With the growing economy and population, the demand for safe and effective healthcare facilities has increased in Sri Lanka. National Medicines Regulatory Authority (NMRA) of Sri Lanka is responsible for assuring that the medical devices imported into Sri Lanka pertain to high standards of safety, quality and efficacy.
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July 22, 2021 Medical Devices, Regulatory Affairs -
July 16, 2021 Medical DevicesBringing novel medical devices into global markets can be a daunting process for device manufacturers. As the medical device industry is highly regulated, manufacturers find it excruciating to align with the target market’s registration requirements. How to navigate the Regulatory maze of global registration requirements?
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July 13, 2021 Medical DevicesIt is well known that the mandatory deadline for European Medical Device Regulation (EU MDR) was postponed to May 26, 2021, due to abrupt onset of COVID-19.
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July 13, 2021 Medical DevicesThe medical devices undergo conformity assessment before they are included in the ARTG list to ensure that the devices comply with the essential principles required by the Therapeutic Goods Administration (TGA), Australia. Essential principles basically outline the safety and performance characteristics that any device should meet, so that it can be sold in Australia.
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July 8, 2021 Medical Devices, Regulatory AffairsThe Indian medical device industry has been recording significant growth and ranks in the top 20 markets for medical devices worldwide. It is estimated to reach USD 50 billion by 2025 from that of USD 10.36 billion in 2020.
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June 21, 2021 Medical DevicesThe recent political changes between the Switzerland and European Union (EU) have significantly impacted the Medtech industry. With more than 1400 Medtech companies, the medical devices sector accounts for 3% of Switzerland’s GDP and provides employment for > 63,000 workforce.
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June 10, 2021 Medical DevicesThe Conformity Assessment Body (CAB) carries out the conformity assessment of various stakeholders of medical device supply chain system. The Conformity Assessment Body (CAB), Malaysia carries out extensive audits and evaluates all the applicable elements set by the Medical Device Authority (MDA), Malaysia and verifies the device conformity to the relevant standards.
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June 10, 2021 Medical DevicesThe Conformity Assessment Body (CAB) plays a vital role in issuing various certifications and carrying out technical assessments required for successful registration and distribution of your medical devices and IVDs.
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May 24, 2021 Medical DevicesIt is a known fact that the European Union’s In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) will be in effect from May 26, 2022 and IVD manufacturers have to be prepared to implement the mandatory Regulatory requirements for this transition.
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May 24, 2021 Medical DevicesOver the years, with the advancements of software and digitalization, there has been a seismic shift in how medical devices are administered and delivered.