The Medical Device Coordination Group (MDCG) has recently published a joint implementation and preparedness plan for the In Vitro Diagnostic medical devices Regulation 2017/745 (IVDR). It is well known that the IVDR is expected to come into force later in May 2022.
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September 20, 2021 Medical Devices, Regulatory Affairs -
September 17, 2021 Medical Devices, Regulatory AffairsThe US FDA has published a guidance document that will help the industry and the Health Agency (HA) staff determine when a software change to a medical device requires a manufacturer to submit and obtain the FDA clearance of a new premarket notification (510(k)).
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September 15, 2021 Medical Devices, Regulatory AffairsWith the Brexit commencement, from Jan 1, 2021, there have been a lot of changes in the UK’s medical devices regulations, which the executive Regulatory Authority in the UK – MHRA has devised. Medical device manufacturers willing to enter the UK market especially, England, Scotland and Wales, will have to follow the applicable MHRA UK regulations.
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September 8, 2021 Medical DevicesMedical devices in Mexico are regulated by the Secretariat of Health (Secretaría de Salud). Article 262 of the Mexican General Health Law requires all medical devices to be registered with the Secretariat of Health before being placed in Mexico. The Federal Commission for Protection of Sanitary Risks (COFEPRIS) oversees the registration process of healthcare products.
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September 7, 2021 Medical DevicesThe application of software technologies in varied healthcare management, including diagnosis or treatment of a disease condition, is accelerating at an unprecedented rate. The global medical device Authorities are revamping their regulations and guidelines to address these booming device technologies.
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September 6, 2021 Medical DevicesMexico is the second-largest market for medical devices in the LATAM region, next to Brazil, and is the import hub for Medical Devices in Latin America.
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September 3, 2021 Medical DevicesThe Brazilian Medical Devices market is growing significantly and is expected to reach USD 1.8 billion by 2023. Medical devices in Brazil are regulated by the National Health Surveillance Agency i.e., ANVISA (Agência Nacional de Vigilância Sanitária).
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September 2, 2021 Medical DevicesThe Health Authorities of all countries, with Canada being an exception, require all foreign medical device manufacturers to appoint a local, in-country or Authorized representative. The duty of a legal representative is to represent the manufacturer and the device in the targeted country and to liaison between Health Authorities and the foreign manufacturers.
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September 2, 2021 Medical DevicesThe Indian medical device industry is amongst the top 20 markets worldwide and considered as one of the fastest growing. Since approximately 80% of the Indian medical device needs are met through imports, it is essential to have a strong medical devices regulatory regime.
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September 1, 2021 Medical DevicesSri Lanka, being majorly driven by imported medical device products, offers a potential market to medical device manufacturers. The medical devices intended to be marketed in Sri Lanka must be registered with the National Medicines Regulatory Authority (NMRA).