Medical device regulation latest news

Medical device regulation latest news. The new regulations will put patient safety first and help to ensure Dec 9, 2022 · LONDON - The EU Health Commissioner on Friday proposed delaying the deadline for companies to comply with a new law regulating medical devices from 2024 to as late as 2028, a major change she said May 15, 2024 · Updates to Medical Device Licensing Requirements. 6025 – 880. The majority of documents on this page are endorsed by the Medical Device Coordination Group (MDCG) in accordance with Article 105 of the MDR and Article 99 of the IVDR. To ensure patient safety and Jun 15, 2020 · The new device regulation helps Anvisa better focus on high-risk medical devices, especially considering that class I applications account for more than 30 percent of its evaluation requests. The two new regulations will come into full application in May 2020 for medical devices and May News. 28TH GHWP ANNUAL MEETING IN KUALA LUMPUR, MALAYSIA . Aug 22, 2024 · Medical Device Regulation; Safety Information; Status of Medical Device; All news . Scope of regulation. 5970: Subpart G: General Hospital and Personal Use Miscellaneous Devices: 880. 1 and amended Regulation 5. This marks a significant shift from the earlier regulation where only 35 device categories needed registration. Policy & Regulation; M&A; identifiers are hurdles to expanding an FDA system to monitor medical device safety Report from the Commission to the European Parliament and the Council on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices, COM(2022)182 final of 26 April 2022. 751/2022 on Sept. Food and Drug Administration (FDA) develops and administers regulations under authority granted by laws passed by Congress that Jul 5, 2023 · India is on course to introduce regulations governing all the medical devices in the country on October 1, Drugs Controller General of India Rajeev Singh Raghuvanshi said at iPhex 2023 Medical devices regulation and safety; Latest information for patients; For real-time updates including the latest press releases and news statements, see our Twitter channel at https: Feb 21, 2024 · The regulation approved by EU member-state representatives today amends the legislation on medical devices, including in-vitro diagnostic medical devices (IVDs), by: further extending the transition period for certain IVDs (particularly those that are high-risk) Jun 13, 2023 · Europe is facing a medical device gridlock as companies wait to have old and new products certified under the recently enforced Medical Device Regulation. Events . RDC 270/2019 also aligns with similar rules established by regulators who are members of the International Forum of Medical Device Regulators (IMDRF) and Medical devices to be suitable for intended purpose. 2017: 2017-Apr-13 Jul 12, 2021 · The new EU Medical Device Regulations (MDR) and in vitro Diagnostic Regulation (IVDR), 2017 make notified bodies, competent authorities and the European Commission more responsible than ever before for the safety of medical devices, including in vitro Diagnostics. The new RDC consolidates medical device risk classification, the Notification and Registro regimes (including registration modification requirements), and the requirements for medical devices’ labeling and instructions for use for all risk classes. Approvals and clearances, information on medical devices by type. The new regulation replaces the previous Directive 2006/66/EC on batteries&nbsp;and aims at regulating the entire battery life cycle and value chain in an integrated manner. Federal government websites often end in . Products and Medical Procedures. 2930: Subparts D-E [Reserved] Subpart F: General Hospital and Personal Use Therapeutic Devices: 880. Pagination Page-1 Page 1 of 27 Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in vitro diagnostic medical devices. 23 MB, 34 pages) Medical Device Regulations Update – HSE Presentation 15/09/2021 (PDF, size 500 KB, 18 pages) MDR implementation 2021 Jul 16, 2022 · Regulation of medical devices as a separate category and not as a drug have finally been laid out under a draft ‘Drugs, Medical Devices and Cosmetics Bill, 2022’ released by the Ministry of May 26, 2021 · On 19 May 2021, the Federal Council approved supplementary provisions to the implementing regulations on medical devices. Pagination Page-1 Page 1 of 41 Jan 31, 2024 · Device Advice. 29. XML Full Document: Medical Devices Regulations [437 KB] | PDF Full Document: Medical Devices Regulations [873 KB] Regulations are current to 2024-06-19 and last amended on 2024-01-03. Introduction to Medical Device Labeling Label vs. August 27, 2024. Before sharing sensitive information, make sure you're on a federal government site. Learn more about us through this short video May 8, 2023 · The Press Release underlined the crucial nature of the medical devices industry by stating that the estimated market-size of the medical devices sector in India was $11 billion (approximately, ? 90,000 Cr) in 2020 and its share in the global medical device market is estimated to be 1. We use cookies in order to ensure that you can get the best browsing experience possible on the Council website. Aug 29, 2024 · Emergo by UL examines Battery Regulation 2023/1542 in Europe, and how medical device manufacturers will be impacted in terms of compliance. 7. EMA has updated guidance and Q&A on quality requirements for medical devices in human medicines. gov or . 412 posted. Medical Devices - Sector. Review. May 8, 2023 · The Press Release underlined the crucial nature of the medical devices industry by stating that the estimated market-size of the medical devices sector in India was $11 billion (approximately, ? 90,000 Cr) in 2020 and its share in the global medical device market is estimated to be 1. Feb 28, 2019 · Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) replace the three existing medical device Directives (93/42/EEC, 98/79/EC and 90/385/EEC) and came into force on 25 May 2017. of Medical Devices(No. In one study opens in new tab/window 1 of medical device leaders, gaining market approval for new products (40%) and ensuring compliance with a regulatory body (47%) were identified as top priorities. Within the context of a robust health system they ensure access to safe, effective, and high-quality medical devices that prevent, diagnose, and treat disease and injury, and assist patients in their rehabilitation. Feb 14, 2023 · The Brazilian Health Regulatory Agency (ANVISA) issued the new medical device regulation RDC No. Jan 31, 2024 · The FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Aug 29, 2024 · MHLW Pharmaceuticals and Medical Devices Safety Information No. Principle 6 May 22, 2023 · The story so far: On April 26, the Union Cabinet approved the National Medical Devices Policy, 2023. Events. Findings Since Congress and the FDA initiated premarket review of medical devices in 1976, some fundamental innovations in the device regulation system have included special pathways to accelerate availability of investigational devices, more flexible evidence and review requirements, and increased funding to the FDA through industry-paid user May 6, 2017 · definition of a medical device or are covered by this Regulation. The Medical Device Coordination Group (MDCG), which has many responsibilities in the new Regulation, has now been established. The European Committee for Standardization (CEN) published CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and the European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation. Jul 3, 2024 · 1. 3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations). 5%. (Nasdaq:ITMR) (TASE:ITMR), a company that develops, manufactures and markets non-invasive diagnostic medical devices for sleep apnea with a focus on the cardiology market, today announced that it has received 510(k) clearance from the U. Revisions of PRECAUTIONS: Sodium valproate, etc. These are… Latest updates News announcement Collecting clinical evidence for your medical device doesn’t end once you’ve received your Conformité Européenne (CE) mark. Legislation We regulate medical devices in Singapore under the Health Products Act (HPA) and its Health Products (Medical Devices) Regulations 2010. This white paper outlines clinical evidence and study design considerations in the post-market phase to ensure your device complies with European Medical Device Regulation 2017/745 (EU MDR) in its entirety. Principle 4 Long-term safety. 04. The government intends to introduce new regulations for medical devices that prioritise patient safety, give patients access to the medical devices Oct 5, 2023 · Recently-Approved Devices. Itamar Medical Ltd. Jan 25, 2020 · The implementation of the new medical device regulations require Class B, C and D Notified devices (as in listed in FDA Memo 2014-005) obtain a Certificate of Medical Device Registration (CMDR) by February 7, 2020. Frequently Asked Questions; Designated bodies; Standards and common specifications; Foreign inspections; Applicable EU legal acts; Roundtable on Medical Technology (RTMT) Legal framework; Information from the European environment On 23 July 2021 the Government repealed Regulation 4. 5025 – 880. 2017: 2017-Jun-02: 1125 KB: 26: MEDICAL DEVICE ALERT FOR " Beacon Tip Torcon NB Advantage Catheter: 2017-Jun-02: 1125 KB: 27: Medical Devices alert 13. Implementation of the future regulations. EU Health Commissioner Stella Kyriakides seeks to pair the delay with “additional measures to address the structural problems” of MDR, including the need for targeted solutions Jan 11, 2023 · The European Commission developed the new proposal following a December 9, 2022, meeting of the EPSCO Council, where EU Ministers of Health called on the Commission to swiftly submit a proposal to extend the transition period in the Medical Device Regulation. Information Briefing Medical Device Regulations (vimeo video, length 1hr. 2022-52, July 29, 2022) 의료기기 허가/신고/심사 등에 관한 규정(2022. 21, 2022. All the Regulatory Update for your Medical Device Industry with Easy Medical Device. Factsheets The EU Competent Authorities for Medical Devices (CAMD) have also published FAQs specifically on the transitional arrangements: MDD to MDR and IVDD to IVDR. Jun 26, 2022 · The EU Medical Devices Regulation (2017/745) (EU MDR) therefore took effect in Northern Ireland on 26 May 2021 and the in vitro Diagnostic Medical Devices Regulation (2017/746) (EU IVDR) took Aug 23, 2024 · Stay up to date with Asia Actual's latest medical device regulatory updates to keep you informed on the ever changing medical device requirements in Asia. Safety. FDA’s Role • Oldest comprehensive consumer protection government agency • Promote and protect health • Covers foods, drugs, biologics, cosmetics (5) To the extent possible, guidance developed for medical devices at international level, in particular in the context of the Global Harmonization Task Force (GHTF) and its follow-up initiative, the International Medical Devices Regulators Forum (IMDRF), should be taken into account to promote the global convergence of regulations which contributes to a high level of safety protection MEDICAL DEVICE ALERT FOR " Absorb Bioresorbale Vascular Scaffold BVS and Absorb GT1 Bioresorbale Vascular Scaffold BVS : 2017-Jun-28: 1274 KB: 25: Medical Devices alert 02. The European Council has extended deadlines so that existing devices will not disappear from the market, but the ever-lengthening wait for certification is crippling start-ups that need approval in order to attract investors and move their Oct 28, 2022 · The regulator said it was “introducing a 12-month extension to the implementation of the future Medical Device Regulations, with an aim to bring the new regulations into force by July 2024” to ensure the new system of regulation is ready in time and to minimise the risk of supply disruptions for UK patients. ) Note: MFDS offers the English version as a service to an international audience. Now all the medical devices need to be reassessed for compliance and certification. The MHRA presented a webinar on the UK Medical Devices Regulations on January 24, 2023. Food and Drug Administration (FDA) published its new and final Quality Management System Regulation (QMSR), amending the good manufacturing practice requirements of the Quality System Regulation (QSR) for medical devices to align more closely with the international consensus standard ISO 13485:2016, Medical Aug 13, 2024 · Explore the latest news and expert commentary on Medical Device Regulations, brought to you by the editors of MDDI. The three classes are: Class I Feb 22, 2022 · On February 23, 2022, the FDA issued a proposed rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with Since 2001, the regulation of medical devices in Switzerland has been equivalent to that in the EU. Fees and Charges for Medical devices 146 7. It is listed in the register of Commission expert groups as The new Medical Devices Regulation (EU) 2017/745 Latest updates. Comprehensive List of Latest CDRH Updates. A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions. Dec 12, 2022 · The European Union Health Commissioner has proposed delaying enforcement of the Medical Devices Regulation (MDR) by three to four years to prevent product shortages. Digital Health Center of Excellence Jan 26, 2023 · For medical device makers – and the patients who rely on them – 2023 is poised to be a year of challenge and change for regulation. 6992 Mar 29, 2021 · The regulations, which introduce changes to the existing Order No. Applies to all medical devices. posted. Int. The new product mark to be used for medical devices placed on the market in Great Britain is the UKCA mark. These Regulations contain the legislative measures necessary for the implementation of three European Community Directives: Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; Council Directive 93/42/EEC concerning medical devices, as amended; and Directive 98/79/EC of the European Parliament and of the Jun 24, 2021 · On May 26, 2021, the EU Medical Device Regulation (EU no 2017/745, MDR) has come into effect. 57min) Medical Device Regulation – HPRA Presentation 15/09/2021 (PDF, size 1. The impact will be felt not only by the usual battery-driven The Medical Device Regulation was officially published on May 5, 2017, and came into force on May 25, 2017. S. New. Aug 20, 2024 · Emergo by UL examines Battery Regulation 2023/1542 in Europe, and how medical device manufacturers will be impacted in terms of compliance. gov means it’s official. . The market size of the medical devices sector in India is estimated to be $11 billion (approximately, ₹ 90,000 Cr) in 2020 and its share in the global medical device market is estimated to be 1. Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on In Vitro Medical Devices (IVDR) require the European Commission to create expert panels to support scientific assessment and advice. While the US has a centralized governmental authority, the Food and Drug Administration (FDA), the EU implemented a system of different Notified Bodies responsible for the approval process of medical devices. ) (Amendment) Regulations 2024 and to include information on MDCG guidance on the Health Institution Exemption. Principle 5 Medical devices are not adversely affected by transport or storage. Applies to all medical devices for the intended lifetime of the devices, however long or short that may be. Incident Response Playbook: Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook is a playbook that describes the types of readiness Jan 13, 2024 · Today, a clear path ahead has been set out for the development of new and robust regulations for medical devices in the UK. Jan 24, 2023 · By Karen Hill and Evangeline Loh. PMDA’s Support to Venture Companies posted. The webinar featured the staff of the MHRA updating on the current regulatory background; expected dates of future statutory instruments (SI); the role of the focus groups in developing additional guidance; the status of Approved Bodies (AB); as well as “ensuring May 21, 2024 · A new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of medical devices has been published today. Any discrepancies or differences created in the translation are not binding The Medical Devices Regulation (EU) 2017/745 has been applicable since May 2021 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 is due to apply from May 2022. The policy endeavours to facilitate an orderly growth of the sector and in turn, achieve the Jan 5, 2023 · primarily responsible for medical device regulation. 650, feature differences from the draft version published in 2018. Jul 18, 2023 · The regulatory landscape for medical devices is continuously evolving to ensure patient safety, device effectiveness, and market transparency. Currently approved medical device manufacturers had an initial three-year transition time to May 26, 2020, which was changed to May 26, 2021, to meet regulatory requirements. List of Auditing Organizations (AO) recognized by Health Canada under section 32. Guidance on grouping of medical devices for product registration 141 7. This question-and-answer document provides practical considerations on the implementation of the medical devices and in vitro diagnostic regulations for combinations of medicinal products and medical devices. The legal permission to do this comes from the Medicines and Medical Devices Act 2021 , and that requires us to do certain things, including undertaking a full Dec 31, 2020 · The EU Medical Devices Regulation and EU in vitro Diagnostic Medical Devices Regulation Since 26 May 2021, the EU Medical Devices Regulation (Regulation 2017/745) (EU MDR ) has applied in EU Medical Devices Directorate Quarterly Performance Report for Q2 2022-23 [2022-12-01] November. Oct 28, 2022 · New medical device regulations notification to WTO: early 2023 New medical device regulations laid before parliament: Spring 2023 New post-market surveillance requirements: Spring 2023 New medical device regulations come into force: July 2024 Timeline for new transitional periods commence: July 2024. 2200 – 880. Aug 21, 2024 · Up-to-the-minute news and updates from the European MDR & IVDR compliance experts. Dec 16, 2022 · Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified… Latest updates News announcement 6. May 30, 2024 · The Council has adopted a regulation amending the rules governing medical devices and in-vitro diagnostic medical devices, with a view to preventing shortages. August 22, 2024. Stay up-to-date on the latest research and news on medical devices, including the increasing use of artificial intelligence in healthcare. Call for PMDA-ATC Medical Aug 25, 2022 · ON 11 JANUARY 2022, Regulation (EU) 2021/2282 on health technology assessment (HTA) came into force. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance. 06. Nov 3, 2023 · Cybersecurity News and Updates. Companies in the medical technology sector are currently facing a triple witching hour for medical device regulatory compliance. A post-COVID-19 surge in applications for review and the burgeoning role of artificial intelligence and machine learning — combined with swift advances in monitoring technology and wearable sensors — have May 26, 2021 · The Medical Device Regulation (MDR) entered into application in the EU on 26 May 2021, changing the legal framework for medical devices. 2 Audit fee of Notified Bodies under Medical Devices Rules, 2017 148 8. mil. The transition has not been seamless, as shown by repeated extensions of compliance deadlines. Labeling. Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling and reporting requirements. Mar 5, 2021 · Policies, strategies, and action plans for health technologies, specifically for medical devices, are required in any national health plan. The Swiss provisions resulting from the new regulations entered into force on the date of application of, respectively, the Oct 19, 2023 · <p>On July 12, 2023, the hotly anticipated new Regulation (EU) 2023/1542 on batteries and waste batteries&nbsp;(&ldquo;Batteries Regulation&rdquo;) was adopted. August 2024 – Volume 21, Issue 3 31st July 2024-Snapshot of the August 2024 issue of the Journal of Medical Device Regulation: Japan: PMDA overview of the review systems for innovative medical devices in Japan Sustainability: Medical device regulation in a changing world of sustainability awareness Meeting Report: MedTech… Read More Medical devices are assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. Aug 17, 2023 · Press statements, meetings, conferences, and other announcements to keep the public apprised of significant news and activities related to medical devices. 1 of the Medical Devices Regulations (MDR) [2022-11-30] Summary reporting provisions of the Medical Devices Regulations: Notice to industry [2022-11-21] The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for EMA and national competent authorities in the assessment of certain categories of medical device. Information about a Medical Device 151 Apr 21, 2021 · Class IIb implantable medical devices must be registered by 30 April 2021; Class IIb non-implantable medical devices must be registered by 31 August 2021; and; Class I medical devices must be registered by 31 December 2021. Events; Information on specific medical devices; Archive; Regulation of medical devices. Learn about the latest device approvals, including what medical uses the device is cleared or approved for, when it can be used, and when it should not be used. 1 The regulation is the culmination of a long debate between European Union (EU) Member States and health sector stakeholders, triggered by joint actions such as European Network for Health Technology Assessment (EUnetHTA) and formalised through the European Commission (EC)’s proposal in Jun 28, 2022 · Transitional arrangements devices that are CE marked under the EU Medical Devices Regulation (MDR 2017/745): This transitional arrangement for medical devices will allow, at a minimum, products to be placed on the market until either the certificate expires or for five years after the new regulations take effect, whichever is sooner. The changes we’re making will update those regulations. News announcement; 26 July 2024; Dec 6, 2023 · The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. Medical device manufacturers—and, in some cases, user facilities, device labelers, and importers—are subject to a number of requirements to ensure that devices are not adulterated or misbranded and to otherwise assure their safety and effectiveness. New regulations from the European Union, Canada, and the United States are being implemented simultaneously, and they will impact companies' bottom lines. FDA Regulation of Medical Devices 4. We require companies to obtain a dealer's licence before manufacturing, importing or supplying medical devices. Jan 9, 2024 · Under those regulations, it’s possible, now, to apply through a UK Approved body, to get a UKCA marking for a medical device. Emergo by UL experts have conducted an initial review and identified the new information about the regulations that medical device manufacturers and importers will need to know. STAT Medical Mevices: News on Development, Regulation and Use Notice to industry: Medical devices contained in electronic health record (EHR) products; Summary reporting provisions of the Medical Devices Regulations: Notice to industry; Licences; Quality Systems ISO 13485; Standards; Fees for Medical Devices; Projects; What's new: Medical devices; Medical Devices Action Plan – stakeholder meetings and Regulation on the Permission, Notification, Review, Etc. Aug 21, 2023 · The . Consider the regulation of medical devices. Guidance updated: Regulation of devices in Northern Ireland - Updated to reflect the coming into force of The Medical Devices (In Vitro Diagnostic Devices etc. The MDR contains specific rules for the submission, review and conduct of clinical investigations with medical devices. Seminar schedule has been updated. We strategically accelerate international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices that is responsive to emerging challenges while protecting and maximizing public health and safety. Likewise, all Class A device will require a Certificate of Medical Device Notification (CMDN) at implementation. FREMONT, CA: The medical technology (MedTech) industry is vital in revolutionizing healthcare by developing innovative medical devices that improve patient care and outcomes. August 23, 2024. 6 days ago · The latest news and updates on medical devices. This means that from 28 July 2021, devices that were previously described under regulation 4. The Medical Device Rules Act expanded the number of devices requiring regulatory oversight. 1 Fee payable for licence, permission and registration certificate 146 7. The Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostics Apr 26, 2023 · The medical devices sector in India is a sunrise sector which is growing at a fast pace. Oct 1, 2023 · In May 2021, the new Medical Device Regulation in the EU came into force. These enter into force on 26 May 2021, at the same time as the completely revised Medical Devices Ordinance (MedDO) and a new Ordinance on Clinical Trials with Medical Devices (CTO-MedD). Who is ISO 13485 for? ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical Aug 17, 2023 · To highlight the capabilities of Indian Medical Devices Sector under the G-20 Indian Presidency, the first-ever expo being spearheaded by the Government in association with the Indian medical Trends and challenges in medical device regulation . Aug 26, 2024 · UGA/FDA 11th Annual Medical Device Regulations Conference - August 21, 2024; Current Career Opportunities at CDRH (Updated) Jan 31, 2024 · As of February 2, 2024, the U. The U. 1 (those that contain medicines or materials of animal, microbial, recombinant, or human It is divided into 50 titles that represent broad areas subject to Federal regulation. The proposal will now be negotiated by the European Parliament and the Council. Most of FDA's medical device and radiation-emitting product regulations are in Title 21 CFR Parts 800-1299 Aug 27, 2024 · Furthermore, the researchers found that the latest draft guidance, published by the FDA in September 2023, does not clearly distinguish between different types of clinical validation studies in General Hospital and Personal Use Monitoring Devices: 880. (12) Cer tain groups of products for which a manufacturer claims only an aesthetic or another non-medical pur pose but which are similar to medical devices in terms of functioning and r isks profile should be covered by this Regulation. Food and Drug Administration for WatchPAT One, the latest innovation of its WatchPAT technology and the first and only fully disposable Jan 9, 2024 · The government says the new regulations will put patient safety first and help to ensure that patients continue to have access without delay to the devices they need, whilst enhancing the UK’s position as a world-leading environment for medical technology innovators. Medical Device News for February 2023. All required information for investigators about the MDR is available on a theme page on CCMO’s website. snxmp ycpbk qtmxzc fwnn hvqu tmhorav pwazt dnr lnnaqu yii