Medical device regulations in india pdf

Medical device regulations in india pdf. 02. Jan 24, 2017 · This paper attempts to capture information on regulations of Medical Device in three regions namely; USA, EU and India and compare provisions of Market authorization in the respective regions, and further, for the readers, make this complex subject easier to grasp. IEC . •Increase of Export. To fulfill this gap, Central Drug Standard However, the per capita spend on medical devices in India is the lowest among BRIC countries at USD 3(USD 7 in China, USD 21 in Brazil and USD 42 in Russia). Which is the Regulatory Authority that governs the regulations of Import of medical devices in India? Ans: Drugs Controller General (India), Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India , FDA Bhavan, ITO, Kotla Road, New Delhi -110002 Phone: 91-11-23236965 / 23236975, Fax: 91-11 • Potential Impact of Medical Devices Regulation, 2017/745 • To compare the detail regulations of Medical Device in EU and India to address compliance. The medical devices sector in India is a sunrise sector which 's growing at a fast Jun 4, 2024 · In India, medical device laws have improved over the past 20 years due to the growth in the quantity, variety, and complexity of medical devices. Dec 3, 2021 · The Medical Device Act of 2015 governs current medical device laws in Korea. substandard and falsified medical Mar 15, 2022 · In India, medical devices were governed by The D&C Act is a federal law that regulates the sale of drugs and cosmetic of 1940, which included specific medical device laws. METHODOLOGY The research carried out with the collected data by analyzing the terms of the below parameters: 1. (j)in vitro “ diagnostic (IVD) medical device” means any The medical device directives and the medical device regulations do not define refurbishment. e. Although these countable few success stories of medical device industry cannot make India self-reliant in medical devices, the medical device industry is changing Jan 3, 2022 · Medical devices in India are regulated under the Medical Device Rules, 2017 ("MDR") which only applies to medical devices specifically notified by the Ministry of Health and Family Welfare ("MoHFW") as regulated medical devices. The application addressed to the Drugs Harmonized regulation of medical device will lead to the availability of quality product and curtail regulatory hurdles and expedite access to high quality, safe and efficacious medical devices. To access the South Korean Medical-Device-Market, you must first obtain marketing approval from the local Medical Device Authority, the Medical Device Information & Technology Centre, which is part of the Ministry of Food and Drug Safety. 2020 GSR 754 (E) 30-09-2022 Sale of Medical Device Nov 2, 2023 · Immediately before the global focus shifted to battling the Covid-19 pandemic in March 2020, India’s regulator for medical devices, the Central Drugs Standard Control Organisation (CDSCO), issued two notifications which brought about sweeping changes to the regulatory framework for medical devices. (2018) India Medical Device Registration - CDSCO Approval. 10. 2018 vide G. Once a device is regulated under the MDR, persons engaged in the manufacture, import and sale of medical devices are Central Drugs Standard Control Organisation devices sector in India is estimated to be $11 bn in 2020 and its share in the global medical device market is estimated to be 1. Section 3 (b) (iv) defines, Medical Devices as ˝Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals ˛ Approach Paper to National Medical Device Policy, 2022 – Draft for discussions Page 4 of 37 Approach Paper to National Medical Device Policy, 2022 1 Preamble and Background 1. Per this notification, medical devices are broadly classified as investigational . O. 05. Core IV–B, Fourth Floor, India Habitat Centre Lodhi Road, New Delhi–110 003, India Ph. as regulated. The reporting of ADRs through periodic safety update reports is a regulatory requirement in many Mar 15, 2018 · The review focuses on regulation concerned to the registration procedures import of a new medical device in India with latest amendments in the regulation concerned. New Medical Device Rules, 2017 have been published by Government of India via Gazette Notification GSR 78(E) on 31st January 2017. 2017. 2 billion and is expected to reach $50 billion by 2025. • The import, manufacturing, distribution and sale of medical Medical devices 1. IVD . To register a Medical Device in India, any non-local company must appoint a Local Agent or Manufacturer to interface with the CDSCO to ensure regulatory compliance. (i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and May 23, 2018 · Safe, effective, and of high-quality medical devices are necessary for a well-functioning healthcare system. the medical device is intended according to the specifications of its product owner as stated on any or all of the following: (i) the label of the medical device; (ii) the instructions for use of the medical device; (iii)the promotional materials in relation to the medical device. India’s New Medical Device Rules: Impact and Outlook for Medical Device Industry. Manufacturing A Notified Medical Device in India 12 IV. Now all the medical devices need to be reassessed for compliance and certification. Software as a Medical Device - The term "Software as a Medical Device" (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device a. What is the regulatory environment for medical devices in India as per 'New Medical Devices Rules'? The Ministry of Health and Family Welfare on Thursday notified Medical Devices Rules, 2017, which are in conformity with Global Harmonisation Task Force (GHTF) framework. Here is the direct link to MDR English version HTML with TOC Regulation (EU) 2017/745 of the European Parliament and of […] 2. By 2025, The market for medical devices worldwide is anticipated to be worth $797 Oct 6, 2017 · Presently in India regulatory body CDSCO is governing regulation for regulation of devices which with time, amendment introducing in the law will provide safety assurance to public health. QMS . India's medical device regulatory approval process Mar 15, 2018 · The review focuses on regulation concerned to the registration procedures import of a new medical device in India with latest amendments in the regulation concerned. Global Medical Device Nomenclature. in vitro diagnostic medical device. Future of Medical Device Industry in India. Jun 16, 2019 · PDF | Medical Device (MD) is one of the fastest growing sector and so are the associated regulations. Discover the world's research Jan 31, 2024 · Device Advice. About Medical Devices. In order to market any medical device, marketing authorization from Regulatory authority is required. Medical devices are products or equipment intended for a medical purpose. These rules are harmonised with the international regulatory practices and provide comprehensive legislation for the regulation of Medical Devices fostering Make in India as well. 09 KB) 4 : National Medical Device Policy 2023 : Gazette Notification dated 03. The rules have come into effect from 1 January 2018. SaMD is a medical device and includes in-vitro diagnostic (IVD) medical device. In Biotech Consortium India Limited Jul 12, 2022 · Materiovigilance Programme of India. It is currently valued at $5. Clinical Investigation/Clinical Performance Evaluation 14 VII. 16 These directives have been replaced by the medical device regulation (EU Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing. Feb 21, 2020 · Summary: The Indian law that regulates quality and safety of medical devices has been amended and it will now apply to all medical devices, effective April 1, 2020. 724) published on October 17, 2017. Taking into account the above-mentioned criteria given in the Medical Devices Rules of 2017, CDSCO created a list of more than eighteen hundred medical devices and distributed them into 24 categories. Medical device is an instrument which is applied for diagnosis, therapy, or alleviation of diseases in human beings or animals. BALAMURALIDHARA V Asst . Conclusions: In India What's New Notice regarding Guidance for approval Covid-19 vaccine in India for restricted use in emergency situation which are already approved for restricted use by US FDA EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency use listing 15th April,2021 DCGI Message 202101 Jan 2021 For Medical devices which are under voluntary registrations, the file number generated is the Indian healthcare sector is a fast-growing industry which is expected to reach $280 billion by 2025. 1 The medical devices sector in India is an essential and integral constituent of the Indian Aug 19, 2020 · PDF | On Aug 19, 2020, Sella Senthil M and others published Advancements in Regulatory Framework For Medical Device Regulations In India | Find, read and cite all the research you need on ResearchGate Apr 26, 2023 · 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. With the publication of III. 57min) Medical Device Regulation – HPRA Presentation 15/09/2021 (PDF, size 1. , the EU, and other countries can ease the regulatory approval process by India’s Central Licensing Approval Authority (CLAA). No medical device regulations existed in India prior to 2005, but authorities overhauled the medical device regulatory process in 2017 with the publication of the Medical Device Rules. 01. A common framework for medical device regulations is a May 3, 2023 · Export Promotion Council for Medical Devices : Download (394. Considering their growing importance in the country, a clear understanding of the regulatory framework is needed to address any challenges related to their implementation. Regulation of Medical Devices. Up until 26 May 2021, refurbished medical devices were regulated similarly to new medical devices by the medical device directives 93/42/EEC 14, 90/385/ EEC15 and 98/79/EC. In India, at present only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules made thereunder in 1945. Internet using official web page 2. Professor- Regulatory Affairs Group Dept. International Medical Device Regulators Forum. com For Importer Medical Devices Regulation in United States of America, European Union and India: A Comparative Study Rohin Sethi*, Prof. By implementing a pathway for Regulation, the world’s second most populous country has paved way for improved quality in healthcare. To fulfill this gap, Central Drug Standard Control Organization released Indian Medical Device Rules, 2017, which are the new regulations for medical devices in India. In June 2005, CDSCO in India produced Medical Device guidelines and in Jan 2017, MOH notified through GSR. Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling and reporting requirements. , provided an overview of European device regulations and discussed some of the key procedures in Japan, China, and India and how they differ from current operations in the United States. Information Briefing Medical Device Regulations (vimeo video, length 1hr. If you prefer the HTML with TOC version just look into the HMTL column ans select the version for your native language. (ii) Family a. Literature search resources Mar 2, 2019 · PDF | On Mar 2, 2019, Sandeep Lahiry and others published Medical device regulation in India: What dermatologists need to know | Find, read and cite all the research you need on ResearchGate the devices manufactured by the manufacturer and meant for import into India is required to be made by the manufacturer or importer or his agent in India, in Form 40 and in form and manner as under Rule 24A of the Drugs and Cosmetics Rules. R 78(E) dated 31. There has been an upsurge in the number, diversity, and intricacy of medical devices in last two decades. A. Pharm , Pharma Regulatory Affairs, JSSCP, Mysore. The definition of Notified medical devices should include the below text, “Providedthat the Medical Device is already being marketed in India, clinical investigations or evaluations May 3, 2023 · भारत सरकार Government of india; National Medical Device Policy 2023 : Gazette Notification dated 03. 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. 2023 (2 MB) 5 : Strategy Document on National Medical Devices Policy, 2023 : Strategy Document on National Medical Devices Policy, 2023 (7. In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended. • The registration process for medical devices in India remains fluid, but regulators are taking steps to develop a more formalized oversight policy. Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945; Medical Devices Rules, 2017; Medical Devices (Amendment) Rules, 2020; Medical Overview of medical device regulations in India. IS a collection of medical devices and each medical device,­ (i) is from same license holder; (ii) is of same risk classification class; (iii) Software as Medical Device (SaMD) is increasingly being adopted to significantly improve healthcare. Labeling 15 IX. 7 This Bill proposed creating a Medical Device Regulatory Authority of India and introducing a risk-based classification of medical devices. A draft notification [Medical Devices Rules, 2016] dated 17 th October 2016, has been issued for medical devices by the Ministry of Health and Family Welfare, Department of Health and Family Welfare, Government of India [GSR 983 (E)]. 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. TGA in Australia, MHRA in UK, ENVISA in Brazil, CDSCO in India etc. A medical device family . 1. S. Indian medical device sector is emerging with innovative and indigenous solutions. Manufacture/Import of an Investigational Medical Device and New in vitro Diagnostic Medical Device 13 VI. Medical and in vitro diagnostic (IVD) device manufacturers need to obtain approval from Agência Nacional de Vigilância Sanitária (ANVISA) prior to selling their products in Brazil. The policy endeavours to facilitate an orderly growth of the sector and in turn, achieve the Overview of Brazil ANVISA medical device regulations. product meets the “medical device” definition and is thus regulated by health authorities. of pharmaceutics JSSCP, Mysore Presented by: SURAJ P. May 1, 2016 · The new regulation (EU) 2017/745 on Medical Devices (MDR) is now applicable from May 26 2021 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 will take effect from May 2022. quality management system. Definitions (i) "Analytical performance" means the ability of an IV D medical device to detect or measure a particular analyte„ (ii) "Clinical data" means safety or performance information that is generated from the clinical use of a medical device. 66 MB) 6 Jun 21, 2017 · The analysis of this paper will focus on the issues inherent with the current process of discovery, the updating and patching of vulnerable software processes, manufacturer responsibilities, and potential interim solutions for healthcare providers that can help identify risks as the authors wait for changes to the current FDA processes and provide steps that healthcare providers can take in Mar 30, 2015 · 1. The process of gaining Dec 3, 2021 · Request PDF | Comparison of Medical Device Regulations in India, Japan and South Korea | Increased health awareness, a growing middle class, and government health efforts are projected to propel It has also introduced various fiscal measures to promote research, development, manufacturing and import of medical devices in India. The objective of this study is to compare regulatory guidelines of SaMD in India in comparison to USA, EU, and Australia Studies with medical devices . 2022, as per G. CDSCO, after recognizing the requirement to establish more stringent and specific regulations for separating medical device from drug, refurbish the regulatory framework for medical device by passing the Medical Device rules 2017. However, India does not … The MDR 2017 are effective from 01. Mar 6, 2023 · PDF | The usage of medical device is on the rise due to the rise in incidence rate of chronic diseases, irregular health check-ups, and sedentary | Find, read and cite all the research you need Dec 21, 2015 · au/pdf/devices-argmd-01 The central licensing authority for medical devices in India is the Drug Controller General of India (DCGI). The Indian medical devices sector is on a growth track and has an enormous potential to become self-reliant and to contribute towards the goal of Welfare, Government of India Central Drugs Standard Control Organization (Medical Devices and Diagnostic Division) Medical Devices (MD) Frequently Asked Questions on Medical Device Rule, 2017 Doc No. It is significantly behind developed economies like the USA (USD 340). the CDSCO works on developing the standards and regulations for drugs, diagnosis, and devices; updating regulations by amending acts and rules; and regulating the marketing authorization of new drugs to bring safe and effective drugs in market (Jaysheel, 2010). Software must have an intended use that fulfills the definition of a medical device in order to be considered as a medical device. Cosmetics Act of 1940. Mar 1, 2019 · PDF | On Mar 1, 2019, Sandeep Lahiry and others published Medical device regulation in India: What dermatologists need to know | Find, read and cite all the research you need on ResearchGate 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. •The medical device sector in India needs to be empowered through private-public partnerships among the Indian Download from the link below the MDR in the main European languages. 2018 to regulate the Clinical Investigation, Manufacture, Import, Sale and Distribution of the medical devices in the country. f. Key aspects include risk-based classification of devices, provisions for notified bodies to certify quality management systems and essential safety and performance standards, and separate regulation of clinical investigations of new devices in line with Medical devices and diagnostics cater an integral component of the health care system with a mandate of 'access and equity'. IMDRF . 78 (E) the separate guideline for “Medical Devices Rules, 2017” which came into force from 1st Jan 2018. Medical Device, defined • Instrument, apparatus, machine, implant, in vitro reagent, including component, part, or accessory • Diagnoses, cures, mitigates, treats Guidance Document on Medical Devices MoHFW, Government of India 3. 648(E), February 11, 2020, Medical Device Definition; Medical Device Rules, 2017; ISO 13485:2016 - Quality Management Systems; ISO 14971:2019 - Application of Risk Management to Medical Devices What's New Vacancy for post of Director in RDTL Chandigarh Vacancy for Deputy Director in RDTL Guwahati Vacancy for Senior Assistant (Admn) in CDSCO Number of Cough syrup sample for Export at Different Laboratories for testing Regulation of all Class A & B Medical Devices under Licensing regime, w. The history of drug regulation in India goes back to the British Rule when most Jan 20, 2021 · The Science and Technology Ministry released a draft of the "Medical Devices Regulation Bill, 2006", for comments. The Medical Device Rules, 2017 have been implemented w. However, India has the potentia to be one of the top 20 globa med'cal device markets in a quick span of time. 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. In Trends and challenges in medical device regulation . In the wake of the need to regulate the safety surveillance of medical devices in India, under the umbrella scheme of the Pharmacovigilance Programme of India (PvPI), the Ministry of Health and Family Welfare has authorized the MvPI, a system for monitoring the safety of medical equipment affiliated from the Government of India in 2013. The Medical Devices Rules, 2017 provide comprehensive regulation of medical devices in India to foster the Make in India initiative. Overview of Regulatory Guidelines 3. each medical device supplied individually must be licensed as a single medical device. NRA . 2023 (2 MB) Featured. S 1st M. India Medical Device Conclusion 1. Q5. ISO . Regulation of these devices has also advanced due to the requirement for a steady regulatory Guidance Document on Medical Devices MoHFW, Government of India . : CDSCO/FAQ/MD/01/2018 CENTRAL DRUGS STANDARD CONTROL ORGANIZATION DIRECTORATE GENERAL OF HEALTH SERVICES MINISTRY OF HEALTH & FAMILY WELFARE GOVT. May 22, 2023 · The story so far: On April 26, the Union Cabinet approved the National Medical Devices Policy, 2023. Seminar on Strengthening Medical Device Licence Holders on Post-Market Safety Surveillance Practices in India and Medical Device Stakeholders Consultation Meeting PGIMER Chandigarh on 3rd September 2024: 2024-Jul-26: 1515 KB: 2: Applicant User Manual For Form MD-41: 2022-Nov-18: 1335 KB: 3: FSCA Form: 2019-Apr-09: 404KB: 4: Medical Device Aug 9, 2022 · The Software as a Medical Device (SaMD) to be marketed in India is subjected to and must comply with the following regulations: S. Biotech Consortium India Limited Jul 12, 2022 · Materiovigilance Programme of India. (2017) Asia Regulatory Roundup: India Adopts New Medical Device Regulations. Medical Devices : Current Regulations ØMedical Devices are notified as DRUGS under Drugs & Cosmetics Act. Medical devices regulations primarily focused on the quality and safety control to ensure the highest standards assurance of a medical device. Medical Device & Diagnostics. f 01. Apr 28, 2023 · Read Our Blog: Procedure for Manufacturing of Class C and Class D Medical Devices in India. 102(E) dt 11. Importing A Notified Medical Device into India 12 V. India Medical Device Regulations. national regulatory authority. India While the CDSCO does have a robust classification catalog for medical devices & IVDs, it does not Oct 17, 2017 · The Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health & Family Welfare (MoHFW), Government of India issued a draft of Medical Devices Rules, 2017 through a gazette notification (No. Setting up a framework aids Local Device Manufacturing 2. David Jefferys, a medical device expert and senior vice president for global regulatory, health-care policy, and corporate affairs at Eisai Europe, Ltd. Medical Device Regulations In India 3rdevaluationseminar Facilitated by DR. : +91–11–24682177–80, Fax: +91–11–24682173–74 Jan 9, 2017 · Medical Device Rules 2017, India: Medical Devices Classifications / Medical Device Regulations for Regulatory Approval and Registration +91 7672005050 contact@cliniexperts. This current under – penetration of medical devices in India represents a sizeable growth opportunity. Jan 1, 2012 · Request PDF | Regulatory guidelines for medical devices in India: An overview | The objective of the present study offers an overview of regulatory guidelines for medical devices in India. R. They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. Mar 3, 2023 · Indian healthcare sector is a fast-growing industry which is expected to reach $280 billion by 2025. Prior to the amendment, only 37 categories of medical devices were regulated or were notified to be regulated in near future in India. Medical Device Rules, 2017. Harvinder Popli and Sunit Sethi Department of Drug Regulatory Affais, Center for Pharmaceutics, Delhi Pharmaceutical Science and Research University, Delhi, India However, the per capita spend on medical devices in India is the lowest among BRIC countries at USD 3(USD 7 in China, USD 21 in Brazil and USD 42 in Russia). This review highlights the recent progress in Indian medical device regulation with the dawn of Medical Device Rules 2017 in the light of Drugs and Cosmetics Act 1940 and Rules 1945. Increased health awareness, a growing middle class, and government health efforts are projected to propel India's medical equipment market forward in the next years. Medical Oct 1, 2023 · In May 2021, the new Medical Device Regulation in the EU came into force. From 1989 to 2005 only 14 products were notified and regulated as Medical Device. It is believed that national medical device regulation harmonization is required to lower regulatory barriers and offer timely access to safe and effective medical equipment [Citation 47, Citation 48]. Before manufacturers of medical and in vitro diagnostic (IVD) devices can sell in India, they need to engage an importer to register their products with the Central Drugs Standard Control Organization (CDSCO), which will issue an import license. Already existing devices in India which have proof of usability on or before 31 December 2017 should be. Product Standards 15 VIII. International Electrotechnical Commission. It Indian medical device regulation bill • India had no regulations for medical devices in place prior to 2005. The immediate consequence of South Korea is one of the largest health-care markets in the Asia-Pacific region and the South Korean Ministry of Food and Drug Safety launched UDI (Unique Device Identification System) operations in 2018. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Directorate General of Health Services, Government of India FDA Bhavan, ITO, Kotla Road, New Delhi -110002 Ministry of Health & Family Welfare, Government of India has released the Medical Device Rules, 2017, effective from 1st January, 2018 for regulating Medical Devices being used in the country. medical device is safe and performs as intended by the manufacturer and therefore conforms to the essential principles of safety and performance for medical devices; (q) “controlling officer” means the officer designated under rule 10; (r) “custom made medical device” means a medical device made specifically Contact Info. Medical devices market in India is one of the top 20 medical device markets in the world. Medical Device Innovation in India Medical device innovation in India •“Innovation in India” can help drive : •Make in India •Enhance Quality •Reduction in Cost for Domestic and developed market. 01. Latika Vats, India CoE. As India is playing a major role in marketing of these devices in Asia, and beyond, Jul 12, 2021 · In India, there were no specific medical device regulations and devices were regulated under the Drugs and Cosmetics Act, 1940. List of Medical Device Categories and Classes. Mar 5, 2021 · Policies, strategies, and action plans for health technologies, specifically for medical devices, are required in any national health plan. May 1, 2019 · More recently, the government of India has been considering developing a separate ministry that governs the medical device regulation [20]. 23 MB, 34 pages) Medical Device Regulations Update – HSE Presentation 15/09/2021 (PDF, size 500 KB, 18 pages) MDR implementation 2021 Comparative Overview of Medical Device Regulatory Systems. Before implementing the Medical Device rules of the Medical Device Rules, ‘notified medical devices’ were May 26, 2021 · The primary care medical practitioners as well as common public must be made aware of the importance and benefits of reporting adverse drug reactions (ADRs). In India, pre-market reviews of medical devices are limited to certain categories of medical devices, and prior approval in the U. International Organization for Standardization. 5%. Discover the world's research In India, there were no specific medical device regulations and devices were regulated under the Drugs and Cosmetics Act, 1940. b. It recognized certain shortcomings of housing devices under the definition of 'drugs' and 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. 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