How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the ...
Following their adoption by the European Parliament in April 2017, the final versions of the Medical Devices Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR") were published in the ...
The European Union's Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) compliance deadlines are just around the corner. However, with the transition or ‘standstill’ period ...
South Korea’s medical device market is rapidly expanding, driven by technological innovations and increasing healthcare demands. As the market grows, understanding Korean medical device regulations is ...
Great Britain is entering a new era of MedTech regulation, with major pre-market changes expected that are designed to ...
The Central Drugs Standard Control Organisation (CDSCO) has issued a draft guidance document on medical device software to bring more clarity on the regulatory aspects of their usage. The document, ...
Computer software used in healthcare device applications developed for demographic data gathering, physical examinations or therapies are increasingly part of the regulatory landscape. This article, ...
As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...
Altamira Therapeutics Announces Certification of Bentrio Nasal Spray under Medical Device Regulation
HAMILTON, BERMUDA / ACCESS Newswire / November 20, 2025 / Altamira Therapeutics Ltd. ("Altamira" or the "Company") (OTCQB:CYTOF), a company dedicated to developing and supplying nucleic acid delivery ...
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