June Newsletter 2024
We’re excited to share the latest updates and insights in our June newsletter! What’s Inside!! Read detailed information below: https://omcmedical.com/wp-content/uploads/2024/07/June-Newsletter-2024-English.pdf...
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Medical Taiwan 2024: Exploring Global and Multi-Industry Innovations in Smart Medicine and Healthcare
Taipei Nangang Exhibition Center Hall 2 (TaiNex2) will host Medical Taiwan, the main international expo for the medical, health, and care industries, which is organized by TAITRA, from June 20 to 22, 2024. The previous year, when the pandemic was winding down, the event managed to draw in close to a thousand foreign customers from 53 different nations. Interestingly, among these guests, quarters belonged to procurement or senior decision-making staff. For those involved in the field, Medical Tai...
eCTD- Electronic Common Technical Document
eCTD-an overview In today’s economy, life science companies are seeking for strategies to continue growing despite impending patent expirations, increasing generic competition, and rising drug development costs. The International Conference on Harmonization (ICH) created the Common Technical Document (CTD), which is quickly replacing other submission formats as the preferred or compulsory one by regulators in the major global markets and beyond. In Europe, Japan, and Canada, the CTD has be...
Manual on Borderline and Classification of Medical Devices
New guidelines on how to distinguish between medical devices and medical products under the Medical Devices Regulation have been published by a working group of the European Commission (MDR). The new recommendations from the European Medical Device Coordination Group (MDCG) cover “borderline products” that are difficult to classify as either medical devices subject to the MDR requirements or medical products for human use subject to the requirements of Directive 2001/83/EC (MPD) for CE...
Animal Testing for Cosmetics
The term “animal testing” refers to procedures carried out on living animals for research into basic biology and diseases, evaluating the efficacy of new pharmaceuticals, and testing the safety of consumer and industry products such as cosmetics, household cleaners, food additives, pharmaceuticals, and industrial/agrochemicals for human health and/or the environment. Since 1937, people have used animals to test cosmetics and pharmaceuticals. To determine a product’s safety, manufacturers w...
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...
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...
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,...
Top 7 Guidance On Class I Medical Devices
The EU MDR 2017/745 imposes more stringent requirements for Class I devices. Under the new regulations, Manufacturers must righty classify a medical device and provide technical documentation following the device class. The risk class under MDD could change under MDR. In some cases, medical devices could be up classified from Class I medical devices to Class II a/b medical devices or Class III medical devices. Please read our article on the classification of medical devices to understa...
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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If you have any questions or need help, feel free to contact with our team.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
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