Singapore’s Health Sciences Authority (HSA) has published a guidance document detailing the classification rules for In Vitro Diagnostic (IVD) medical devices. As per the general rule, Regulatory controls should be proportional to the level of risk associated with an IVD medical device.
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May 16, 2022 Medical Devices -
May 5, 2022 Medical DevicesEurope is the busiest region with evolving Regulatory landscape, as Brexit compliance, application of the EU MDR, transition to UKCA marking, and upcoming IVDR deadline take the front seat. All these dynamics have kept the Regulatory professionals on their toes.
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March 31, 2022 Medical DevicesThe European Notified Bodies (NBs) have published a new position paper to address the concerns of MDR/IVDR designated NBs. It will be effective from May 26, 2022 to May 26, 2024. The MDR/IVDR regulations aim to improve patient safety by strengthening the requirements for manufacturers and NBs.
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March 16, 2022 Medical DevicesThe Swiss Mutual Recognition Agreement (MRA) for medical devices between the EU and Switzerland has lapsed on May 26, 2021, and the negotiations between Switzerland and the EU have concluded without any concurrence on Institutional Agreement (InstA).
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February 22, 2022 Medical DevicesMedical devices need an efficient, effective, and readily available user manual. Over time, paper Instructions for Use (IFU) have been the norm in the medical device industry. However, with the advent of electronic technologies, the paper IFU has been replaced by electronic IFU (eIFU).
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February 21, 2022 Medical DevicesThere are various Economic Operators (EOs) who play a vital role in a device supply chain while delivering them to the point of use. Given the importance of each role, the Swiss Medical Device Ordinance (MedDO; SR 812.213) has set out the roles and responsibilities for each of these EOs.
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February 14, 2022 Medical DevicesWith technological advancements, the adoption of wireless medical devices for patients and healthcare management is growing at a fast pace. It is anticipated that four (04) out of ten (10) medical devices installation will be wireless or portable by 2031, and the wireless portable medical device market is expected to reach USD 33 billion.
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January 27, 2022 Medical DevicesThe Medical Device industry is booming, with new technologies emerging every other day. The year 2021, like 2020, has experienced continued disruption owing to subsequent waves of the COVID-19 pandemic.
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Thanks to the rapid development of vaccines and quick vaccinations in major parts of the world, there seem positive developments in all the business sectors towards the growth. However, the threat is persisting in terms of new waves and new variants of COVID. Let us hope we soon get over this and see the brighter side of the business.
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It is apparent that COVID-19 has permanently changed the ways of business operations for many industries across the globe. In fact, it has subtly given a renewed purpose to industries to evolve and advance in terms of tech-enabled and automated workflows.