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Articles

FDA’s Adverse Event Reporting for Cosmetics

Cosmetic ingredients and products are not required to have FDA clearance before being sold in the U.S. The only exception is colour additives, which need to be authorised for their intended purpose (apart from the colouring agents used in coal-tar hair dyes). Companies and individuals that sell cosmetics have a legal obligation to guarantee the security of their products. The FDA requires trustworthy evidence that shows that a cosmetic product is harmful when used as directed by its label or in...
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Cosmetics Product Recall under FDA

Title 21 of the Code of Federal Regulations (CFR), section 7.3(g), describes a recall as a firm’s removal or correction of a marketed product that FDA judges to be in violation of the laws we administer and against which the FDA would start legal action, such as seizure. FDA strongly advises businesses to familiarise themselves with all of the regulations, including the elements of a recall strategy, in 21 CFR Part 7. What is the FDA’s responsibility in a recall of Cosmetics Product? The FD...
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Understanding Borderline Cosmetics in the EU

by OMC Medical | Dec 13, 2023 | Cosmetics, EU Understanding the distinctions between product classes within the European cosmetics landscape can be complex and ambiguous, often requiring input from authoritative bodies. Certain products may share similarities but fall under different regulatory frameworks. When products straddle these frameworks, they’re termed “borderline” by the European Commission (EC). Clear comprehension of a product category is vital to determine the regul...
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Bio Korea 2024 – The Future of Biotechnology Innovation and Global Collaboration

Every year, BIO KOREA organizes the International Convention with the goal of promoting and expanding the bio-health sector worldwide. We are happy to announce that the 19th BIO KOREA will take place at COEX in Seoul from May 8–10, 2024. This year too. Get the chance to network with international academics, professionals, and CEOs in the bio-health field, as well as exchange the latest trends and technologies in the field through BIO KOREA 2024’s Business Partnering, Invest Fair, Exhibition,...
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OMC Medical to Showcase Global Market Access Solutions at KIMES 2024 

OMC Medical Set to Attend KIMES, Invites Participants to Meet at UK Pavilion for Uninterrupted Market Access Solutions  SEOUL, SOUTH KOREA – February 21, 2024 – OMC Medical, a leading provider of regulatory support and market access solutions for medical device, cosmetics, and pharmaceutical manufacturers, announces its participation in the Korea International Medical & Hospital Equipment Show (KIMES) from March 14 to March 17, 2024. The event, one of the largest medical exhibitions in As...
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ARAB Health Event – Unlocking Global Markets

The ARAB Health Event is back and ready to pave the way for groundbreaking advancements in healthcare! This year, we invite you to embark on a journey of discovery as we delve into the theme of “Unlocking Global Markets.” This extraordinary event promises to be a convergence of minds, ideas, and innovations that will shape the future of healthcare on a global scale. Discover Insights on Crucial Topics Unlocking 2024: Navigate the Current UK Landscape UAE: A Prime Market for Medical Device E...
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Updates in ANVISA GMP 2022 document 

Agência Nacional de Vigilância Sanitária – ANVISA is the Regulatory Body of Brazilian government.   What is Good Manufacturing Practice (GMP)?  Good manufacturing practices are the procedures that must be followed in order to comply with the guidelines set forth by regulatory agencies that oversee the authorization and licencing of the manufacture and sale of medical devices.  The GMP document released on 30th March 2022 for Medical and IVD produ...
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Nomenclature of Medical Devices

Medical device nomenclatures are those products used to prevent, diagnose, treat, and monitor the many diseases known to humankind. Medical devices and medicines play an equally important role in treating human beings. To learn more about medical devices, read our article on the definition of a medical device. This article discusses the nomenclature of medical devices and examples of these. What is the Nomenclature of Medical Devices? To simply put it, the nomenclature is the naming of a me...
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EU MDR – Article 117

EU MDR – Article 117 – The French Poly Implant Prostheses (PIP) breast implant controversy prompted medical rules to be revised and formed new Medical Devices and In-Vitro Devices Regulations to safeguard public health. As per the European Medicines Agency (EMA) definition, a medicinal device is a substance or combination of substances intended to treat, prevent or diagnose a disease, or restore, correct or modify physiological functions by exerting a pharmacological immunological...
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Quality Management System Requirements of EU MDR

Quality Management Systems (QMS) are defined by the MDR as formalised systems that document processes, responsibilities, and procedures to ensure and continually improve the standard of company activities. To obtain CE marking and market devices in European Union, an effective Quality Management System that complies with EU MDR 2017/745 is must. Article 10 of EU MDR 2017/745 explains the general obligation of manufacturers to place their products in the EU market. A...
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