The Breakthrough Devices Program Guidelines
This Article deals with the Updates for the Breakthrough Devices Program Guidance reducing Disparities in Health and Health Care. The FDA which is an authorized agent for Registrations in the country has developed a draft […]
Read MoreNew Guidelines Implemented by the Philippines FDA
This article deals with the Guidelines on the Food and Drug Administration’s Regulatory Actions during Declared National or State Public Health Emergencies which are being implemented. The FDA is the authorized agent for Medical Device […]
Read MoreFDA Registration – SARS-CoV-2 Molecular Diagnostic Tests
This Article Deals about FDA Registration for Diagnostic Kits. The approved SARS-CoV-2 molecular diagnostics was published on February 21, 2023 by the Food and Drug Administration, USA. These EUAs have been granted with specific authorization requirements […]
Read MoreAmendment in the Drug Rules, CDSCO, MDR India
This article is about MDR India for a notice published in the Indian Gazette on June 14, 2022, by the Indian Government’s Ministry of Health and Family Welfare. The CDSCO is requesting feedback and suggestions […]
Read MoreReclassification of Medical Equipment in Australia
This article discusses about the TGA Regulation the transitional steps that sponsors of medical devices intended to be used in direct contact with the heart and central circulatory system must do in order to be […]
Read MoreNew Framework to Manufacture Innovative Medicines in the UK
This article is about the EU MDR Regulation – Medicines and Healthcare Products Regulatory Agency (MHRA) announcing that the UK will be the first country to introduce a tailored framework for the regulation of innovative […]
Read MoreApply for registration of a Refurbished Medical Device, Malaysia
This Article Deals about the Submission of Medical Device Application for Registration Published by Medical Device Authority of Malaysia. This manual was created to help the manufacturer and Authorized representative while registering a used medical […]
Read MoreMedical Device Approval by Ministry of Public Health, Thailand
This Article deals with the Prescription for some Medical Device advertisements that don’t need medical device approval which is published by the Thailand Government. There are numerous regulations for medical device advertising that are intended […]
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