Category: Medical devices

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Important Update for UK Assistive Technology Providers! The UK government has revised its guidance regarding which assistive technologies qualify as medical devices, necessitating a conformity assessment. Assistive technology includes innovative products and systems designed to support individuals with disabilities, mobility restrictions, or impairments, making challenging…

Great News for Medical Device Companies in Malaysia! The Malaysian government has launched a new, expedited approval process for establishment license applications. Complete applications will now be processed within just 14-21 working days! 📝 Key documentation required includes: 1. An updated Letter of Authorization (LOA)…

Big News for Medical Device Registration in India! India has enhanced its online portal for medical device registration, introducing new and efficient features to streamline the process. The updated portal now includes: 1. Online Application Submission 2. Application Tracking 3. Workflow-Enabled System 4. Timely Alerts…

New Guidance Alert for Medical Device Manufacturers! The Medical Device Coordination Group (MDCG) has released the MDCG 2024-3 Guidance detailing the essential elements of a Clinical Investigation Plan (CIP) for medical devices. This comprehensive guide covers everything from the rationale and objectives to design methodology,…

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France Embraces English for Medical Device Instructions and Labels! France has made a significant change by now accepting English for Instructions for Use (IFUs) and labels on certain categories of medical devices, specifically those used by professionals. This marks a progressive shift and helps streamline…

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International Associates is very excited to announce that its managing director, Martin Coles, has been shortlisted as a candidate for election to the Board of Directors at hashtag#APSCA to become a C-Member Firm Representative. Voting become possible online through Member Firm access to APSCA’s website…

𝐅𝐨𝐬𝐭𝐞𝐫𝐢𝐧𝐠 𝐆𝐥𝐨𝐛𝐚𝐥 𝐒𝐮𝐬𝐭𝐚𝐢𝐧𝐚𝐛𝐢𝐥𝐢𝐭𝐲: 𝐒𝐌𝐄𝐓𝐀 𝐀𝐮𝐝𝐢𝐭𝐬 𝐚𝐭 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐀𝐬𝐬𝐨𝐜𝐢𝐚𝐭𝐞𝐬 𝐋𝐢𝐦𝐢𝐭𝐞𝐝 Discover SMETA, a globally renowned audit aimed at improving workplace conditions and environmental performance throughout various industries and supply chains worldwide. 🌍At International Associates Limited, we conduct SEDEX audits in nearly 40 sectors, including agriculture, textiles,…