Medical device Post Marketing Surveillance (PMS), an important practice in the entire pharmacovigilance activity, is the process of ensuring the continued safety and efficacy of the device after it is approved and marketed. When the medical device is launched in the market, it is used by a large number of the general population with various medical conditions.
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September 24, 2021 Medical Devices, Regulatory Affairs -
September 24, 2021 Medical Devices, Regulatory AffairsTherapeutic Goods Administration (TGA), under the ‘Therapeutic Goods Act 1989,’ is entitled to regulate medical devices placed and marketed in Australia. Medical devices are regulated under the Therapeutic Goods (Medical Devices) Regulations, 2002. Initially introduced in 2002, the regulations underwent multiple amendments at a frequency of at least once a year, almost every year.
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September 20, 2021 Medical Devices, Regulatory AffairsThe medical devices market in Mexico is growing significantly and is expected to reach USD 7.6 billion by 2025. It is considered a tough market in terms of medical device regulations. The Federal Commission regulates medical devices in Mexico for the Protection against Sanitary Risk, i.e., COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios).
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September 20, 2021 Medical Devices, Regulatory AffairsA Medical Device Establishment Licence (MDEL) is a license issued to Class I medical device manufacturers, importers, or distributors of all device classes.
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September 20, 2021 Medical Devices, Regulatory AffairsThe 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 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.