On March 31 this year, the Ministry of Commerce, the General Administration of Customs, and the State Food and Drug Administration issued the Announcement on the Orderly Development of Export of Medical Materials (Joint Announcement No. 5 of 2020). Medical device product registration certificate.

 

On April 10, the General Administration of Customs issued Announcement No. 53 of 2020 and included the export infrared thermometer into the scope of medical supplies for the inspection of export commodities. Because the export of infrared thermometers has become very complicated, a large number of illegal customs declaration goods have been seized by Chinese customs, and they have remained at the airport until now.

 

Many products cannot be exported normally due to packaging problems and lack of qualification of suppliers.

 

Many importers simply treat infrared thermometers as a very ordinary product and do not fully understand the product’s understanding, research, and customs regulations, and import and ship infrared thermometers directly from China.

 

In order to let more overseas importers know how to ship infrared thermometers from China, Bestforworld summarized the most practical consultation and information.

 

What is the corresponding customs HS code of the infrared thermometer when shipping from China?

 

According to the requirements of the Annex of Announcement No. 53 of 2020 of the General Administration of Customs of China, the HS code corresponding to the infrared thermometer is 9025199010, and the corresponding product name is “Infrared Body Measuring Instrument”. Commonly known as “forehead gun”, it is a kind of medical equipment.

 

What is the principle structure of the infrared thermometer?

 

Any object above the absolute zero (-273 ℃) will emit infrared rays. The infrared thermometer uses an infrared temperature sensor to receive infrared rays, calculate and display temperature data.

 

When in use, align its probe with the center of the forehead, keeping the distance within 3cm, and lightly press the measurement key. After the body vibrates, the LCD screen displays the degree as the body temperature.

What documents do infrared thermometers need to provide for export?

 

Infrared thermometers are classified as Class II managed medical devices included in China’s “Catalogue of Medical Devices”. Therefore, in accordance with the requirements of “Joint Announcement No. 5 of 2020”, in addition to various trade documents, the “Chinese People” “Republic Medical Device Registration Certificate” and “Export of Medical Materials”.

 

Like other medical supplies for export as stipulated in the General Administration of Customs Announcement No. 53 of 2020, infrared thermometers do not need to apply for an electronic fund account before export, and they can directly declare to the customs for export, and the port customs will carry out inspections instead of origin.

 

At the time of export, the Customs, in accordance with Article 6 of the Commodity Inspection Law, “Importable import and export commodity inspections refer to conformity assessment activities to determine whether the import and export commodities listed in the catalog comply with the mandatory requirements of the national technical regulations. : Sampling, inspection, and inspection; evaluation, verification, and conformity assurance; registration, approval, and approval, and a combination of items “, and Article 44 of the” Regulations for the Supervision and Administration of Medical Devices “Enterprises exporting medical devices should guarantee their export Medical devices comply with the requirements of the importing country (region) “, and in accordance with the requirements of the distribution control directive, implement on-site conformity assessment for the following items:

 

(1) Verify whether the goods belong to medical devices and whether there are false reports of non-medical devices.

(2) Whether the physical information of the goods belonging to medical devices is consistent with the medical device registration certificate. Among them, the content of the label of the smallest physical sales unit (body or packaging) should be consistent with the registered content (see the figure below for details).

(3) The packaging, identification, product name, quantity of the goods, and whether there is contamination, mildew, pollution, expiration date, damage, etc.

(4) Evaluate the quality and safety commitment (conformity guarantee) or test report submitted by the enterprise.

(5) Sampling and sending to the laboratory to test the intrinsic quality of commodities.

(6) Inspection and testing of other items that require inspection.


 

What is the basis for judging that infrared thermometer belongs to the category II management medical device?

The “Medical Device Classification Catalog” describes the infrared thermometer as “usually composed of an infrared temperature sensor, a probe cover, a display unit, a power supply circuit, and a measurement circuit. The infrared temperature method is used to measure the temperature display or data output”, and the expected use is ” Infrared method is used to measure the clinical temperature of the patient, which is usually used to measure the temperature of the ear canal and forehead of the patient. ” To meet the above description and intended use, the export declaration must provide the “People’s Republic of China Medical Device Registration Certificate” and “Export Medical Material Declaration”.

 

In addition, Bestforworld reminds buyers of infrared thermometers imported from China that medical far-infrared thermal imagers also belong to the scope of “infrared thermometers”. When applying for export, the above two materials must be provided.

 

Which products are easily confused with infrared thermometers?

 

This problem is very classic. According to what Bestforworld knows, the working principles of veterinary thermometers and industrial thermometers are similar to infrared thermometers, but they are not medical devices. It is not necessary to provide the “PRC Medical Device Registration Certificate” when applying for export. The main differences between the three are as follows:

 

1A typical infrared thermometer has a working ambient temperature of 16 ° C to 35 ° C, a measurement range of 35 ° C to 42 ° C, the measurement accuracy of ± 0.2 ° C, and a measurement accuracy outside the measurement range of ± 0.3 ° C. This requirement is set in accordance with Article 4.4 of China’s recommended standard “Medical Infrared Thermometer” Part 1: Ear Cavity “(GB / T 21417.1-2008).

 

2Typical veterinary temperature measuring gun, the working environment temperature is 0 ℃ to 50 ℃, the measurement range is 35 ℃ to 43 ℃, the measurement accuracy is ± 0.4 ℃.

 

3Typical industrial temperature measuring gun, the working environment temperature is 0 ℃ to 50 ℃, the measurement range is from minus -35 ℃ to 850 ℃, and the measurement accuracy is ± 1 ℃ or other according to different environments.


 

How to test infrared thermometers exported to countries between government agreements?

 

According to the bilateral agreement signed between the Chinese and foreign governments, exporting infrared thermometers to Sierra Leone, Ethiopia, Iran, and Yemen requires an application for pre-shipment inspection, including origin inspection and port supervision and inspection, and a pre-shipment inspection certificate is issued by customs.

 

Sierra Leone

Each batch of trade commodities worth more than the US $ 2000

 

Ethiopia

Each batch of trade commodities worth more than the US $ 2000

 

Iran

The products listed in Chapters 25 to 29 and Chapters 31 to 97 of the “Catalogue of Entry and Exit Products for Inspection and Quarantine by Entry-Exit Inspection and Quarantine Institutions” with customs supervision conditions of B and inspection and quarantine category of N.

Yemen

Products in Chapters 25 to 29 and Chapters 31 to 97 of the International Convention on the Harmonized Commodity Description and Coding System (HS Code).

 

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!

 

How to deal with violations of laws and regulations found in the declaration of export of infrared thermometers?

This is also a concern of importers. Bestforworld’s customs declaration department reminds us that if one or more of the following acts are found, the customs will be punished or dealt with in accordance with the “Customs Law”, “Commodity Inspection Law” and its implementation regulations. Constitute a crime, be held criminally responsible.

 

(1) Falsely reporting medical materials as non-medical materials.

(2) Evasion of commodity inspections by concealing customs declarations, hiding, etc., and the occurrence of mildew, pollution, expiration of shelf life, damage, etc. of medical material capital.

(3) The medical materials are pretended to be true, sub-good, or unqualified medical materials pretending to be qualified medical materials.

(4) When applying for the export of medical materials, the medical device registration certificate is found to be forged, altered, traded, or misappropriated after the examination.

(5) The name, quantity, specification, price, etc. of the declared medical export materials should not be declared or the declaration is not true.

(6) If the party concerned exports medical materials, the product is unqualified due to the content of the product’s internal and external packaging, product specifications, etc.


According to the requirements of “Joint Announcement No. 5 of 2020”, in addition to obtaining the “People’s Republic of China Medical Device Registration Certificate”, the export infrared thermometer must also meet the quality standards of the importing country (region). What are the specifics?


 

At present, according to the situation at Bestforworld, the product quality standards and entry requirements for exporting infrared thermometers to different countries and regions are as follows:

 

Ship infrared thermometer to the United States:

 

Medical devices entering the US market can be applied for under three conditions: exemption, 510 (k), and PMA. Common infrared thermometers are classified as Class II medical devices in the US FDA and need to be applied in accordance with 510 (k). The 510 (k) application process:

  1. Conduct product testing (performance testing, biological testing)
  2. Prepare 510 (k) technical documents and submit to FDA for review
  3. Obtain 510 (k) approval letter from FDA
  4. Complete factory registration and device listing

 

The 510 (k) document is a pre-market application document submitted by the enterprise to the FDA. The purpose is to prove that the product applied for listing and the product that has been legally sold in the US market are substantially equal in safety and effectiveness, that is Equivalent equipment. Applicants must compare the device applying for marketing with one or more similar devices currently on the US market and draw conclusions that support equivalent devices. The FDA has a basic requirement for the information that must be included in the FDA 510 (k) registration document, and its content is rough as follows:

 

  1. Application letter. This part should include the basic information of the applicant (or contact person) and the company, the purpose of FDA 510 (k) submission, the name and model of the device to be marketed, and the classification information, the product name and 510 (k) for a substantial equivalent comparison number.
  2. Directory. That is a list of all information (including attachments) contained in the FDA 510 (k) document.
  3. Authenticity guarantee statement. FDA has a standard sample.
  4. Name of equipment. Namely the product common name, FDA classification name, product trade name.
  5. Register the number. If the company has already registered the company when submitting the FDA 510 (k), it should provide the registration information, if not registered, it should also be noted.
  6. Classification. That is, the classification group, category, management number, and product code of the product.
  7. Performance standards. The mandatory or voluntary standards that the product meets.
  8. Product identification. Including enterprise packaging logo, instruction manual, packaging accessories, product labeling, etc.
  9. Substantial equality comparison (SE). Choosing the right product for comparison is a key step in the 510 (k) application. When comparing, the following aspects should be considered: The enterprise must provide sufficient information to prove that the device applied for marketing and the device being compared are substantially equal (SE), otherwise, the 510 (k) application will not pass.

     10.510 (k) summary or statement. Summary of application documents and conclusions supporting equivalent devices.

  1. Product description. Including the intended use of the product, working principle, power source, components, photos, process drawings, assembly drawings, structural schematics, etc.
  2. Product safety and effectiveness. Including various design and test materials.
  3. Biocompatibility. Biocompatibility refers to a concept of various biological, physical, chemical, and other reactions produced after the interaction between materials and organisms. Generally speaking, it is the degree of compatibility of the material with the human body after implantation, that is to say, whether it will cause toxic effects on human tissue.
  4. Pigment additives (if applicable).
  5. Software verification (if applicable).
  6. Sterilization (if applicable). Including description of sterilization methods, sterilization verification product packaging and labeling, etc.

 

The relevant testing standards for infrared thermometers in the United States include:

ANSI / AAMI ES60601-1: 2005 / (R) 2012, (IEC 60601-1: 2005, MOD) “Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance”, ANSI / AAMI / IEC 60601-1 -2: 2014 “Medical Electrical Equipment Part 1-2: General Requirements for Safety, Parallel Standard: Electromagnetic Compatibility Requirements and Tests”, ANSI / AAMI HA 60601-1-11: 2015 (IEC 60601-1-11: 2015, MOD) “Medical Electrical Equipment Part 1-11: General Requirements for Basic Safety and Basic Performance. Parallel Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in Home Healthcare Environments”, ASTM E 1965-98: 2016 “Intermittent Determination Infrared thermometer for patient temperature. According to the detection type, it is divided into basic requirements, electromagnetic compatibility requirements, and performance requirements.

 

A brief analysis of technical standards:

The items involved in the US infrared thermometer include input power; protective grounding, functional grounding, and potential equalization; dielectric strength; drop resistance; electromagnetic compatibility, etc.

 

 

Ship infrared thermometer to EU:

The European Union divides medical devices into three major categories, Class I (including I and I *), Class II (including IIa and IIb), and Class III. No matter which category it belongs to, exporting to the EU requires CE certification.

 

Infrared thermometers belong to Class II medical devices. Products of Class II and above require the participation of the EU Notified Body, such as TUV South Germany, TUV Rheinland, BSI, DNV, SGS, etc. Enterprises need to complete the CE certification documents and submit the system audit after passing the audit, and finally get the CE and the system certificate that conforms to the EU standards.

 

The CE certification of infrared thermometers needs to meet the EU Medical Device Directive 93/42 / EEC (MDD) or the EU Medical Device Regulations EU2017 / 745 (MDR).

 

The CE certification procedures for infrared thermometers are as follows:

  1. The enterprise submits the certification application to the certification body and fills in the certification inquiry sheet to the certification body.
  2. The certification body submits a quotation to the company applying for certification, and the contract is completed after the company signs and confirms.
  3. The enterprise submits the ISO9000 + ISO13485 quality system documents, that is, quality manuals and procedure documents, to the certification body for the certification body to review the system documents; before the quality system audit, the enterprise should have at least three months of quality system operation records and complete 1-2 The internal quality system audit.
  4. The certification body issues a certification product test notice to a laboratory recognized by the certification body, and the laboratory will test the product for certification. After passing the test, the laboratory issues a test report. The relevant testing standards are as follows:

EN 60601-1: 2006 + A1: 2013 “Medical electrical equipment Part 1: General requirements for basic safety and basic performance”

EN 60601-1-2: 2015 “Medical electrical equipment Part 1-2: General requirements for safety Parallel standards: Electromagnetic compatibility requirements and tests”

EN 60601-1-11: 2015 “Medical electrical equipment Part 1-11: General requirements for basic safety and basic performance Parallel standards: Requirements for medical electrical equipment and medical electrical systems used in home healthcare environments”

ISO80601-2-56: 2017 “Medical electrical equipment Part 2-56: Particular requirements for basic safety and basic performance of clinical thermometers for body temperature measurement”

  1. The manufacturer must establish the technical document (TCF) of the product according to the requirements of the product and the requirements of the risk assessment. If required by the relevant authorized department, the manufacturer must submit the technical documentation and EC declaration of conformity together for inspection.
  2. The certification body audits the company’s ISO9000 + ISO13485 quality system and TCF files.
  3. After the formal audit is passed, the certification body will sign a framework agreement with the company to clarify the principles that all parties should follow and the scope of the CE mark.

 

It is recommended that companies find a notified body recognized by the EU for testing:

  1. The official website of the European Union MDD 93/42 / EEC Medical Devices Directive:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=13

  1. The official website of the European Union’s official website MDR (EU) 2017/745 medical device regulations for inquiries:

https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34

 

A brief analysis of technical standards:

The basic requirements of the EU and US standards are adopted from the international standard IEC 60601-1: 2005 (the EU standards are adopted from IEC 60601-1: 2005 + A1: 2012), IEC 60601-1-11: 2015; both electromagnetic compatibility requirements are adopted The standard is from the international standard IEC 60601-1-2: 2014. Therefore, there is no big difference between the basic requirements and the electromagnetic compatibility requirements. For details, please refer to the analysis of the previous US technical standards, but the EU performance standards are different from the US.

Ship infrared thermometer to Japan

If the product needs to be put on the market, it must meet the Japanese Pharmaceutical and Medical Device Act (PMD Act). Under the requirements of the PMD Act, the TOROKU registration system requires foreign manufacturers to register and manufacture with the Japanese Pharmaceutical and Medical Device Comprehensive Agency (PMDA)商 信息。 Business information.

 

The website of the Japanese comprehensive agency for pharmaceuticals and medical devices: www.pmda.go.jp (requires copying and opening through a browser).

 

Ship infrared thermometer to South Korea

The Ministry of Health and Welfare (Ministry of Health and Welfare), referred to as the Ministry of Health MHW, is mainly responsible for the management of food, drugs, cosmetics and medical devices. It is the most important health care department. According to the “Medical Devices Act”, the Ministry of Food and Drug Safety under the Ministry of Health and Welfare is responsible for the supervision of medical devices. The KFDA registration process is:

 

  1. Determine the product classification (I, II, III, IV) and select KLH (Korea Licensee).
  2. Class II products need to apply for KGMP certificates and accept on-site audits. Class II products are generally authorized third-party auditors and obtain KGMP certificates.
  3. Class II products need to send samples to Korean MFDS authorized laboratories for Korean standard testing.
  4. Submit technical documents (test report, KGMP certificate, etc.) from KLH to MFDS (Ministry of Food and Drug Safety of Korea) for registration approval.
  5. Pay the application fee.
  6. Rectification of registration documents and registration approval.
  7. Designate Korean agents and distributors to sell products. The standards involved are:

KS C ISO 80601-2-56: 2012 “Medical electrical equipment Part 2-56: Particular requirements for basic safety and basic performance of clinical thermometers for temperature measurement”

KS C IEC 60601-1: 2011 “Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance”

KS C IEC 60601-1-2: 2012 “Medical Electrical Equipment Part 1-2: General Requirements for Safety Parallel Standard: Electromagnetic Compatibility Requirements and Tests”

KS C IEC 60601-1-11: 2012 “Medical electrical equipment. Part 1-11: General requirements for basic safety and basic performance. Parallel standard: Requirements for medical electrical equipment and medical electrical systems used in home healthcare environments”

KS ISO 10993-5: 1999 “Medical Device Biological Evaluation-Part 5: In Vitro Cytotoxicity Test”

KS ISO10993-10: 2002 “Medical Device Biological Evaluation-Part 10: Irritation and Delayed Allergic Response Test”

 

Korea Pharmaceutical Traders Association website: www.kpta.or.kr (requires copying and opening via browser).

 

Ship infrared thermometer to Australia

In Australia, medical devices refer to instruments, equipment, utensils, materials or other items used on the human body (used alone or in combination and software required for proper application) for diagnosis, prevention, monitoring, treatment or alleviation of diseases .

 

The production of medical device products in Australia must pass a conformity assessment to assess whether the medical device meets the standard requirements for listing in the relevant national market (such as Australia, Europe and the United States); the sale of medical devices must be carried out in the device electronic application declaration system (DEAL) Apply online to complete product registration at the Australian Therapeutic Goods Registry (ARTG). ARTG is a registration system for therapeutic products in the registry, which requires distributors to be responsible for the medical device products produced and operated (including import and export).

 

To produce and operate medical device products in Australia, local manufacturers need to obtain a conformity assessment certificate issued by the Therapeutic Goods Administration; overseas manufacturers need to have a mutual recognition agreement certificate / European CE certification and Australia’s declaration of conformity. The manufacturer submits the appropriate conformity assessment certificate to the distributor, and the distributor submits it through the DEAL system as a certificate of the manufacturer’s qualification. After the TGA review, the manufacturer will apply for the qualification certificate. Distributors submit medical device applications through the DEAL system and pay a certain application fee. TGA will add the medical device to the ARTG record. Distributors must pay an annual fee, and TGA needs to monitor the products after they are placed on the market.

 

Overseas manufacturers need to have mutual recognition agreement certificate / Europe CE certification and Australia’s declaration of conformity.