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 15, 2021 Chemicals, Regulatory Affairs, Regulatory LabelingMost of us have come across the terms 'Disinfectants' and 'Sanitizers' during COVID-19. Both the products fall under antimicrobial pesticides. While disinfectants and sanitizers are commonly referred as same, the major difference between them is that the disinfectants kill the microbes, bacteria and virus on the surface whereas the sanitizers reduce their numbers.
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July 15, 2021 Food and Food Supplements, Regulatory AffairsA growing business is directly proportional to the potentiality of the market.
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July 14, 2021 Chemicals, Regulatory Artwork Services, Regulatory Affairs, Regulatory LabelingThe chemicals industry plays a pivotal role in producing petrochemicals, polymers, basic inorganics, specialities and consumer chemicals in Europe. European Chemicals Agency (ECHA) implements the EU’s chemicals legislation to protect health, safety and the environment.
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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 13, 2021 Medical DevicesMexico is considered as the second largest market for medical devices in Latin America. In Mexico, the Federal Commission for the Protection against Sanitary Risk (COFEPRIS) from the Secretariat of Health, regulates the Medical Device registrations and related services.
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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.