of COVID-19 test kit imported from China:
 Apply for health and quarantine approval
The COVID-19 test kit is special items, which are subject to strict quarantine supervision by the customs. Before exporting reagents, you need to apply for sanitary quarantine approval of entry-exit special items, and obtain the “Entry / Exit Special Items Sanitary Quarantine Approval Form”.

Special Tips: For the purpose of epidemic prevention and control, special items such as vaccines, blood products, reagents, etc. used for prevention, treatment, and diagnosis of coronavirus pneumonia can be exempted from special entry and exit with the special approval documents issued by the provincial drug regulatory department Approval of items for health and quarantine.

Declaration of export legal inspection goods
The COVID-19 test kit is exported for legal inspection and needs to be subject to exit health quarantine. The consignor should use the “Entry / Exit Special Items Sanitation and Quarantine Approval Form” for declaration in a single window. After passing the comprehensive assessment of export inspection and supervision, the consignor shall obtain an electronic fund account.

Customs declaration
To declare a declaration in a single window, you need to fill in the electronic account number at the time of the declaration. The other standard declaration requirements are the same as those for masks and protective clothing.

Coronavirus detection reagent classification:
The COVID-19 test kit is an emerging product and belongs to in vitro diagnostic products. They are mainly divided into nucleic acid detection reagents and antibody detection reagents. In vitro diagnostic products are usually managed by medical devices in various countries.
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Access conditions for COVID-19 test kit in various countries

Product access conditions:

Imported COVID-19 test kit to the United States
The United States classifies IVD products into the category of medical devices and must obtain FDA certification from the US Food and Drug Administration before it can be sold in the US domestic market. New COVID-19 test kit belongs to the second category: pre-market reports are required, referring to microbiologically controlled (in vitro diagnostic products).

• 1. Report before listing
  [Premarket Notification, 510 (k)]
  The pre-market report is a report submitted by the product manufacturer to the FDA to prove that the product is safe and effective. The report contains the following information:

(l) Methodology: for example, the release-free method
(2) Analysis (detection) items: for example, rheumatoid factor (R) F
(3) Specimen type: such as whole blood, serum, urine
(4) Test type: for example qualitative and quantitative
(5) Product type: such as instruments and reagents
(6) Purpose of test results
(7) Performance test data: such as accuracy, specificity, sensitivity, and precision
(8) Product packaging labels and instructions: including the purpose of use, specimen processing, result interpretation, operating procedures, quality control, principles and performance indicators (sensitivity, accuracy, etc.)

• 2. The FDA requires the production of reagents to follow Quality System Regulations (QSRs), formerly known as Production Quality Management Regulations (GMP), to ensure the quality of different batches of products. The production quality management of in vitro diagnostic reagents follows the ISO9000 standard, and the medical laboratory management has the ISO / DIS15189 standard.
• 3. Companies involved in exporting to the United States need to complete the FDA2891 form for business registration. At the same time, the exported products are registered with the FDA by filling out the FDA2892 form. At the same time, at least 90 days before the product is marketed in the United States, submit the 510 (K) application documents for FDA review.
• 4. Requirements in the case of EUA (Emergency Use Authorization): The enterprise needs to submit an application to the FDA for EUA review of the product. 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 before they are authorized by the EUA. ), And then these laboratories can do some verification experiments, and within 15 days after applying for FDA approval, they can use these kits to start testing.
• The latest FDA documents stipulate that as long as the kit product declares the FDA’s EUA application and is accepted for review, it can be sold to any laboratory in the United States; or when sold to the United States, the EUA application must be submitted and accepted within 15 days. (Currently applicable under the spread of the global new coronary pneumonia epidemic).

Imported COVID-19 test kit to the EU
● 1. The European Union Standing Committee (General Affairs Council) was established on October 5, 1998 (The Directive on In Vitro Diagnostic Medical Devices, IVDD). IVDD divides in-vitro diagnostic products into two parts, a total of 4 categories: products that do not pose a direct threat to patients account for the main part, and only need to be self-proven by the producer, such as ordinary and self-tested; if there are problems with other products, they will Health poses a serious threat. These high-risk products are listed in Appendix 11 of IVDD and are divided into A and B categories. COVID-19 test kit belongs to appendix 11 class A (microbial antigen, antibody, nucleic acid detection reagents, blood type reagents). The EU stipulates that from December 7, 2005, all in vitro diagnostic products listed in the EU must have the European certification (Conformite Europeene, CE) mark.

● 2. The enterprise must obtain a quality assurance system (Quality Assurance Systems). The certification process includes ISO9000 and NE46000 series quality system certification, including product design files, type inspection, and batch product inspection. IVDD clearly requires producers to have a product-related, fully effective quality system. The establishment of the system can ensure that the entire production process follows the principle of ensuring quality. All elements of the process must be recorded in a systematic and orderly manner, such as quality procedures, plans, operations, and records.

● 3. The quality system of the producer must pass the inspection of the testing and evaluation agency, including the inspection of design files and product types. The products used to evaluate the safety of blood products are also subject to the so-called “Common Technical Specification” (CTS) test to evaluate their index performance. In addition, the testing and evaluation agency also needs to perform batch inspection between reference laboratories for high-risk products.

● 4. In order to ensure that the products comply with the requirements of IVDD, the manufacturing enterprise must register the enterprise in its country. Enterprises outside the EU should register commercial agents in the EU. Registration information includes registered name and address, information on reagents and calibrators and quality control materials and any important changes and information on discontinuation of marketing, correct identification of reagents, instruments, appliances, equipment, and systems, analysis of diagnostic parameters, performance evaluation Results, and certification, new product announcements, etc.

Use BW’s logistics services to ensure that your medical security supplies are safe and reach your destination in time. Stop using CIF & EXW to avoid customs risk and the high freight. Use BW’s quality control services to ensure your business reputation.

Imported COVID-19 test kit to Japan
Japan manages IVD supplies and medical devices in the same department. In-vitro diagnostic drugs fall into two categories in registration management:

Category 1: New testing items.

Category 2: Existing testing products, such products are divided into 2-A and 2-B parts. 2-A: More important items in health and health care.
(1) In vitro diagnostic supplies for infectious disease detection.
(2) In vitro diagnostic drugs for blood type judgment.
(3) In vitro diagnostic supplies for pathogen genetic testing.
(4) In vitro diagnostic supplies for human genetic testing.
(5) Existing test items, but in-vitro diagnostic supplies using new measurement principles.

In addition, the detection sensitivity index is not within the scope of nationally registered products, and in Vitor, diagnostic supplies with new clinical diagnostic significance are also included in the 2-A range. 2-B: Items other than the above varieties.

In Japan, diagnostic reagents are classified as pharmaceutical products, and the competent department is the Ministry of Health, Labour and Welfare, subject to the supervision of the Pharmaceutical Machinery Law, and the “production and sales license of pharmaceutical products (production license or similar production record certificate)” must be submitted during customs clearance at the entry Copy, and “copy of the approval (or certification or filing certificate) for the production and sales of pharmaceutical products”.

Imported Coronavirus Detection Reagent to South Korea
The Ministry of Food and Drug Safety (MFDS) of Korea announced the partial revision plan of the Korean Medical Devices Act (MDA) in late 2013. In the implementation regulations of the medical device part, the entry “reagent for in vitro diagnostic analysis devices (reagent “for in vitro diagnostic analysis device” was changed to “in vitro diagnostic product”.

This means that including reagents, as well as all supplies used for in vitro diagnostics will be uniformly treated as in vitro diagnostic products (IVDs) for management. Supplies other than reagents are also listed as in vitro diagnostic products, which means that these supplies will be classified as medical devices, subject to medical device regulations and standards. In-vitro diagnostic products currently listed as pharmaceuticals require new import and production approvals by the end of 2014.

Admitted to KGMP certification for medical device access to South Korea, medical devices are classified into categories Ⅰ to Ⅳ.

Class Ⅰ medical devices: The management of these products is relatively loose. Local and foreign companies in South Korea only need to register online at MFDS.

For Class Ⅱ ~ Ⅳ medical devices, they must pass the comprehensive review of the Korean medical device authority before they can enter the Korean market. All Class Ⅱ ~ Ⅳ medical device products exported to South Korea must have complete technical documents, including:

(1) According to ISO System certificate issued by 13485;

(2) Product specification;

(3) Product brochure;

(4) Product raw material testing report;

(5) Product packaging;

(6) Product validity document (shelf life verification report);

(7) Product performance test report;

(8) Clinical report (if applicable);

(9) Software information (if applicable);

(10) Electrical safety and electromagnetic compatibility test report (if applicable);

(11) Biocompatibility test report ( If applicable).

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

MFDS (Korea Food and Drug Administration) started on-site audits of foreign manufacturers in April 2012. Except for Class I medical devices, others require on-site audits.

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Applying for the MFDS audit is similar to the domestic registration system assessment application, and also needs to provide a series of materials. KGMP audit needs to provide more information, mainly including (1) company profile; (2) product registration certificate; (3) employee roster; (4) List of production products; (5) Product specification; (6) System certificate issued according to ISO 13485; (7) Equipment list; (8) Supplier information; (9) Quality manual; (10) Audit by other agencies Results; (11) Main product records. First, you need to submit the information to the Korean medical device quality management review agency for review. The review takes about 30 days.

The MFDS on-site audit standards for manufacturers are medical device production and quality management standards, which are very similar to ISO 13485. It can also be said that the on-site audit of KGMP is based on ISO 13485 audit. 30 days after submitting the MFDS information, the medical device quality management review agency will send 2 ~ 3 auditors to the company for an on-site audit, and the audit time is 3 ~ 5 days.

Imported Coronavirus Detection Reagent to Australia

It must be registered by Australia’s TGA and meets the standard code: AS / NZS 1716: 2012, which is the standard for respiratory protection devices in Australia and New Zealand. TGA is the abbreviation of Therapeutic Goods Administration. The full name is Therapeutic Goods Administration. It is the supervision agency of Australia’s therapeutic goods (including drugs, medical devices, genetic technology, and blood products).

Australia divides medical devices into Class I, Is and Im, IIa, IIb, and III. The product classification is almost the same as the EU classification. If the product has obtained the CE mark, the product category can be classified according to CE.

Australia adopts the methods of self-assessment of low-risk enterprises and approval of high-risk by the government. It implements different management of products listed in different catalogs, highlighting the key management of high-risk products. The Australian Register of Therapeutic Goods (ARTG) under the jurisdiction of TGA divides medical devices into three types of management: Registrable, Listable and exempt. Except for express exemptions, only products that have been approved after examination can be found in Sell ​​on the market.

For high-risk medical devices, their quality, safety, and effectiveness need to be evaluated by TGA and approved before marketing. Low-risk Class I devices do not have a mandatory quality system and clear requirements for pre-market evaluation but require manufacturers to provide relevant documents to prove its safety and effectiveness.

Use BW’s logistics services to ensure that your medical security supplies are safe and reach your destination in time. Stop using CIF & EXW to avoid customs risk and the high freight. Use BW’s quality control services to ensure your business reputation.

Import and ship COVID-19 test kit, medical masks, medical protective clothing, ventilator, infrared thermometer，protective gloves, goggles from China.

One-stop guide&unserstanding, update 2020, All you need to know!（All legal, with all types of supplier resources attached！）

High-risk devices, such as HIV and Hepatitis C in vitro diagnostic reagents, are “registered” devices. Before being approved to enter the Australian market, they need to comprehensively evaluate the quality, safety and effectiveness of the product. The system, number management. Generally, the review of registered products is completed within 3 months.

Most other devices belong to the category of “records”. After a brief evaluation to check whether they meet the production, labeling and quality standards, once they enter the Australian market after approval, they will enter the medical supplies registration system as catalog products and be numbered. The filing usually takes one month. Application for medical device registration is required. Sponsors (individuals or companies that are legally responsible for the sale of medical devices, usually distributors) are encouraged to use (Devices Electronic Application Lodgement System, DEAL).

If the product has been registered or filed, the manufacturer’s replacement of the distributor has no effect on it. After the approval of registration of foreign products, regular registration is required once a year to indicate whether the product model, performance and quality have changed. TGA is solely responsible for evaluating the conformity of medical devices and charges a certain fee. The relevant fee amount can be found on TGA’s website.

Note: The access certification for all countries, such as CE certification, must be a certification issued by a certification body designated by the importing country.

1 How to find  COVID-19 test kit supplier from China:
In order to reduce overseas buyers encountering illegal and non-compliant Chinese suppliers, and spending a lot of time unable to find legal suppliers, BW announced to global buyers free of charge that China National Food and Drug Administration has legal export licenses from 4.2. Supplier List:

Click here to download the suppliers ’list of the COVID-19 test kit from China, this is the fastest way to meet the real Chinese COVID-19 test kit supplier.

Using BW ’s logistics and inspection services will be the biggest support for BW. Let BW become your logistics supplier for Asian shipments, and you will get more surprises.

How to ship the COVID-19 test kit from China：

The colloidal gold kit can be stored at room temperature, air transportation is more convenient

Nucleic acid detection reagents need to be transported by a cold chain of minus 20 degrees. The requirements for the transported goods are particularly high, need check case by case and providing logistics solutions.

Regulatory category

National technical standards for testing reagent production

Guidelines for the approval of entry-exit quarantine for special items
Special articles refer to articles such as microorganisms, human tissues, biological products, blood and their products that enter and leave the country. Therefore, such items are easy to spread infectious diseases or have the potential risks of spreading infectious diseases, cold chain transportation and high requirements for customs clearance speed. They are the objects of strict quarantine supervision by the customs and are not allowed to enter or leave the country without quarantine permission.

Application materials
When applying for approval of special items, the consignor or his agent shall provide corresponding materials in accordance with the following provisions.

“Application Form for Sanitation and Quarantine of Entry / Exit Special Items”

Descriptive materials for entry-exit special items, including Chinese and English names, categories, ingredients, sources, use main sales channels, import and export countries or regions of special items, manufacturers, etc.

Imported biological products and human blood products for the prevention, diagnosis, and treatment of human diseases shall provide the Import Drug Registration Certificate issued by the Drug Supervision and Administration Department of the State Council

For entry or exit special articles that contain or may contain pathogenic microorganisms, the scientific name (Chinese and Latin) of the pathogenic microorganisms, explanatory documents of biological characteristics (Chinese and English control) and the corresponding biosafety of the production operator or user shall be provided Proof of prevention and control level

Biological products and human blood products that are used for the prevention, diagnosis and treatment of human diseases out of the country shall provide the sales certificate issued by the drug regulatory department

If the outbound special items involve the management of human genetic resources, the approval document issued by the human genetic resources management department shall be provided

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Units using entry-exit special items that contain or may contain pathogenic microorganisms shall provide qualification certificates for biosafety laboratories that are compatible with biosafety risk levels. Laboratories above BSL-3 level must be approved by a national accreditation body

For the entry or exit of highly pathogenic microbial bacteria (toxic) species or samples, the approval documents of the competent health department of the people’s government at or above the provincial level shall be provided

When applying for approval of special items for the first time, the following materials should also be provided

If the applicant is a unit, please provide
The basic situation of the unit, such as unit management system certification, unit address, production site, laboratory setting, storage facility equipment, product processing, production process or process flow, floor plan, etc.

Laboratory biosafety certification documents

If the applicant is a natural person, a copy of ID card should also be provided
Those who bring their own blood products or biological products for prevention or treatment of diseases only need to go through the health and quarantine examination and approval procedures, and they should show the relevant certificate of the hospital to the customs at the time of entry and exit; The course of treatment is limited.

Process flow
Flowchart of approval for entry-exit special articles for health and quarantine
The consignor or agent of the imported special articles shall apply for approval of the special articles to the customs directly under the destination before the delivery of the special articles.

The consignor or agent of the outgoing special articles shall apply for approval of the special articles to the customs directly under the place where the special articles are delivered.
The applicant submits an application to the customs directly under the destination/location through the customs entry and exit special items health and quarantine supervision system.
Address: http://tswp.customs.gov.cn

After receiving the application for examination and approval of special items submitted by the applicant, the customs directly under the Customs shall deal with it according to the following circumstances:

1
If the application items do not require the approval of special items according to law, the applicant will be informed immediately that it will not be accepted
2
If the application item does not fall within the scope of power of the unit according to law, it will immediately make a decision not to accept it, and inform the applicant to apply to the relevant administrative agency or other directly under the customs
3
If there are errors in the application materials that can be corrected on the spot, the applicant is allowed to correct them on the spot
4
If the application materials are incomplete or do not conform to the legal form, the applicant shall be notified on the spot or within 5 days from the date of receipt of the application materials for all the contents to be corrected. If you do not notify within the time limit, the application will be accepted as of the date you receive the application materials
5
The application items are within the scope of the unit ’s authority, the application materials are complete and conform to the legal form, or the applicant submits all the revised application materials according to the unit ’s requirements, the application for administrative license will be accepted

Use BW’s logistics services to ensure that your medical security supplies are safe and reach your destination in time. Stop using CIF & EXW to avoid customs risk and the high freight. Use BW’s quality control services to ensure your business reputation.

Review 

The customs directly undertaking the strict examination of the application materials in a timely manner and verifying the substance of the application materials by means of expert data review, on-site assessment, laboratory testing, etc. according to the situation.

Decision 

If the applicant’s application meets the statutory conditions and standards, issue the “Entry / Exit Special Items Sanitation and Quarantine Approval Form”; if the applicant’s application does not meet the statutory conditions and standards, make a written decision not to approve and explain the reasons and inform the applicant Enjoy the right to apply for administrative reconsideration or file an administrative lawsuit according to law.

Processing time

The direct customs shall make a decision on whether to grant permission within 20 working days from the date of accepting the application. If a decision cannot be made within 20 working days, it may be extended by 10 working days upon approval by the person in charge of this administrative organ.

Charges

No charge.

Advisory Channel

For details, please refer to the customs website directly under the location or call the customs “12360” hotline.

Clarification on the quality issues of coronavirus detection reagents shipped from China, and practical feedback on how to distinguish between colloidal gold detection and nucleic acid detection: updated on May 5, 2020

Current overseas consumers are easily confused when using it. The previous issue of the controversial coronavirus detection reagents in Spain is an example. Nucleic acid detection and antibodies (colloidal gold method) are always qualitative detections of new coronavirus.

Colloidal gold can detect the results by the naked eye, and the results can be obtained in 15 minutes. It is suitable for a large-scale census; nucleic acid detection is to be completed by laboratory equipment. It takes 2-8 hours to detect the results, which is most suitable for the diagnosis of individual cases.

The main reasons for the problems are:

The first detection period is inappropriate. The prerequisite for colloidal gold testing is that it requires antibodies to be produced after a viral infection in the patient. In the early stage, if the body does not produce immune antibodies, it is not applicable and the result cannot be detected. In contrast, nucleic acid detection, as the “gold standard” for the diagnosis of new coronavirus infection, is to directly detect the genetic material of the virus, as long as a certain amount of virus has accumulated in the collection site (can be detected, the sensitivity of each company’s product is different), It can be detected by the method of fluorescent PCR, without waiting for the body to produce immunity, and it is discovered earlier than the colloidal gold method.

The second is an improper sampling. False negatives can also occur in nucleic acid testing, mainly due to the fact that the doctor is not deep enough to collect the sample or the collection method is not correct, resulting in insufficient sample virus and unable to detect the result.

Therefore, we remind that the vast majority of Chinese coronavirus reagent export enterprises must clearly understand their products, and at the same time guide overseas importers to clarify their needs, understand the product specifications, standards, and uses and scope of application in the contract. It should be handled in accordance with commercial contracts, to avoid the other party to borrow problems.

Use BW’s logistics services to ensure that your medical security supplies are safe and reach your destination in time. Stop using CIF & EXW to avoid customs risk and the high freight. Use BW’s quality control services to ensure your business reputation.