WebFeb 22, 2024 · Health Canada and FDA eSTAR fly: Advice to industry [2024-01-10] 2024. Pulse oximeters [2024-12-30] Where Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2024 [2024-12-02] Summary reporting provisions of the Medical Devices Regulations: Notice to industry [2024-11-21] WebTen years of experience in regulatory affairs and global compliance area working with medical devices and cosmetics approvals. Specialized in developing regulatory strategies for innovative products registration all over the world, preparing international regulatory submission deliverables, obtaining and maintaining approvals necessary to market …
Medical Device Establishment Licence (MDEL) application ... - Canada…
WebThe regulations in Canada: Regulatory Authority: Health Canada, Health Products and Food Branch, Therapeutic Products Directorate, Medical Devices Bureau Regulation: Medical Devices Regulations (SOR/98-282) Representative (should be based in country or not): No requirement. Registration timeline: MDEL: 120 calendar days. list trading platforms
Medical device licensing - Canada.ca
WebApr 12, 2024 · The Food and Drug Administration's (FDA, Agency, or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its Radiation Sterilization Master File Pilot Program (``Radiation Pilot Program''). The Radiation Pilot Program is voluntary and intends to allow companies that... WebRegistration 1998-05-07. Medical Devices Regulations. P.C. 1998-783 1998-05-07. His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsections 3 (3), 30 (1) and 37 (1) a of the Food and Drugs Act, hereby makes the annexed Medical Devices Regulations. a S.C. 1993, c. 34, s. 73. WebAug 9, 2024 · A Medical Device Establishment License is required for manufacturers of either Class I medical devices or in-vitro diagnostic (IVD) devices. Distributors and importers of all classification types must also obtain a MDEL permitting the importation and distribution of a medical device in Canada. list travel hack credit cards