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Medica 2023 Germany -Welcome to our booth 6K55
2023 / 10 / 25
Medica 2023 Germany -Welcome to our booth 6K55
2023 / 10 / 20
Welcome to our booth 6K55 in Germany.
Welcome to Lanhine booth E7 H11-12 East China Import and Export Fair
2023 / 07 / 07
Zhejiang lanhine medical products ltd will attend the East China Import and Export Fair. Welcome to our booth. E7 H11-H12
12-15th July 2023 East China Import and Export Fair
2023 / 06 / 26
Zhejiang lanhine medical products ltd will attend the East China Import and Export Fair. Welcome to our booth. E7 H11-H12
2023 / 06 / 16
No.1 The Philippines meets RWLIANCE ROUTED MOUXIE Category B and C medical devices On September 27, 2022, the Philippine Food and Drug Administration issued Circular No. 2022-008 announcing that Class B, C, and D medical devices approved by members of the Association of Southeast Asian Nations will be eligible for Reliance Route registration, thus expediting review and accelerating market access. Asean members include Singapore, Thailand, Vietnam, Indonesia, Brunei, Cambodia, Laos, Malaysia, Myanmar and the Philippines. As stated in AO 2018-0002, these products are currently required to be approved by the manufacturer of the medical device Registration certificate for use in the ASEAN reference countries using the Common Submission Document (CSDT). In addition, the manufacturer must prove that the device itself is consistent with the documents previously submitted, otherwise it will not be eligible for registration with the Philippine Food and Drug Administration. The extension of all equipment review processes will allow thirty business days after receipt of proof of payment from the Center for Equipment Regulation and Radiological Health and Research (CDRRHR). This significantly reduces the previous review time of one hundred and eighty (180) business days or more. No.2 How to use RELIANCE ROUTE
2023 / 06 / 02
Vietnam's medical industry is growing rapidly along with the country's booming economy, and the country of nearly 100 million people is set to upgrade its medical infrastructure over the next decade. For now, Vietnam still relies on imported medical devices, so foreign manufacturers can expect strong growth in the next few years. Statistics show that 90% of medical device spending in Vietnam is now from foreign manufacturers. This provides manufacturers with an opportunity for rapid growth. 1. Competent institutions and core regulations Registration of medical device products in Vietnam is supervised by the Department of Medical Equipment and Construction (DMEC) under the Ministry of Health (MOH). At present, Vietnam's medical device registration regulations are in a transitional state. The new rules governing the registration of medical devices were issued on 8 November 2021, Decree No. 98/2021, replacing the previous Decree No. 36/2016/ND-CP, which was amended by Decree No. 169/2018/ND-CP and Decree No. 03/2020/ND-CP. The new rules will come into force on January 1, 2022, with a one-year transition period for Category C and D products. 2, product classification In Viet Nam, medical instruments are any tools, chemicals, equipment, materials and software necessary to detect, prevent, diagnose and/or mitigate disease, or to replace, examine, modify or provide surgical support during examination or treatment, used individually or in combination. Under the new rules, software is considered a medical device, but not regulated. Medical devices are classified in Vietnam according to their intended
Russian medical device certification
2023 / 05 / 29
Russia implements compulsory for medical device registration management regulation, mainly by the Russian federal supervision bureau (Roszdravnadzor) is responsible for http://www.wiselinkchina.com/. Medical device registration is divided into two types: registration certificate and registration statement. Certificate of registration The registration certificate is a mandatory audit and registration procedure for high-risk medical devices, medium and high risk medical devices and certain low-risk medical devices. After obtaining the registration certificate, they are allowed to be sold and used in Russia. Documents required for registration include medical device design, technical documents, product labels and instructions, product manufacturing qualifications and clinical test reports. The registration statement applies to low-risk medical devices and does not require a Russian registration certificate. However, the applicant will need to submit legal documentation and ensure that the product complies with relevant Russian standards and regulations. Russian device registration process Determining the classification and grade of medical devices; Submit the application for certification and registration, submit risk analysis documents, technical documents, test reports and other relevant materials; Preliminary audit by Russian certification authority, including sample testing and production site inspection; Obtain the registration certificate, including the technical parameters of medical devices, certification standards, registration certificate number and other information; During the validity period of the registration certificate, the annual inspection and report update should be carried out. Specifically, the detailed process for certification registration of medical devices may v
South African Medical Device SAHPRA registration
2023 / 05 / 19
South Africa's medical device market has huge potential for Chinese companies. South Africa's medical market is relatively mature, with high medical level and demand. Meanwhile, there is a big difference between urban and rural areas, and there is a large number of grassroots medical institutions and medical equipment gap. The South African government attaches great importance to medical and health care, and medical expenditure has steadily increased. In addition, South Africa is one of the economic and commercial hubs in Africa, which means that access to other African markets through South Africa is also great. The short name of South Africa Medical Device Registration is SAHPRA, the full name of South African Health Products Regulatory Authority (South African Health Products Regulatory Authority). It is the official body responsible for the registration, regulation and approval of medical devices, health products and cosmetics in South Africa. Registration of medical devices in South Africa must be approved by the SAHPRA and meet its standards and regulations before they can be sold and used in South Africa. Therefore, understanding the relevant regulations, processes, and requirements of SAHPRA is very important for businesses registering medical devices.
2023 / 05 / 13
Recently, the global COVID-19 pandemic has renewed concerns. Not long ago, the so-called "two Yang" cases appeared in some areas, making people worried about the development and control of the epidemic. So what is a case of "two Yang"? What does that mean? Second Yang refers to a person who has recovered from the virus and tests positive again within a short period of time. This has happened in several countries around the world, including China, South Korea, Japan and elsewhere. This has raised doubts about recovery and immunity from COVID-19. So, why the "two Yang" cases? Experts say this could be because the virus is still present in the body, but in such small quantities that it cannot be detected. Or a period of time after recovery when immunity drops and the virus becomes active again. However, this does not mean that those who have recovered will be reinfected with the virus or pose a risk to others. Still, the situation is causing concern. After all, the novel coronavirus is a highly contagious virus that has greatly affected the economic and social life of countries around the world. Therefore, prevention and control is still very important. We urge you to continue to take good personal protection measures, including wearing masks, washing hands and maintaining social distancing. At the same time, governments should strengthen surveillance and control to ensure that the epidemic does not spread again. Apart from the two Yang cases, other aspects of the COVID-19 outbreak are also worrying. In particular, new strains of the virus have recently emerged that spread faster and are more capable of infecting. This poses new challenges to global epidemic control and prevention. However, we should also note that countries around the world have taken proactive measures to prevent and control the disease, including strengthening quarantine, re
2023 / 04 / 24
On April 22, the China Center for Disease Control and Prevention released the latest situation of the novel coronavirus infection in the country. Compared with the data released by China Disease Control and Prevention on April 15, from April 14 to April 20, 12 newly detected local mutant strains of major concern were detected. Since December 9, 2022, the positive number and positive rate of COVID-19 nucleic acid testing in all provinces showed a trend of first increasing and then decreasing. The positive number peaked on December 22 (6.94 million), then fluctuated and dropped to 2,661 on April 20, 2023. The positive rate peaked on December 25, 2022 (29.2%) and fluctuated down to 1.7% on April 20, 2023. From September to early December 2022, the weekly number of influenza-like cases (body temperature ≥38℃, accompanied by cough or sore throat) in influenza sentinel hospitals across the country remained stable at around 100,000, and the ratio of influenza-like cases to outpatient (emergency) patients fluctuated between 2.7% and 3.6%. In 2023, the proportion of influenza-like cases began to increase (1.8%) in the 7th week (February 13-19), peaked (9.1%) in the 10th week (March 6-12), and then continued to decrease to 5.8% in the 15th week (April 10-April 16). From December 1, 2022 to April 20, 2023, a total of 32,993 valid genome sequences of COVID-19 cases were reported nationwide, all of which were Omicron variants, covering 117 evolutionary branches. The main endemic strains were BA.5.2 and its subbranches (64.3%) and BF.7 and its subbranches (33.0%). The epidemic is coming, please use Zhejiang Lanhine medical medical face mask, bandage face mask, N95 face mask,medical face shield.
ASTM Level 1 (Low) Rated Medical Masks
2023 / 04 / 14
ASTM Level 1 (Low) Rated Medical Masks Light / minimum BFE & PFE protection used for general procedures, minimally invasive surgery, ophthalmology, and respiratory etiquette. BFE at 3.0 micron ASTM F2101 ≥ 95% PFE at 0.1 micron ASTM F2299 ≥ 95% Delta P < 5.0 mm H2O/cm2 Fluid Resistance to Synthetic Blood at 80 mm Hg Flame Spread Class 1 per 16 CFR part 161
We invite you to attend the CMEF Medical Device Expo in May
2023 / 04 / 09
May 14-17, 2023, the 87th China International Medical Devices Expo (Spring). The Shanghai CMEF exhibition has attracted more than 4,000 brand companies from all over the world.
2023 / 03 / 31
Raids at the airport in Liege (LGG), Belgium, revealed an alleged import VAT fraud worth €310m by Chinese exporters. This incident also triggered the cross-border e-commerce sellers, freight forwarding logistics industry "great turmoil", foreign trade people export logistics may be rewritten. In the fraud, a Belgian customs broker acting on behalf of Chinese exporters is alleged to have wrongly declared that Chinese goods entering Liege airport were destined for other EU countries and therefore enjoyed duty-free treatment. On March 28, the European Public Prosecutor's Office (EPPO) carried out 10 raids in various locations, including Liege airport, and arrested 4 suspects. The raids focused on companies active in international freight, importers and exporters, suspected of evading at least 310 million euros (VAT+ duty).
RMB trading volume surges in Russia!
2023 / 03 / 24
The Chinese yuan surpassed the US dollar for the first time in February to become the largest currency in monthly trading volume on the Moscow bourse, Kommersant reported, citing the latest data from the bourse. Foreign currencies such as the US dollar and the euro declined in Russia in 2022, while the Chinese yuan is becoming one of the most popular foreign currencies in Russia. Analysts pointed out that China's steady economic growth has laid a solid foundation for the internationalization of the RMB. The RMB has become more and more popular in Russia due to the quantitative and qualitative improvement of China-Russia economic and trade cooperation. Western countries imposed sanctions on Russia, also accelerated Russia to reduce dependence on the dollar, the euro. The RMB exchange rate is stable, as an international currency hedging attributes increasingly prominent. Since 2022, influenced by the tightening of monetary policy of the US Federal Reserve and the ongoing conflict between Russia and Ukraine, the exchange rates of the euro, yen and other currencies have fallen sharply against the US dollar, while the relatively strong performance of the RMB has become more attractive to Russian investors. Vladimir Sagalaev, a Russian financial analyst, said that the RMB has important international influence and is much less at risk from external economic pressure than many national currencies.
2023 / 03 / 17
The UK Medicines Regulatory Authority (MHRA) and a number of government agencies have issued an update on their progress following the December 2022 joint statement. Relevant advisory groups have been established to reach consensus on international recognition, innovation routes and system capacity, demonstrating that the issues have been effectively addressed. Next, officials plan to evaluate the proposals from the advisory group by the end of April 2023 to ensure they meet relevant requirements and standards. The ICAR agreed that in order to simplify the registration process for medical devices and reduce regulatory costs for small and medium-sized manufacturers, it is necessary to establish an equivalent path for medical devices certified by a credible regulatory body to avoid the burden of repeatedly submitting relevant information to multiple regulatory bodies. Solutions to consider include: Based on the current EU CE certification basis Establish parity with trusted regulatory agencies, such as the US FDA, for most products
2023 / 03 / 10
A total of 491 factories closed in Cambodia last year, leaving 59,000 workers without jobs, due to a drop in orders from Europe and the US, the Cambodia-China Times reported. Another 100 factories suspended production. Most of the factories that have closed or stopped production are garment factories, mainly because of falling orders in the U.S. and European Union and a lack of raw materials, according to Labor Ministry spokesman Hsing Sot. In the first two months of this year, 71 factories suspended production More than 30,000 workers were temporarily laid off As of February 28, 71 factories had suspended production, leaving 32,023 workers temporarily unemployed, Cambodian Labor Ministry spokesman Hsing Sot told the Cambodia-China Times on Saturday. Of the 32,023 workers, 81 percent, or 26,055, are women, Shinso told reporters. Of the 71 factories, 34 are in Phnom Penh, employing 10, 010 people, he said. 37 are in other provinces, with 20,013 workers. Demand for finished clothes in the European Union and the United States is shrinking Cambodian foundries were the first to be hit A spokesman for Cambodia's Labor Ministry said that weak demand in Europe and the United States has become an impor
2023 / 03 / 03
The "CE" mark is a kind of safety certification mark, which is regarded as the manufacturer's passport to open and enter the European market. The goods affixed with the CE mark indicate that they meet the requirements expressed in a series of European directives on safety, health, environmental protection and consumer protection. All products labeled with the "CE" mark can be sold in the EU member states, without meeting the requirements of each member state, thus realizing the free circulation of goods within the EU member States. In the European Union market, the "CE "mark is a mandatory certification mark. Whether the products produced by enterprises in the European Union or products produced in other countries, if the products are to be sold in the European Union market, On free circulation, a "CE" mark must be attached to show that the product meets the basic requirements of the EU directive on New Methods of Technical Harmonization and Standardization. This is a mandatory requirement for products under EU law. The relevant directive requires that the industrial products affixed with the CE mark, without the CE mark, shall not be sold on the market, has affixed the CE mark into the market, found not to meet the safety requirements, to be ordered to recover from the market, continuous violation of the directive on the CE mark provisions, will be restricted or prohibited from entering the European Union market or forced to withdraw from the market.
Hong Kong Face mask ban lifted from 1st March 2023
2023 / 03 / 01
The Hong Kong government has lifted its ban on face masks in the city. The ban, which was imposed in October 2019, was put in place to deter people from protesting and to prevent the spread of the coronavirus. The ban was widely criticized by human rights activists and pro-democracy protesters who argued that it was an attack on freedom of expression. The Hong Kong government has now lifted the ban, saying that it was no longer necessary given the improving situation in the city. The lifting of the ban will come as a relief to many protesters who have been using face masks to protect their identity while participating in demonstrations.
The Yuan has depreciated about 2% against the US dollar in a month. What will happen in the future?
2023 / 02 / 28
After rising for months and hitting a near six-month high in early February, the renminbi has suffered a bout of volatility in recent days. From February 1 to February 24, the central parity rate of the RMB against the US dollar has depreciated by 1,450 basis points, according to the China Foreign Exchange Trade System. The renminbi has depreciated by about 2 per cent in the past month. Against the backdrop of pressure on the renminbi, some people worry that the exchange rate will continue to fall. In this regard, experts said that the overall pattern of two-way volatility of the renminbi, the trend is stable. In the future, there will be more positive factors supporting the RMB exchange rate. Will there be another wave of devaluations? The RMB exchange rate fluctuates, and some people worry that there will be a new wave of depreciation of the RMB. Zhou Maohua, macro researcher of financial market department of Everbright Bank, told the media that the RMB exchange rate has fallen against the US dollar, but it is still a strong currency. The RMB has appreciated against other countries' currencies, and since February, the RMB has shown a two-way fluctuation pattern and a stable trend. Wang Youxin believes that from the future trend, the Fed rate hike policy may continue until May, until then, the dollar index will get some support from the tightening policy. "Of course, with the increase of the peak interest rate, the negative impact of the Fed's interest rate hike policy on the economy will continue to accumulate and emerge. Although the US economy is slowing down, the economic downward trend remains unchanged. Therefore, around the May interest rate meeting may become the key time point for the change of the trend of the international foreign exchange market. After that, there will be more positive factors supporting the RMB exchange rate as external constraints weaken." Wang Youxin said. China will insist
2023 / 02 / 21
The trend in face mask development has been towards lighter, more comfortable, and more effective designs. This has been driven by the need for face masks to be worn for extended periods of time, and the desire for better protection against airborne particles. Companies have developed masks with advanced filtration systems, breathable fabrics, and adjustable straps for a more comfortable fit. Many masks are now designed with antimicrobial properties and can be reused multiple times. There has also been an increase in the number of fashion-forward designs, allowing people to express their personal style while still protecting themselves and others.
Lanhine first publish-medical protective face mask for Child 8-15 years ,standard GB19083
2023 / 02 / 20
Specifications: Medical protective face mask, standard GB19083-2010 size : 135mm*110mm Packing: independent plastic bag /OPP bag Structure: mask body, nose clip, mask belt, hook and sponge strip. The mask body is composed of inner and outer non-woven cloth and middle double-layer water electret melt-blown cloth Sterilization method: EO sterilization/non-sterilization advantages: 1.Ultra-low gas resistance, only 1/4 of the standard; 2.It is the first in the industry to wear both head and ear; 3.Sponge strip design of nose bridge, anti-fog and anti-leakage, safer. 4.Four layers of protection, double layer filtration; 5.Skin friendly material, comfortable and soft; 6.3D cutting, more comfortable breathing;
2023 / 02 / 17
Canada increases the medical device license review fee, which takes effect in April Canada has strict guidelines and is one of the best medical device regulatory systems in the world. As one of the few countries in the world that do not need to assign local representatives, Canada is very attractive to many foreign manufacturers. In addition, as one of the original member countries of GHTF (Global Medical Device Coordination Working Group), Canada's certified products have been recognized in many countries such as Southeast Asia, the Middle East, South America and Africa, or can help to quickly review the registration. Therefore, whether it is exported to Canada or not, this Canadian certificate with high gold content deserves your attention. Health Canada updated the list of medical device shortage notices Health Canada has updated the list of medical device shortage notices on February 7, 2023 https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/shortages/mandatory-reporting.html- To increase the number of medical devices that require mandatory reporting by manufacturers and importers. For more information about medical device shortage report, please refer to: Web page of medical equipment shortage: https://www.canada.ca/en/health-canada/services/drugs-health-products/medicaldevices/shortages.html Reporting Guide for Shortage and Use Interruption of Medical Devices (GUI-0137): https://www.canada.ca/en/hea
Lanhine medical offer design scheme
2023 / 02 / 15
More and more enterprises choose customized masks to protect their employees and customers with love. Customized masks are also mobile propaganda stations of enterprises. Wherever the people wearing customized masks go, they are like mobile billboards, conveying the values and corporate culture of enterprises.
N95, FFP2, KN95, KF94- What is the difference between these respirators and masks?
2023 / 02 / 08
Recently with more COVID-19 variants emerging and spreading to different countries worldwide, people are feeling the need for extra protection extreamly. With so many different types of face masks on the markets to choose , which one is the right one for you? Lanhine medeical make surgical medical face mask, kids face mask, face shield, wound care and personel care products. Most people don`t realize that different countries have different standards for these respirators. We`re here to give you a quick comparison and clarify the key differences! N95 (United States NIOSH-42CFR84) FFP2 (Europe EN 149-2001) KN95 (China GB2626-2006) KF94 (Korea KMOEL – 2017-64) Certification/ Class (Standard) N95 (NIOSH-42CFR84) FFP2 (EN 149-2001)
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Ms. Winnie He
Tel:+86-0574-63970706
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Mobile Phone:+8613566524353
Email:sales01@lanhine.com
Address:1989 Cidong Road, Cidongbinhai District,, Ningbo, Zhejiang
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Privacy statement: Your privacy is very important to Us. Our company promises not to disclose your personal information to any external company with out your explicit permission.