Since the epidemic, global trade has pressed the “pause button”, and only epidemic prevention materials are hot, especially. But since the implementation of the new policy on the 10th, the export of anti-epidemic materials is likely to be hindered, and export supervision has become stricter! In particular, some small-scale manufacturers and freight forwarders and foreign trade enterprises that have no record qualification. Let’s first look at the General Administration of Customs Announcement No. 53.
The General Administration of Customs issued Announcement No. 53, stating that from yesterday (April 10, 2020), 11 “medical materials” commodity coding projects will implement import and export commodity quality inspections. Gloves, infrared body thermometers, surgical gloves, patient monitors, cotton pads, gauze, bandages, and medical disinfectants are all listed, that is, almost all medical supplies are included.
The legal inspection is the goods with the supervision condition of A (import) or B (export) on the customs declaration form. During customs declaration, the customs clearance form of the inspection bureau must be provided, that is, the legal inspection goods. The goods subject to statutory inspection include: other import and export commodities subject to inspection within the legal inspection catalogue and as required by laws and administrative regulations.
According to relevant laws and regulations, the consignor or its agent of the export commodities that must be inspected by the commodity inspection agency shall report to the commodity inspection agency for inspection within the place and time limit specified by the commodity inspection agency. The commodity inspection agency shall complete the inspection within the time limit uniformly prescribed by the national commodity inspection department and issue an inspection verification certificate. Exported goods that are legally inspected are not allowed to be exported if they are not inspected or fail to pass the inspection.
The “People’s Republic of China Import and Export Commodity Inspection Law” stipulates that violations of regulations will require import commodities inspected by the commodity inspection agency to be sold or used without inspection, or export commodities that must be inspected by the commodity inspection agency without inspection. For export, the commodity inspection agency shall confiscate the illegal gains and impose a fine of more than 5% to less than 20% of the value of the goods; if it constitutes a crime, criminal responsibility shall be investigated according to law.
The customs changed the supervision conditions, indicating that the quality of exported medical supplies will be strictly controlled. In response to this news, some merchants said: “Temporary changes in supervision in a hurry and immediate implementation will make people have no buffer”, and hope that the customs can implement a compromise program, at least to announce the transition in advance.
Anti-epidemic materials export business is not calm
After discovering that the anti-epidemic materials export laws were checked, many businesses and some netizens were not calm, and this news spread wildly in the industry.
After learning of this news, some netizens began to complain, saying that this approach is “one size fits all”, saying that the correct way to supervise is to add tax numbers like epidemic prevention materials, which will hurt the innocent and enterprises will be difficult. It’s worse now!
The opposite is that the majority of people with this idea are exporters and even some non-product sellers. The quality problem of the export of epidemic prevention materials is the root cause of legal inspection. The country’s face must be lost by poor quality epidemic prevention materials.
Regarding this policy, in fact, the legal inspection does not mean that you will not give up, and exporters of anti-epidemic materials may not be cool! For enterprises, it is also a process of survival of the fittest, and kicking out some unqualified anti-epidemic materials merchants will not reduce the credibility of domestic products. At this time, the legal inspection is to play a filtering role. China is not just a factory in the world, there should be more high-quality products, and quality is the future.
As for the quality control of the export of anti-epidemic materials, the country has also been taking action.
The Customs investigates and deals with a large number of unqualified exports of anti-epidemic materials, and must deal with them seriously
According to the news released by the Customs today, on March 31, the Ministry of Commerce, the General Administration of Customs, and the State Drug Administration jointly issued the “Announcement on the Orderly Development of Export of Medical Materials”, requiring export of testing reagents, medical protective clothing, breathing The 5 types of products such as mobile phones and infrared thermometers must obtain the relevant qualifications of the national drug regulatory authority and meet the quality standards of the importing country (region).
For the medical materials listed in the “Announcement”, a 100% document review is carried out, focusing on checking whether the name and quantity of the product are consistent with the declaration, whether the appearance is mildew, whether there is pollution/pollution, whether it exceeds the shelf life, whether it is damaged and infringed, and whether it is There are situations of entrapment and entrainment, adulteration, adulteration with fake, sub-good, and unqualified products as qualified products. Since the announcement, the Customs has seized 11.205 million medical materials produced by non-listed companies or without medical device product registration certificates in trade, mail, express mail, cross-border e-commerce and other channels, of which 99.41 million are kouzhao and 155,000 protective clothing There are 1.085 million test reagents and 24,000 infrared thermometers.
As we all know, because of the epidemic, there are not many newly established kouzhao factories this year, and most of the manufacturers have not had time to apply for qualifications, and there are also a few of them that are second-to-good in order to make money quickly. If there are too many non-medical reports, non-medicine will go out of the brain, and quality problems will only make the reputation of the goods made in China worse, affect the national reputation, and are not conducive to the development of foreign trade.
The inspection is also to ensure the quality of the exported anti-epidemic materials. Survival of the fittest is also the survival rule of the market. Sellers with complete qualifications and excellent quality may not be cool. Multiple inspections have little effect, and the restriction of Sanwu products is a good opportunity to expand market share. As for those who are not qualified, and want to make quick money with defective products,
In response to the export legal inspection, Shandong Drick Testing Instruments has kept the quality in check
At present, the main test standards for domestic production are: GB 2626-2019 respiratory protection self-priming filter anti-particulate respirator; GB/T 32610-2016 daily protection type; GB 19083-2010 medical protection technical requirements; YY 0469-2011 medical surgery ; YY/T 0969-2013 One-time use medical.
1. “GB 19083-2010″ testing instrument
Tensile testing machine: This standard stipulates that the breaking strength should not be less than 10N. To test this item, you can use a tensile testing machine and configure a professional test fixture to test the tensile strength and tensile breaking force.
Particulate Filtration Efficiency (PFE) Tester: To test the protective effect of particulate matter, a cold generation aerosol generator is used to generate continuous and stable aerosol particles, and a high-precision PM2.5 sensor measures the aerosol concentration. The whole particle anti-leakage design, the instrument includes: sex particle aerosol generator, oily particle aerosol generator, aerosol particle static charge neutralization device, temperature and humidity sensor, laser dust particle counter, breathing simulator, protective effect aerosol concentration Detection device, protective effect suction gas sampling tube and other parts.
Respiratory resistance tester: It is used to measure the inhalation and exhalation resistance under the specified conditions. It is suitable for manufacturers and national labor protection products inspection agencies to carry out relevant tests and inspections on products. The GB 19083-2010 standard stipulates that under a gas flow rate of 85 L/min, the suction resistance must not exceed 343.2 Pa (35 mm H2O).
Synthetic blood penetration tester: spray a certain amount of synthetic blood at a certain pressure and distance in the horizontal direction toward the measured side, and observe the penetration of synthetic blood on the other side.
Surface moisture resistance tester (moisture meter): Install the sample on the sample holder at an angle of 45° to the horizontal, the sample center is located at the specified distance below the nozzle, use a specified volume of distilled or deionized water Spray the sample. By comparing the appearance of the sample with the evaluation standard and the picture, the water-wetting grade is determined, which is suitable for the water-wetting test to determine the moisture resistance of various fabric surfaces with or without water resistance and water-repellent finishing.
Detection of microbial indicators: total bacterial colony CFU/g: ≤100; coliform bacteria: not detectable; Pseudomonas aeruginosa: not detectable; Staphylococcus aureus: not detectable; hemolytic streptococcus: not detectable; fungus: Not detectable. Need to establish a sterile laboratory (generally 30 to 50 square meters) and related equipment and utensils for microbiological testing
Ethylene oxide residue detection chromatograph: after medical ethylene oxide sterilization, it should be analyzed and sterilized after 7 to 15 days. After headspace gas chromatograph, its ethylene oxide residual amount should not exceed 10ug/g. It can only be released before leaving the factory.
Flame retardant performance tester: mainly used to test the combustion performance of the product after contacting the flame at a certain line speed, it is a special test instrument for flame retardant performance.
Adhesion tester: can quantitatively check the tightness of all types of respirators – gas masks, SCBAs, respirators, including N95. The adhesion tester eliminates the need for guesswork and tedious and error-prone qualitative adhesion test methods.
2. “YY 0469-2011″ testing equipment
Tensile testing machine: This standard stipulates that the breaking strength should not be less than 10N. To test this item, you can use a tensile testing machine and configure a professional test fixture to test the tensile strength and tensile breaking force.
Synthetic blood penetration tester: spray a certain amount of synthetic blood at a certain pressure and distance in the horizontal direction toward the measured side, and observe the penetration of synthetic blood on the other side.
Particulate Filtration Efficiency (PFE) Tester: To test the protective effect of particulate matter, a cold generation aerosol generator is used to generate continuous and stable aerosol particles, and a high-precision PM2.5 sensor measures the aerosol concentration. The whole particle anti-leakage design, the instrument includes: sex particle aerosol generator, oily particle aerosol generator, aerosol particle static charge neutralization device, temperature and humidity sensor, laser dust particle counter, breathing simulator, protective effect aerosol concentration Detection device, protective effect suction gas sampling tube and other parts.
Bacterial Filtration Efficiency (BFE) Tester: The main performance indicators not only meet the requirements of the B.1.1.1 test instrument of Appendix B Bacterial Filtration Efficiency (BFE) Test Method in YY0469-2011, but also comply with the American Society for Testing Materials ASTMF2100, ASTMF2101 The requirements stipulated in the European EN14683 standard, and on this basis, innovative improvements have been made. The simultaneous sampling method of dual gas channels is used to improve the accuracy of sampling. It is suitable for measurement verification departments, scientific research institutes, production enterprises and other related departments. Performance test of bacterial filtration efficiency.
Gas exchange pressure difference detector: It is based on the test principle of standard YY0469-2011. It uses a differential pressure sensor to realize the test of the pressure difference between the internal pressure and the external pressure. It is equipped with a special tooling device to achieve the test of the product. , It is mainly used for the measurement of gas exchange pressure difference, and can also be used to measure the gas exchange pressure difference of other textile materials.
Flame retardant performance tester: It is mainly used for the combustion performance after contacting the flame at a certain line speed. It is a special test instrument for flame retardant performance.
Detection of microbial indicators: total bacterial colony CFU/g: ≤100; coliform bacteria: not detectable; Pseudomonas aeruginosa: not detectable; Staphylococcus aureus: not detectable; hemolytic streptococcus: not detectable; fungus: Not detectable. Need to establish a sterile laboratory (generally 30 to 50 square meters) and related equipment and utensils for microbiological testing
Ethylene oxide residue detection chromatograph: after ethylene oxide sterilization, it should be analyzed and sterilized after 7 to 15 days. After headspace gas chromatograph, its ethylene oxide residual amount should not exceed 10ug/g within the national regulations It can be released before leaving the factory.
3. YY/T 0969-2013 One-time use medical testing instruments
Tensile testing machine: The breaking strength should not be less than 10N. To test this project, you can use a tensile testing machine and configure a professional test fixture to test the tensile strength and tensile breaking force.
Bacterial Filtration Efficiency (BFE) Tester: The main performance indicators not only meet the requirements of the B.1.1.1 test instrument of Appendix B Bacterial Filtration Efficiency (BFE) Test Method in YY0469-2011, but also comply with the American Society for Testing Materials ASTMF2100, ASTMF2101, the requirements of the European EN14683 standard, and on this basis, innovative improvements have been made. The dual gas path simultaneous sampling method is used to improve the accuracy of sampling. It is suitable for metrological verification departments, scientific research institutes, production enterprises and other Relevant departments’ performance tests on bacterial filtration efficiency.
Gas exchange pressure difference detector: The test principle of the ventilation resistance is to use the differential pressure sensor to realize the detection of the pressure difference between the internal pressure and the external pressure. It is equipped with a special tooling device to achieve the test sealing of the product, which is mainly suitable for The measurement of gas exchange pressure difference can also be used to measure the gas exchange pressure difference of other textile materials.
Detection of microbial indicators: total bacterial colony CFU/g: ≤100; coliform bacteria: not detectable; Pseudomonas aeruginosa: not detectable; Staphylococcus aureus: not detectable; hemolytic streptococcus: not detectable; fungus: Not detectable. Need to establish a sterile laboratory (generally 30-50 square) and related equipment and utensils for microbiological testing.
Ethylene oxide residue detection chromatograph: “YY/T 0969-2013″ standard mentions that after ethylene oxide sterilization, it needs to be analyzed and sterilized after 7 to 15 days, and its epoxy resin is tested by headspace gas chromatography The ethane residue should not exceed 10ug/g within the national regulations before it can be released for delivery. The detection of the residual amount of ethylene oxide is generally detected by gas chromatography, and the detection of the residual amount of ethylene oxide can be completed by using a headspace gas chromatograph.
YY 0469-2011
Specific test items Corresponding testing equipment
4.4 Breaking strength of connection point DRK101 comprehensive tensile testing machine
4.5 Synthetic blood penetration DRK227 synthetic blood penetration detector
4.6.1 Bacterial over-rate efficiency (BFE) DRK1000 bacterial over-rate efficiency tester
4.6.2 Particle over-rate efficiency (PFE) DRK506 particle over-rate efficiency tester
4.7 Pressure difference DRK260 respiratory resistance tester
4.8 Flame retardant performance DRK-07B flame retardant performance tester
4.10 Residue of ethylene oxide
YY/T 0969-2013
Specific test items Corresponding testing equipment
4.4 Breaking strength of connection point DRK101 comprehensive tensile testing machine
4.5 Bacterial over-rate efficiency (BFE) (YY 0469) DRK1000 bacterial over-rate efficiency tester
4.6 Ventilation resistance DRK709 pressure difference tester
4.8 Residue of ethylene oxide DRK GC1690 gas phase + headspace
GB 19083-2010
Specific test items Corresponding testing equipment
4.3 Breaking strength of the joint DRK101 comprehensive tensile testing machine
4.4 Filtration efficiency (over-efficiency of non-oily particles) DRK506 particle over-rate efficiency tester
4.5 Airflow resistance DRK260 respiratory resistance tester
4.6-Synthetic blood penetration DRK227 synthetic blood penetration detector
4.7 Surface moisture resistance DRK308A type fabric surface water wetting tester
4.9 Residue of ethylene oxide
4.10 Flame retardant performance DRK-07B flame retardant performance tester
4.12 adhesion
5.3.2 Temperature pretreatment, DRK250 constant temperature and humidity test chamber
GB/T 32610-2016
Specific test items Corresponding testing equipment
5.3 Color fastness to rubbing (dry/wet)/level DRK128C rubbing color fastness testing machine
5.3 Formaldehyde content Textile Formaldehyde Tester
5.3 PH value PH meter
5.3 Residue of ethylene oxide
5.3 Expiratory resistance, inspiratory resistance DRK260 respiratory resistance tester
5.3 Breaking strength DRK101 comprehensive tensile testing machine
5.3 Exhalation valve cover fastness
5.4 Filtration efficiency (ability to filter out particulate matter) DRK506 particle over-rate efficiency tester
5.5 Protection effect (ability to block particles)
Appendix A, 3 samples and pretreatment (high temperature, low temperature, damp heat)
DRK250 constant temperature and humidity test chamber
GB 2626-2006 Respiratory protective equipment Self-priming filter type anti-particulate respirator
Specific test items Corresponding testing equipment
5.3 Filtration efficiency N-type particles, P-type oil particles DRK506 particle over-rate efficiency tester
5.4 Leakage
5.5 Respiration resistance DRK260 respiratory resistance tester
5.6.1 Air tightness of exhalation valve DRK134 breathing valve air tightness tester
5.6.2 Axial tension of the exhalation valve cover DRK101 comprehensive tensile testing machine
5.7 Dead space Dead space test instrument
5.8 Vision DRK262 visual field measuring instrument
5.9 The headband should bear the pulling force DRK101 comprehensive tensile testing machine
5.10 Connection and connecting parts withstand axial tension
5.12 Airtightness DRK134 breathing valve air tightness tester
5.13 Flammability DRK-07B flame retardant performance tester
6.2 Temperature and humidity pretreatment DRK250 constant temperature and humidity test chamber
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Post time: Jun-16-2020