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September 25, 2020

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The weekly global report provides brief updates on COVID-19 related activity and policy development in AdvaMed’s priority markets. For additional information, please contact Ralph Ives at Rives@AdvaMed.org.

COVID-19 Outbreak: Weekly Global Report for Friday, September 25, 2020

 

AdvaMed recognizes that its members, particularly those with global government affairs responsibilities, are tracking COVID-19 related developments around the world to assess the public health and economic impacts on their businesses. Knowing that companies are consuming information from a variety of sources, AdvaMed's global team would like to provide members with a weekly snapshot of the key statistics, policy developments and advocacy initiatives underway in our priority markets.  If you have any suggestions, we welcome your feedback.

 

Global

  • Weekly COVID-19 statistics- global cases reached 32 million, nearly a 2 million increase over the previous week. Deaths around the world exceeded 979,000 The countries with the most reported cases continue to be the U.S. (7 million), India (5.7 million), and Brazil (4.6 million).
  • U.S. cases exceeded 7 million with deaths increasing to 202,000.
  • Staff Contact: Ralph Ives (rives@advamed.org).

    China

    • Weekly COVID-19 statistics –China’s total COVID cases now stand at 90,416 (an increase of 125 over the previous week) and deaths at 4,738 (an increase of 1 over the previous week).Almost all new cases have been linked to foreign arrivals.
    • The State Council has called for urgent preparations to combat the virus during the autumn and winter months. Priority measures include: enhanced customs inspections (notably of “carrier” foods like fresh seafood imports), more efficient and accurate nucleic acid testing platforms, and more rigorous management of quarantined areas.
    • The Chinese economy performed better than expected in August, according to government statistics. Exports experienced a noticeable rebound in July and August, as other large manufacturing nations struggle with COVID fallout. Consumption levels have continued to rise.
    • Anecdotal evidence suggests that hospitals have been gradually resuming elective/regular surgeries and operations appear to be at 80-90% of pre-COVID levels, with this range varying by particular medical condition of the patient and geographical area.
    • U.S.-China relations remain strained. The Commerce Department on Sept. 18 released its prohibitions on WeChat pursuant to President Trump’s EO; the scope of the restrictions appear limited to U.S. territory and do not extend to WeChat activity by U.S. individuals/companies in China. The Phase One trade deal remains intact and has emerged as a key area of cooperation. China continues to make record buys of U.S. farm products, most notable soybeans.
    • Staff Contact: Kyle Churchman (kchurchman@advamed.org)

          India

          • Weekly COVID-19 statistics – 5,730,184 total cases, 966,382 active cases/91,149 deaths as compared to 5,122,846 total cases, 1,009,976 active cases/83,198 deaths last week. There are signs of a possible slowdown in the pandemic as India has begun to report more coronavirus recoveries each day than new patients. The trend began last Saturday and has lasted six days. This has helped India achieve its slowest weekly pace in the growth of active cases since the pandemic began: the number is now back below 1 million.
          • The Health Ministry on Wednesday, September 23 tweeted that India's testing capacity has surged to more than 12L daily tests. Higher testing leads to early identification of positive cases. As evidence revealed, eventually positivity rate will fall. The Ministry said that several States/UTs have demonstrated better COVID-19 response with higher Tests Per Million (TPM) than the national average.
          • Dr Reddy's Laboratories Ltd could begin late-stage Indian clinical trials of Russia's potential coronavirus vaccine in the next few weeks, an executive at the Indian drugmaker said on Tuesday. Indian trials of the Sputnik-V vaccine candidate, being developed by Russia's sovereign wealth fund, will enroll 1,000-2,000 participants and be conducted at multiple government and private hospitals across the country, Deepak Sapra, CEO for API and pharmaceutical services at Dr. Reddy's, told Reuters.
          • The Drugs Controller General of India (DCGI) has issued a new set of guidelines, focusing on safety, immunogenicity and efficacy parameters for pharma giants who are developing COVID-19 vaccines. The DCGI has said that a COVID-19 vaccine candidate should have at least 50 percent of efficacy in the Phase-III clinical trial for it to be widely deployed and adequate data informing the potential risk of vaccine-associated Enhanced Respiratory Disease (ERD) needs to be generated.
          • Hyderabad-based Bharat Biotech and US-based biotech firm Precision Virologics have jointly obtained rights from Washington University School of Medicine in St. Louis for a novel chimp-adenovirus vaccine for COVID-19. Bharat Biotech will own the rights to distribute the nasal covid vaccine, subject to regulatory approvals, in all markets except the US, Japan and Europe.
          • The Drugs Controller General of India (DCGI) approved FELUDA, the Tata CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) test, powered by CSIR-IGIB (Institute of Genomics and Integrative Biology), for commercial launch, as per ICMR guidelines, meeting high quality benchmarks with 96 per cent sensitivity and 98 per cent specificity for detecting the novel coronavirus.
          • Union Health Minister Dr Harsh Vardhan on Sunday, Sep 20, 2020 informed that over four coronavirus vaccines are in advanced stages of pre-clinical trial in India. "145 vaccine candidates across the world are under pre-clinical evaluation, around 35 under clinical trials. In India, we gave all support to 30 vaccine candidates -3 of these are in advanced trials of phases 1, 2, and 3. Over 4 in advanced stages of the pre-clinical trial," Harsh Vardhan said in the Lok Sabha during the discussion on the COVID-19 pandemic.
          • The phase-III human clinical trial of the COVID-19 vaccine developed by Oxford University and being manufactured by the Serum Institute of India (SII) will begin at the Sassoon General Hospital in Pune next week. Dean of the state-run Sassoon General Hospital Dr Muralidhar Tambe told this to PTI on Saturday, Sep 19.
          • Minister of State for Health and Family Welfare Ashwini Kumar Choubey told Rajya Sabha that there are no shortage of personal protective equipment (PPE) kits and ventilators at dedicated COVID 19 facilities across the country on Sunday, September 20 ,2020. According to data provided by the minister in the Upper House on a query raised by Trinamool Congress MP Dinesh Trivedi, India has 1.16 beds per 1,000 persons with its population estimated at 139.78 crores as per the 2011 census.
          • The contraction in the Indian economy due to the pandemic-led disruptions may disappear next year, but it can cause some irreversible damage to the economy. Although a rebound in 2021 is expected in line with the growth rates of the Indian economy in recent years, the contraction registered in 2020 is likely to translate into a permanent income loss, said ‘Trade and Development Report 2020’ by United Nations Conference on Trade and Development.
          • Staff Contact: Abby Pratt (apratt@advamed.org).

                          Japan

                          • Weekly COVID-19 statistics – 81,315 reported cases and 1,550 reported deaths compared to 78,322 reported cases and 1,503 reported deaths the previous week.
                          • The daily growth in new cases is dropping significantly compared to several weeks ago.
                          • The pandemic has had a severe impact on Japan’s hospitals. Nearly 70% of Japan’s hospitals are now operating in the red.
                          • According to a survey conducted by the Japan Public Hospital Federation of 1,481 member hospitals, patient visits in May 2020 were down by 24.9 percent, compared with one year ago.
                          • The majority of new cases are in Tokyo and are affecting people in their 20s and 30s.
                          • Japan currently has an entry ban in place for 111 countries and regions, with foreign travelers who have been to any of those areas within the last two weeks being turned away.
                          • However, reports indicate that Japan is planning to re-open entry for foreign travelers who intend to stay in the country for more than three months, with entries likely limited to 1,000 people per day.
                          • Japan's Ministry of Health has adopted priority regulatory review procedures for new COVID-related medical devices.
                          • Japan will ban purchases from foreign companies of advanced medical device companies that are deemed essential to the national security in the fight against Covid-19. This measure is based on concerns about China but applies to companies from all countries.  The government aims to ensure stable supply of essential devices that are vulnerable to contamination by infection, such as implants and dialyzers.
                          • Staff Contact:  Phil Agress (PAgress@AdvaMed.org).

                                  Korea

                                  • South Korea’s numbers are sticking in the low hundreds, with 125 new cases per day. This remains low compared to many other countries. South Korea ranks 78th in the world in both cases and deaths.
                                  • There are 23,341 total cases, 2,116 active cases, and 393 deaths. Korea is reporting 5 deaths per day, continuing unchanged in that regard from last week’s level.
                                  • South Korea’s persistent rates appear due to sporadic clusters of infections across the country. Authorities remain wary of potential increases due to the upcoming Chuseok holiday. Clusters of infections continue to pop up largely in the Seoul metropolitan area, home to nearly half of the country’s population, hampering the government’s efforts to bring the virus situation stably under control before Chuseok.
                                  • President Moon Jae-in on Thursday called on the Japanese government to work together with South Korea to seek a solution to the issue of wartime forced labor. In his first telephone conversation with the new Japanese Prime Minister Yoshihide Suga, Moon said that the two countries are each other‘s closest neighbors and that the issue should be resolved.
                                  • Some conservative groups are backtracking on their plans to hold mass anti-government rallies in central Seoul on Oct. 3, in the face of coronavirus concerns. Former Gyeonggi Province Gov. Kim Moon-soo and other conservative figures announced Thursday that they were calling off the protests scheduled to take place in Gwanghwamun on National Foundation Day and asked other right-wing groups to follow their lead. Instead of street protests, they will hold a car parade of about 200 vehicles.
                                  • The National Assembly of South Korea has selected the chiefs of Google and Netflix’s Korean operations as witnesses at the upcoming audits scheduled for October to ask questions about their business practices. According to the country’s legislative body Thursday, Nancy Mable Walker, who represents Google Korea, will be asked to testify at the Science, ICT, Broadcasting and Communications Committee’s first audit on Oct. 7.
                                  • South Korea has agreed with Vietnam and Russia to resume flights following months of suspension over the new coronavirus outbreak.
                                  • Korea is bracing for the flu season coinciding with another wave of COVID-19, which may result in a dreaded “twindemic.” It is possible to catch both respiratory illnesses at the same time and health authorities last week confirmed a local case of coinfection with influenza and the new coronavirus. Korea’s Disease Control and Prevention Agency (KDCPA) has stated that a patient had tested positive for both viruses. They indicated not much is known about the effect of the coinfection in clinical outcomes. Having more people get vaccinated against the flu will be a critical weapon in the fall and winter when the circulation of the virus peaks. Children under 18 and older adults aged 62 or above are eligible for flu shots free of charge under this year’s vaccination program. KDCPA is recommending that everyone with underlying medical conditions or otherwise at high risk of developing serious complications from the infection get a flu shot.
                                  • South Korea has finalized a supplementary budget that will draw up a 7.8 trillion won ($6.57 billion) to shore up the economy. Cash subsidies for small businesses in the amount of 3.2 trillion won are among the items to be covered. Also included are a one-off 20,000 won subsidy for telecommunications bills for all South Koreans over the age of 13. The supplementary budget is ‘tailored emergency aid focusing on the industries and groups most heavily affected.’
                                  • South Korea maintains its 2-week quarantine for all other incoming international travelers and a requirement for all inbound flights to check passengers' temperatures. Anyone with a temperature over 37.5 degrees Celsius (99.5 Fahrenheit) is denied entry. Korea has not issued any guidance on an exemption that is supposedly available. Korea has indicated all US inbound travelers will be tested for symptoms prior to being moved to quarantine.
                                  • Korea appears to be moving toward implementation of a proposal that would potentially reduce the price of certain cardiac and peripheral stents. AdvaMed is in touch with members and the medtech association in Korea and has had several discussions with the US Government on this topic. We have sent a letter to the health ministry expressing opposition to the proposal. Please contact Joseph Gatewood (jgatewood@advamed.org) if you have an interest in this matter and are not already engaged.
                                  • Resources: http://ncov.mohw.go.kr/en/. 
                                  • Staff Contact: Joseph Gatewood (jgatewood@advamed.org).

                                                 ASEAN

                                                • Weekly COVID-19 statistics – ASEAN now has 639,327 reported cases and 15,619 reported deaths compared to 585,394 reported cases and 14,304 reported deaths the previous week.
                                                • The Philippines and Indonesia account for 97.5% of the deaths from COVID-19 in the region. Indonesia’s total COVID-19 deaths now exceed 10,000, the highest level in East Asia.  The Philippines reported 5,127 deaths.
                                                • Cambodia, and Laos have each reported zero deaths, while Brunei has reported 3 deaths, Singapore has reported 27 deaths (despite having over 57,000 cases), and All of these totals are unchanged from the previous week. Thailand has reported 58 deaths, up by one from last week.
                                                • Myanmar experienced nearly a doubling of new cases and its death toll has risen from 46 to 130. Yangon has become the center of the country’s epidemic. The government has imposed a nationwide ban on dining in restaurants and tea shops, and Yangon adopted a stay-at-home order requiring all employees to work from home.
                                                • Vietnam’s outbreak in Danang several weeks ago followed 100 days without any locally transmitted cases and led to its first COVID-19 fatalities (35 reported to date). Following strong measures to contain the outbreak, the number of cases in Vietnam grew by only 3 over the past week.
                                                • Vietnam is allowing the resumption of international air routes with six countries – China, Japan, Korea, Taiwan, Cambodia, and Laos.       Visitors must test negative three days prior to departure and will be tested again upon arrival in Vietnam.
                                                • Malaysia has imposed an entry ban on citizens of countries recording more than 150,000 cases of COVID-19. International chambers of commerce, including AmCham and EuroCham, have urged the Malaysian government to reconsider the entry ban.
                                                • Elective surgeries have resumed in Thailand and Vietnam.
                                                • In Indonesia, provincial hospitals are resuming elective surgery with COVID-19 protocols in place.
                                                • Malaysia maintains limits on elective surgery except in emergency cases.
                                                • Singapore restricts most elective surgeries but allows certain procedures including cancer screening, surgical operations for advanced cataracts, flu vaccinations, and dental procedures.  The government has lifted measures requiring doctors and healthcare workers in the public and private sectors to limit their movements across healthcare institutions. 
                                                • Indonesia has lifted the ban on export of medical devices for COVID-19 purposes. At the same time, President Jokowi has called for an end to PPE imports as the country is capable of manufacturing them locally. Indonesia has produced its own rapid test called RI-GHA COVID-19.
                                                • In Indonesia, Jakarta returned to lockdown after its Governor confirmed that the capital is in crisis and needs tougher measures to battle COVID-19.
                                                • The Philippines extended its State of Calamity by a year to counter the pandemic. This extension will give national and local governments latitude to continue utilizing appropriate disaster relief funds and affords the government powers to monitor and control necessities and provide essential services to the affected populations.
                                                • The Malaysian government relaxed its recent entry ban on expatriate and professional visit pass holders from 23 countries, provided they receive approval from the Malaysian Immigration Department and a support letter from the Malaysian Investment Development Authority. 
                                                • Malaysia and Singapore partially reopened their border on August 10. Both governments have agreed to implement a Reciprocal Green Lane (RGL) and Periodic Commuting Arrangement (PCA). The RGL will enable cross-border travel for essential business and official purposes between both countries and the PCA will allow residents of Singapore and Malaysia who hold long-term immigration passes for business and work purposes in the other country to enter the country for work.  
                                                • Malaysia is considering fully reopening the Malaysia-Singapore border for daily commuters in January 2021 if conditions warrant.
                                                • Singapore announced an easing of some COVID-19 restrictions, including on business travel. A new business travel pass for senior executives with regional or international responsibilities is being piloted. Travelers on this pass would need to keep to a strict itinerary while abroad. On returning to Singapore, they would have the option of a COVID-19 test in lieu of a stay-home notice and would need to self-isolate until the results are released.
                                                • Singapore maintains agreements with Australia, Brunei, China, Malaysia, and Korea on fast-lane arrangements for essential travel.
                                                • Singapore and Japan agreed to launch a Reciprocal Green Lane for essential business and official travel between the two countries on September 18.
                                                • Thailand is planning to reopen its borders to tourism. Visitors will be subjected to domestic quarantine while in Thailand and should be tested for COVID at the beginning and end of their stay.
                                                • The Thai Government adopted a fifth phase of lockdown easing, allowing most daily activities and businesses to resume.  It has lifted the ban on international flights and allows certain categories of individuals from Japan, China, South Korea, Hong Kong, and Singapore to enter the country. The Civil Aviation Authority will still apply stringent international travel restrictions preventing the entry of tourists.
                                                • Thailand’s Centre for Covid-19 Situation Administration (CCSA) approved another extension of the state of emergency nationwide until September 30.
                                                • Staff Contact: Phil Agress (PAgress@AdvaMed.org)

                                                      Europe 

                                                      There is continued and more aggressive spiking in the case rates across the EU including Central and Western Europe. In Western Europe, cases are spiking worst in the UK and France. Spain and France are showing the most new cases, with UK third. Italy seems to be holding well with far fewer new cases, even less than Germany. Spain leads the EU in cases and the UK leads the EU in deaths, followed by Italy and France. Although not in the EU, Russia's reported numbers on COVID are problematic. Russia remains the COVID hot spot in Europe, now reporting 1,128,836 cases, with just 19,948 reported deaths.  By comparison, Italy, with much fewer (304,323) cases, reports 35,781 deaths.

                                                       

                                                      EU Chart for Sept 25th

                                                       

                                                      • New daily cases, which tend to show which countries are increasing in COVID incidence are as follows:  Spain 10,653 (down from 11,193 last week,, Spain was at 11,289 yesterday); Italy 1,786 (up from 1,640 last week) Germany 681 (down from 2,021 last week); France 13,072 ( up from 9,783 last week); UK 6,187 (up from 3,991 last week); Belgium 1,823 (up from 633), Russia 6,431 (up from 5,670 last week).  France. Spain and UK are experiencing the worst spikes in Europe. Italy and Germany remain consistent and are flattened.
                                                      • New deaths per day (which tend to lag any increased infection rates) remain low and are as follows:  Spain 130; Italy 20; Germany 17; France 43; UK 37; Belgium 5.
                                                      • The World Health Organization has warned of “alarming rates of transmission” of Covid-19 across Europe and cautioned countries against shortening quarantine periods. The WHO’s regional director for Europe, Hans Kluge, said the number of coronavirus cases in September “should serve as a wake-up call for all of us.” Kluge indicated that ‘although these numbers reflect more comprehensive testing, it also shows alarming rates of transmission across the region.”
                                                      • Seven EU countries are of “high concern” because of rising virus death rates, with worrying trends in several other countries, the EU’s disease control agency warned on Thursday. The seven have “an increased proportion of hospitalised and severe cases” among older people and “increasing or high death notification rates are already observed... or may be observed soon”. The countries outlined were Spain, Romania, Bulgaria, Croatia, Hungary, Czech Republic and Malta.
                                                      • Other countries have observed rising infection rates primarily among younger people, who are less at risk of developing severe symptoms. The European Centre for Disease Control and Prevention singled out 13 European countries in this situation, including France and Britain.
                                                      • European Union officials urged member nations Thursday to move quickly to slow the latest wave of COVID-19 infections to avoid a repeat of the broad lockdowns that paralyzed the continent’s economy in the spring. EU health commissioner Stella Kyriakides said the most recent risk assessment showed that some countries are reporting more cases now than they did during the earlier peak in Europe.
                                                      • The EU prohibition against inbound travelers from the US, Russia and Brazil based on COVID concerns remains in place. Inbound travel is permitted from any of 15 approved countries and the list is updated every two weeks. The EU recommended member states gradually lift the travel restrictions for the following countries: Japan, Canada, Georgia, Australia, New Zealand, Rwanda, South Korea, Thailand, Tunisia and Uruguay.
                                                      • The European Commission has published a new, ambitious Action Plan to boost the European Union's Capital Markets Union (CMU) over the coming years. The EU's top priority today is to ensure that Europe recovers from the unprecedented economic crisis caused by coronavirus. Developing the EU's capital markets, and ensuring access to market financing, will be essential in this task.
                                                      • The UK is seeing its highest number of coronavirus cases since mass tests began.
                                                      • The UK has revealed a new job support scheme which will allow workers to receive 77% of their normal salaries for six months from 1 November. The new framework for supporting workers only applies to "viable" jobs and the government's contribution to workers' pay will fall from 80% of a monthly wage to 22%. In addition, the VAT cut for the hospitality and tourism sectors has been extended.
                                                      • People arriving to the UK from Denmark, Slovakia, Iceland and the Caribbean island of Curacao now need to self-isolate for 14 days.
                                                      • People are waiting longer for test results from England's community COVID testing centers. Only 28% received results within 24 hours in the week up to 16 September. That is down from one in three (33%) last week, and two in three (67%) the week before. More than 5% of tests took more than three days to turn around. On a more positive note, more than one million people have downloaded the government's contact-tracing app for England and Wales within its first day of release.
                                                      • UK Research and Innovation has published a press release outlining that life science companies can find out more about the UK’s biggest health program and opportunities to get involved by signing up for a webinar taking place on 1 October 2020. www.ukri.org.
                                                      • The prospect of a Brexit-induced queue of 7,000 trucks at Dover, each one requiring a permit to enter the county of Kent, would once have been dismissed by leave campaigners as baseless fearmongering. Now it is the government’s “reasonable worst-case scenario” for the end of transitional arrangements with the EU on 31 December. This scene was set out on Wednesday by Michael Gove, who told parliament that Britain did not yet have an operational border ready for the abrupt reintroduction of regulations and checks necessary to clear a new frontier with Europe’s customs union and single market. In a letter to cabinet colleagues, Mr. Gove noted that problems at Channel ports will arise “irrespective of the outcome of negotiations”.
                                                      • In contrast, Ireland’s foreign minister stated he believes a EU-UK trade deal breakthrough is possible in the upcoming window of several weeks, before England’s House of Lords considers the Internal Market Bill.   But he also indicated that any final trade deal between the EU and the UK would only be ratified if the EU member states are certain that the Brexit withdrawal agreement will be implemented in full.
                                                      • The UK Government continues to debate the Internal Market Bill in Commons. Even if passed, the legislation will face significant difficulties in the House of Lords. Rumors are emerging that the Government is anticipating a defeat and is considering proroguing parliament to get around this, while continuing trade talks with the EU until the stated deadline of the 15th October.
                                                      • The Department of Health and Social Care has made announcements on planning for emergency departments and social care provision over the winter. This includes an additional £150 million capital funding to expand and upgrade 25 more admission and emergency departments to reduce overcrowding and improve infection control ahead of winter; Care providers in England will benefit from over half a billion pounds extra funding to reduce COVID-19 transmission and help protect residents and staff throughout winter.
                                                      • ABHI is conducting a comprehensive analysis of the re-start of elective procedures in each Trust and Health Board in the UK. The results can be found here: https://www.abhi.org.uk/membership/members-area/updates/2020/july/the-restart-of-planned-care/.
                                                      • In Germany, Foreign Minister Heiko Maas is in quarantine after a member of his security team tested positive for coronavirus. The news came the same day as the German government called on the public to upload their results to the country's contact-tracing app if they test positive for coronavirus.
                                                      • Germany has pledged to spend 4 Billion Euros by 2026 to allow for an additional 5,000 public health workers and digitalization of public health departments.
                                                      • Lufthansa says it will test the practice of offering on-the-spot coronavirus tests before boarding intercontinental flights in an attempt to find a way to get long-haul passengers flying again. The airline said Thursday that it was working with partners in the pharmaceutical industry to obtain an accurate test that could provide results within 15 minutes for 10 euros ($12). The tests on some routes to the U.S. are to begin in October and the practice will depend on government approval. The company said the routes to the U.S. had not been decided yet. “We are in contact with various airports in North America,” the company said in a statement. One option is to make the tests a requirement for everyone boarding that flight.
                                                      • The German government said it would pour 750 million euros, equivalent to $891 million, in grants into three local companies developing coronavirus vaccines, bringing Berlin’s total bet on such research to more than €1 billion.  
                                                      • France has announced details of a 100 billion euro recovery plan. While all of the funds are earmarked for economic activity and to create jobs, a third of the funds are earmarked for green investment. This would come on top of existing measures that currently amount to around 460 billion euro.
                                                      • France is set to close all restaurants and bars in its second city Marseille, prompting anger from local officials. The move, which will come into effect from Saturday, follows a recent upsurge in coronavirus cases nationwide. France recorded more than 13,000 coronavirus cases on Wednesday, a record since restrictions were eased. But Marseille Mayor Michèle Rubirola said she was not consulted about the decision and had been left feeling "astonished and angry". The move was announced by health minister Olivier Véran on Wednesday. He said all restaurants, bars and gyms would close for at least two weeks from Saturday. Public venues such as theatres, museums and cinemas will also have to close unless they have strict anti-virus measures in place.
                                                      • If you are experiencing difficulties with exporting PPE from the EU, please let us know immediately. We have not seen any instances of this occurring since an initial incident was resolved.
                                                      • The proposed one-year suspension of implementation of the EU's MDR is now final.  The measure extends until May 26, 2021 the date of application of the current regulation but does not extend every target deadline referenced in the law.  It also creates the possibility of EU-wide derogations for specific medical devices.
                                                      • https://ec.europa.eu/commission/presscorner/detail/en/IP_20_718;
                                                      • https://www.medtecheurope.org/news-and-events/press/medtech-europe-welcomes-the-amendment-of-the-medical-devices-regulation-and-urges-similar-action-for-the-ivd-regulation/.
                                                      • AdvaMed's joint programs in Germany and the UK continue to provide COVID-19 updates and support on MDR implementation. We recently hosted joint webinars and working group calls with ABHI to give members the latest information.          
                                                      • Resources: https://www.ecdc.europa.eu/enlll.
                                                      • https://www.europarl.europa.eu/news/en/headlines/priorities/eu-response-to-coronavirus;
                                                      • https://www.gov.uk/guidance/coronavirus-covid-19-information-for-the-public;
                                                      • https://www.ecdc.europa.eu/en;
                                                      • https://ec.europa.eu/info/live-work-travel-eu/health/coronavirus-response/economy_en;
                                                      • https://www.abhi.org.uk/what-we-do/abhi-covid-19-hub/;
                                                      • https://ec.europa.eu/commission/presscorner/detail/en/IP_20_582;
                                                      • https://www.bundesgesundheitsministerium.de/en/press/2020/coronavirus.html;
                                                      • https://www.medtecheurope.org/covid-19-information-hub;
                                                      • https://www.medtecheurope.org/resource-library/european-industry-trade-and-supply-chain-needs-to-respond-to-covid-19/;
                                                      • https://www.medtecheurope.org/wp-content/uploads/2020/03 European_Union_Emergency_Support_Instrument_for_the_healthcare_sector_-_questions_and_answers.pdf;
                                                      • https://www.medtecheurope.org/resource-library/eu-materials-covid-19/.
                                                      • Med Tech Europe White Paper on Companion Diagnostics under the IVDR:         https://www.medtecheurope.org/resource-library/joint-medtech-europe-efpia-white-paper-on-companion-diagnostics-under-the-ivdr/
                                                      • Staff Contact:  Joe Gatewood (jgatewood@advamed.org)

                                                         Latin America

                                                        LATAM Chart for September 25th

                                                        Regional

                                                        • Total COVID-19 cases up 5% and deaths up 6% over the previous week.

                                                        WEEKLY HIGHLIGHTS –COVID 19

                                                        • Argentina: Political and economic agenda moves forward beyond COVID-19 issues.
                                                        • Bolivia: President Añez pulls out from the electoral campaign amid a tense political atmosphere.
                                                        • Brazil: Minister of Health confirmed in office.
                                                        • Chile: Strict sanitary measures reinforced during national holidays.
                                                        • Colombia: Ministry of Health announced agreement to join COVAX Facility.
                                                        • Ecuador: State of Emergency within the National Health System will continue.
                                                        • Mexico: The federal government requested changes to the COVAX agreement.
                                                        • Paraguay: National quarantine extended for two more weeks
                                                        • Peru: Congress votes against the removal of President Martin Vizcarra.
                                                        • Uruguay: While cases remain low, government announced drastic sanctions for disobeying sanitary protocols.
                                                        • Staff Contact: Steven Bipes (sbipes@advamed.org)

                                                         

                                                             

                                                             

                                                             

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