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  Medical Product Alert N°3/2022: Falsified Intratect (Human normal immunoglobulin)

Medical Product Alert N°3/2022: Falsified Intratect (Human normal immunoglobulin) Global Regions WHO Regional websites Africa Americas South-East Asia Europe Eastern Mediterranean Western Pacific When autocomplete results are available use up and down arrows to review and enter to select. (...) Advice to regulatory authorities and the public WHO requests increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these falsified products. All medical products must be approved and obtained from authorized/licensed suppliers. (...) If you are in possession of these falsified products, please do not use them. If you have used these products, or you suffered an adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional and report the incident to the National Regulatory Authority or National Pharmacovigilance Centre.

Score: 834556.4 - https://www.who.int/news/item/...ct-human-normal-immunoglobulin

  22 December 2020 Pag

22 December 2020 Page: 1/12 Original: English TRADE IN MEDICAL GOODS IN THE CONTEXT OF TACKLING COVID-19: DEVELOPMENTS IN THE FIRST HALF OF 2020 INFORMATION NOTE1 KEY POINTS: • While total world trade declined by 14 per cent in the first half of 2020 compared to the same time period in 2019, imports and exports of medical goods increased by 16 per cent, reaching US$ 1,139 billion in value.2 • Trade played a critical role in meeting skyrocketing demand for products considered critical in the COVID-19 pandemic, with global trade in these products growing by 29 per cent. • Total imports of face protection products in the first half of 2020 increased by 90 per cent compared to the same period last year. (...) Table 1: Trade in medical products (first half of each year indicated), 2018-20 Product category Value (US$ million) Growth rate (%) 2018 2019 2020 2019/18 2020/19 EXPORTS All medical products 480,596 489,291 564,405 1.8 15.4 Medical equipment 66,356 67,706 70,516 2.0 4.2 Respirators 3,573 3,870 6,055 8.3 56.5 Medical supplies 83,579 85,425 94,062 2.2 10.1 Medicine 261,450 267,383 298,665 2.3 11.7 Personal protective products 69,211 68,776 101,161 -0.6 47.1 Face masks 37,908 37,980 70,022 0.2 84.4 Hand sanitizers 18,792 18,056 17,164 -3.9 -4.9 Hand soaps 10,884 11,076 12,189 1.8 10.0 Other protective covers 1,626 1,665 1,786 2.4 7.3 COVID-19-critical products 146,908 148,600 189,144 1.2 27.3 IMPORTS All medical products 480,148 494,566 574,632 3.0 16.2 Medical equipment 66,146 68,017 72,637 2.8 6.8 Respirators 3,787 4,104 6,479 8.4 57.9 Medical supplies 81,675 83,689 91,214 2.5 9.0 Medicine 265,333 275,274 306,996 3.7 11.5 Personal protective products 66,995 67,586 103,784 0.9 53.6 Face masks 38,109 38,606 73,515 1.3 90.4 Hand sanitizers 17,281 17,059 16,879 -1.3 -1.1 Hand soaps 10,140 10,385 11,593 2.4 11.6 Other protective covers 1,465 1,536 1,798 4.9 17.0 COVID-19-critical products 142,977 146,611 191,725 2.5 30.8 Trade in all categories of medical products increased in the first half of 2020. (...) Trade in respirators also grew rapidly, by 57 per cent, although the value of this 5 Critical medical products include: disinfectants/ sterilization products; face masks; gloves; hand soap and hand sanitizer; patient monitors and pulse oximeters; protective spectacles and visors; sterilizers; syringes; thermometers; ultrasonic scanning apparatus; ventilators, oxygen masks; X-ray equipment; and other devices such as computer tomography apparatus. 2.4 2.4 2.3 3.0 0.1 15.8 5.5 9.6 11.6 50.3 0.0 10.0 20.0 30.0 40.0 50.0 60.0 All Medical equipment Medical Supplies Medicine Personal Protective Products Ye ar o n y ea r p er ce n ta ge c h an ge 1st half of 2019 compared to 2018 1st half of 2020 compared to 2019 Medical equipment, 14% Medical Supplies, 17% Medicine, 55% Face Masks, 7.8% Hand Sanitizers, 3.6% Hand Soaps, 2.2% Other Protective Covers, 0.3% Personal Protective Products, 14% 2019 - US$ 983 billion Medical equipment, 13% Medical Supplies, 16% Medicine, 53% Face Masks, 12.6% Hand Sanitizers, 3.0% Hand Soaps, 2.1% Other Protective Covers, 0.3% Personal Protective Products, 18% 2020 - US$ 1,139 billion 4 trade amounted to only US$ 13 billion, equivalent to just over 1 per cent of trade in all medical goods.

Score: 833281.8 - https://www.wto.org/english/tr...9_e/medical_goods_update_e.pdf

  Medical Product Alert N°2/2019: Falsified ICLUSIG traded globally

Medical Product Alert N°2/2019: Falsified ICLUSIG traded globally Global Regions WHO Regional websites Africa Americas South-East Asia Europe Eastern Mediterranean Western Pacific When autocomplete results are available use up and down arrows to review and enter to select. (...) WHO requests increased vigilance within the supply chains of countries likely to be affected by these falsified products. Increased vigilance should include hospitals, clinics, health centres, wholesalers, distributors, pharmacies and any other suppliers of medical products. (...) All medical products must be obtained from authentic and reliable sources.

Score: 832883.8 - https://www.who.int/news/item/...ert-n-2-2019-(english-version)

  Medical Product Alert N° 1/2020: Falsified antimalarials displaying an outdated WHO Essential Drugs

Outdated WHO Essential Drugs Programme logo  Photographs of confirmed falsified Quinine Sulphate 300mg tablets subject of Medical Product Alert N°1/2020 1.        Falsified Quinine Sulphate Tablets B.P 300mg identified in Chad (Batch 44680) 2. Falsified Quinine Sulphate Tablets B.P 300mg identified in Nigeria and Cameroon (Batch 44680) WHO requests increased vigilance within the supply chains of countries likely to be affected by these falsified products. Increased vigilance should include hospitals, clinics, health centres, wholesalers, distributors, pharmacies and any other suppliers of medical products. (...) All medical products must be obtained from authentic and reliable sources.

Score: 832660.45 - https://www.who.int/news/item/...alert-n-1-2020-english-version

  1st World Conference on Access to Medical Products and International Laws for Trade and Health

Select language Select language English South-East Asia India Home Health topics Our work News Emergencies About us Home / News / Detail / 1st World Conference on Access to Medical Products and International Laws for Trade and Health 1st World Conference on Access to Medical Products and International Laws for Trade and Health 22 November 2017 Highlights To enable a holistic view on access to medicines, including all medical products: medicines, vaccines, devices and diagnostics, the Ministry of Health & Family Welfare, Government of India and Indian Society of International Law with the support of WHO is organizing the “1st World Conference on Access to Medical Products and International Laws for Trade and Health in the Context of the 2030 Agenda for Sustainable Development” from 21-23 November 2017 at New Delhi. (...) Experts at this closed forum will deliberate on various themes of access to medical products, innovation and research & development and Intellectual Property Rights to provide guidance and specific recommendations leading to possible policy interventions by the governments and other stakeholders. (...) For more Information, please visit: http://www.worldsdg2030.org/, the official website of ‘1st World Conference on Access to Medical Products and International Laws for Trade and Health, in the context of 2030 Agenda for Sustainable Development’, 21-23 November 2017, New Delhi, India.

Score: 831734.8 - https://www.who.int/india/news...onal-laws-for-trade-and-health

  30 June 2021 Page: 1

This increase of 1.3 percentage points in the share of world trade is for a relatively small group of products (92 Harmonized System (HS) subheadings). Chart 1: Yearly trade growth in medical goods, by product group, 2019 and 2020 Source: WTO Secretariat Table 1: Trade in medical products, 2018-20 Product category Value (US$ million) Annual change (%) 2018 2019 2020 2019 2020 EXPORTS All medical products 957,679 999,123 1,159,674 4.3 16.1 Medical equipment 134,517 140,894 150,985 4.7 7.2 Ventilators 7,373 8,037 13,944 9.0 73.5 Medical supplies 164,968 172,511 204,391 4.6 18.5 Test kits & diagnostic reagents 6 27,274 28,159 39,249 3.2 39.4 Medicine 520,175 546,253 603,226 5.0 10.4 Personal protective products 138,019 139,465 201,071 1.0 44.2 Face masks 75,505 77,159 136,257 2.2 76.6 3 Data sources for all figures cited in this information note are the Trade Data Monitor, the WTO Integrated Database and the WTO Data Portal. See the annex for a full list of medical products and their HS subheadings. 4 WTO Secretariat calculations based on data from the WTO Data Portal. 5 The list of medical goods and categorization can be consulted in Annex 1 and can also be found in the earliest version of this information note, "Trade in medical goods in the context of tackling COVID-19", issued on 3 April 2020. 6 HS subheading 3822.00 only. 4.7 4.6 4.3 5.7 1.5 16.3 8.4 18.8 9.8 47.2 0 5 10 15 20 25 30 35 40 45 50 All medical products Medical equipment Medical supplies Medicine Personal protective products G ro w th R at e (% ) 2019 2020 https://www.tradedatamonitor.com/ https://www.wto.org/english/tratop_e/tariffs_e/idb_e.htm https://www.wto.org/english/tratop_e/tariffs_e/idb_e.htm https://data.wto.org/ http://data.wto.org/ https://www.wto.org/english/news_e/news20_e/rese_03apr20_e.pdf 3 Product category Value (US$ million) Annual change (%) 2018 2019 2020 2019 2020 Hand sanitizers 37,068 35,941 35,062 -3.0 -2.4 Hand soaps 22,040 22,914 25,923 4.0 13.1 Other protective covers 3,406 3,452 3,830 1.3 10.9 COVID-19-critical products 294,717 303,915 394,824 3.1 29.9 IMPORTS All medical products 966,146 1,015,99 2 1,183,170 5.2 16.5 Medical equipment 135,849 141,954 155,545 4.5 9.6 Ventilators 7,872 8,325 14,919 5.8 79.2 Medical supplies 162,613 169,279 201,548 4.1 19.1 Test kits & diagnostic reagents 6 28,504 28,540 41,160 0.1 44.2 Medicine 533,285 567,733 620,049 6.5 9.2 Personal protective products 134,400 137,027 206,027 2.0 50.4 Face masks 76,065 78,156 141,409 2.7 80.9 Hand sanitizers 34,674 34,060 35,581 -1.8 4.5 Hand soaps 20,627 21,650 24,915 5.0 15.1 Other protective covers 3,033 3,162 4,123 4.2 30.4 COVID-19-critical products 288,850 299,858 398,996 3.8 33.1 Source: WTO Secretariat All medical product groups showed significant increases in trade in 2020 (Chart 2). (...) Diagnostic reagents and test kits, used to determine the incidence rate of COVID-19, accounted for around 20 per cent of trade in medical supplies. These products, classified under HS subheading 3822.00,7 represented 3.4 per cent of trade of all medical products.

Score: 831403 - https://www.wto.org/english/tr...dical_goods_update_jun21_e.pdf

  Medical Product Alert N°5/2019: Falsified Meningitis vaccines

Medical Product Alert N°5/2019: Falsified Meningitis vaccines Global Regions WHO Regional websites Africa Americas South-East Asia Europe Eastern Mediterranean Western Pacific When autocomplete results are available use up and down arrows to review and enter to select. (...) On 15 March 2019, the Ministry of Public Health in Niger issued a call for vigilance regarding the circulation of falsified Mencevax ACWY vaccines. This WHO medical product alert provides the details of those products which have been confirmed as falsified to date. (...) Samples are being sent for laboratory analysis to determine their contents and better assess the risk to public health. This medical product alert n°5/2019 will subsequently be updated and posted on the WHO website once laboratory results are known.

Score: 831219.9 - https://www.who.int/news/item/...ert-n-5-2019-(english-version)

  News

Select language Select language English South-East Asia India Home Health topics Our work News Emergencies About us Home / News / Detail 16 April 2018 Highlights Andhra Pradesh CM launches WHO report on the state’s free diagnostics scheme 25 July 2018 Highlights India set to launch National Viral Hepatitis Control Programme 27 July 2018 Highlights Health gains from the Swachh Bharat initiative 31 July 2018 Highlights Workshop on implementation of TB-Tobacco collaborative activities 10 October 2018 Highlights 2nd World Conference on Access to Medical Products - Achieving the SDGs 2030 10 October 2018 Highlights 2nd World Conference on Access to Medical Products: Achieving the SDGs 2030 18 October 2018 Highlights 2nd Road Safety Sensitization Workshop for Journalists 5 October 2018 Highlights Union Health Minister inaugurates ‘2nd World Conference on Access to Medical Products: Achieving the SDGs 2030’ 19 February 2019 Highlights 4th International Conference on Pharmaceuticals and Medical Industry held in Bengaluru 22 August 2019 Highlights 3rd Annual Regulators Conclave for Central and State Regulatory Authorities in India 30 June 2019 Highlights MoHFW launches new real time Health Management Information System online portal in five states 2 June 2019 Highlights WHO Representative to India meets Union Health Minister 12 December 2018 Highlights India hosts 4th WHO Global Forum on Medical Devices 10 October 2018 Highlights Statement by WHO and UNICEF Polio vaccination programme 22 March 2016 Statement Large tobacco pack warnings save lives « 11 12 (current) 16 April 2018 Highlights Andhra Pradesh CM launches WHO report on the state’s free diagnostics scheme 25 July 2018 Highlights India set to launch National Viral Hepatitis Control Programme 27 July 2018 Highlights Health gains from the Swachh Bharat initiative 31 July 2018 Highlights Workshop on implementation of TB-Tobacco collaborative activities 10 October 2018 Highlights 2nd World Conference on Access to Medical Products - Achieving the SDGs 2030 10 October 2018 Highlights 2nd World Conference on Access to Medical Products: Achieving the SDGs 2030 18 October 2018 Highlights 2nd Road Safety Sensitization Workshop for Journalists 5 October 2018 Highlights Union Health Minister inaugurates ‘2nd World Conference on Access to Medical Products: Achieving the SDGs 2030’ 19 February 2019 Highlights 4th International Conference on Pharmaceuticals and Medical Industry held in Bengaluru 22 August 2019 Highlights 3rd Annual Regulators Conclave for Central and State Regulatory Authorities in India 30 June 2019 Highlights MoHFW launches new real time Health Management Information System online portal in five states 2 June 2019 Highlights WHO Representative to India meets Union Health Minister 12 December 2018 Highlights India hosts 4th WHO Global Forum on Medical Devices 10 October 2018 Highlights Statement by WHO and UNICEF Polio vaccination programme 22 March 2016 Statement Large tobacco pack warnings save lives « 11 12 (current) 16 April 2018 Highlights Andhra Pradesh CM launches WHO report on the state’s free diagnostics scheme 25 July 2018 Highlights India set to launch National Viral Hepatitis Control Programme 27 July 2018 Highlights Health gains from the Swachh Bharat initiative 31 July 2018 Highlights Workshop on implementation of TB-Tobacco collaborative activities 10 October 2018 Highlights 2nd World Conference on Access to Medical Products - Achieving the SDGs 2030 10 October 2018 Highlights 2nd World Conference on Access to Medical Products: Achieving the SDGs 2030 18 October 2018 Highlights 2nd Road Safety Sensitization Workshop for Journalists 5 October 2018 Highlights Union Health Minister inaugurates ‘2nd World Conference on Access to Medical Products: Achieving the SDGs 2030’ 19 February 2019 Highlights 4th International Conference on Pharmaceuticals and Medical Industry held in Bengaluru 22 August 2019 Highlights 3rd Annual Regulators Conclave for Central and State Regulatory Authorities in India 30 June 2019 Highlights MoHFW launches new real time Health Management Information System online portal in five states 2 June 2019 Highlights WHO Representative to India meets Union Health Minister 12 December 2018 Highlights India hosts 4th WHO Global Forum on Medical Devices 10 October 2018 Highlights Statement by WHO and UNICEF Polio vaccination programme 22 March 2016 Statement Large tobacco pack warnings save lives « 11 12 (current) Quick links Media centre Publications and information resources Photo gallery WHO Representative India Regional links Publications Campaigns Help Contact us Scam alert Privacy Integrity Hotline Employment Announcements Cyber security Privacy legal notice © 2022 WHO

Score: 830166.4 - https://www.who.int/india/news/detail/12

  Updated DEL02.2: Guidelines for AI based medical device: Regulatory requirements (Draft: April 2020)

Regulation plays an important role in ensuring the safety of patients and users, and in the commercialization and market acceptance of these AI based medical devices (AI-MD).Therefore, a streamlined and systematic regulatory compliance process can help to expedite the regulatory approval and to reduce the time-to-market for these products. (...) Figure 1: AI-MD Classification Criteria & Scope 1.1.1 Scope of regulation Medical device: · with enforcement of regulations · without enforcement of regulations 1.1.2 Scope of product · Software is the product ->Standalone Software · Software is embedded in product 1.1.3 Scope of application In healthcare · To improve medical outcome (e.g. to support diagnosis, treatment, prevention, monitoring and prediction of diseases and injuries) · To improve efficiency of healthcare system (e.g. streamline processes) 1.2 Guidelines: aim & objectives Aim · to help manufacturers develop AI-based products conforming to the law and bring them to market quickly and safely · to help internal and external auditors test the legal conformity of AI-based medical devices and the associated life-cycle process. Objectives The objective of this guideline is to provide target users with instructions and to provide them with a concrete checklist to · understand what the expectations of the regulatory bodies are, · to promote step-by-step implementation of safety and effectiveness of Artificial Intelligence / Machine Learning (AI/ML) Based Software as Medical Device, · to compensate for the lack of a harmonized standard (in the interim) to the greatest extent possible. 1.3 Guidelines: target user class / roles The following user classes /roles are deemed responsible for using the guidelines · Quality Assurance Auditors / Managers · Developers · Testers · Data scientists · Clinical specialists · Physicians · Product Managers · Medical Device Consultants · Regulatory specialists · Risk assessment specialists · Service and support providers 1.4 Requirements assessment model: a product lifecycle development based approach Figure 2(a): Regulatory roadmap-AI-medical device scope Figure 2(a) shows the generic as well as the AI specific aspects that need to be considered under the regulatory roadmap of medical devices.

Score: 829804.9 - https://www.itu.int/en/ITU-T/f...ocuments/all/FGAI4H-I-036.docx

  Medical Product Alert N°4/2019: Falsified oral cholera vaccines

Medical Product Alert N°4/2019: Falsified oral cholera vaccines Global Regions WHO Regional websites Africa Americas South-East Asia Europe Eastern Mediterranean Western Pacific When autocomplete results are available use up and down arrows to review and enter to select. (...) Increased vigilance should include hospitals, clinics, health centres, wholesalers, distributors, pharmacies and any other suppliers of vaccines or medical products. If you are in possession of the above products, please do not use. (...) All medical products must be obtained from authentic and reliable sources.

Score: 829743.4 - https://www.who.int/news/item/...ert-n-4-2019-(english-version)