ARPA - Asia Regulatory Professionals Association ’s Post

This year the HPRA is offering two different streams for our graduate programme. Find out more details about each below.   🔗 Stream 1: Medical Devices Here you will learn about how medical devices are placed on the market and how they are maintained through their lifecycle. You will also learn about their different legal requirements. https://lnkd.in/ePMMXSks 🔗 Stream 2: Medicines on our Market Here you will learn about how we monitor the safety of medicines and the regulations that impact how they are distributed and manufactured.  https://lnkd.in/e2UcAsvx

✴ Do I need a Clinical Evaluation Report (CER) if I want to market my medical device in China? ✴ In this post, I would like to talk about the clinical evaluation pathways of medical devices for submission to the Chinese market. ❎ Class I devices: A Class I device does not require a full CER. A basic clinical description is sufficient. ❎ Class II and III: The NMPA has published the "Clinical Evaluation Exempt Catalog for Medical Devices". If your Class II or III device is listed in this catalog, a simple CER with a basic comparison to the predicate device or the appropriate content in the catalog is sufficient. This catalogue is updated regularly. 🔍 If there are differences, you will need to demonstrate that the differences do not adversely affect the safety and effectiveness of the device being evaluated. 🔎 If your device is not a Class I device or is not on the List of Exempted Devices, there are two ways to proceed: 1. Conduct a clinical investigation 2. CER based on equivalent/comparable device pathway What is the difference between an equivalent and a comparable device? 🤔 ◼ Equivalent: either the same intended use, technical characteristics and biological characteristics, or the same intended use, similar technical characteristics and biological characteristics. ❗ Sufficient scientific evidence must be provided to demonstrate that differences in technical and biological characteristics do not significantly affect clinical safety and performance. If this is not possible, a clinical trial must be conducted. ❗ ◼ Comparable: similar intended use, technical and biological characteristics. Have you been involved with CER submissions in China? What is your experience? #clinicalevaluationreport #clinicalevaluation #NMPA #medicaldevice #regulatorywriting #medicalwriting ------------------------------------------------------- If you need help with your clinical evaluation documents, please contact me. 📨

Another great conversation is coming up next month. David Hammond, MS, RAC, CCRP, spent time with us discussing the Regulatory Affairs graduate program at the University of Washington and the challenges the FDA faces with AI-enabled medical devices. #ai #manfuacturing #regualtoryaffairs

The role of Medical Science Liaisons (MSLs) is crucial in Medical Affairs. This tutorial is here to help you measure and communicate the impact of your role effectively. Watch the full tutorial for the needed strategies:

Thailand 🇹🇭 #RegulatoryAffairs update: In an announcement last June 26, 2024, TFDA released an additional list of experts, expert organizations, government agencies, or private organizations, both domestic and international, to perform the evaluation of academic documents on medical devices. Find out more details in our update below 👇

There is a steady and growing demand for Regulatory Affairs professionals, in lignt of the evolving regulatory landscape including the new 2021 European Medical Device Regulation (MDR) and the 2022 In Vitro Diagnostic Device Regulation (IVDR). Our Higher Diploma in Medical Technology for Regulatory Affairs Professionals is a 60-credit NFQ Level 8 award, developed to meet this growing need. Applications close on 14/1/25 for this programme accredited through Atlantic Technological University Galway, which also starts in January 2025. ✅ Unemployed, or those returning to work, may be eligible to have fees covered in full (Free) ✅ Employed people or recent graduates pay just 10% of the course fees (€690) ✅ Places on Springboard+ and HCI courses are limited! Learn more and apply here: https://lnkd.in/efGphk8j Irish Medtech Jennifer Lynch Ann O Carmel McGrath #Funding #Training #HigherEducation #JobSeekers #Grants #CPD #Medtech #Upskill #MDR #IVDR #RegulatoryAffairs

🌟 Excited to Share My Recent Class Activity: Poster Presentation on Article 62 & Article 63 of MDR 🌟 As part of my ongoing studies in medical technology, I had the opportunity to dive deep into the Medical Device Regulation (MDR), particularly Articles 62 and 63, which are pivotal in the context of clinical evaluations and post-market surveillance. 🔍 Article 62 discusses the requirements for clinical evaluations of medical devices, ensuring that devices on the market have sufficient clinical evidence to support their safety and effectiveness. 📊 Article 63 focuses on post-market surveillance, which outlines the process for gathering and assessing data after a device is placed on the market to ensure its continued safety and performance. Presenting the key points and discussions in a poster format was a fantastic way to consolidate my understanding of these essential regulatory requirements. I’ve gained valuable insights into how these articles ensure medical devices remain safe and effective for patients throughout their lifecycle. 🎓 This experience reinforced my passion for regulatory affairs and its importance in the medical technology field. I’m looking forward to continuing to build on this knowledge! #MDR #MedicalDeviceRegulation #ClinicalEvaluation #PostMarketSurveillance #ContinuousLearning #Innovation #RegulatoryAffairs #MedicalTechnology #StudentLife #TUS #Limerick #Ireland #HealthcareCompliance #MedicalDevices #RegulatoryKnowledge

Those of your working in the UK with medical devices may be interested to participate in the MHRA consultation on medical devices regulation changes. 1. As part of the changes they are planning to provide different routes for international recognition. 2. Another interesting part is that the regulator plans to scrap UK conformity assessments to obtain UKCA (UK Conformity Assessed) mark - a move, expected by some of the regulatory affairs experts. However, manufacturers will be required to have ‘Unique Device Identification’ (UDI) registered with MHRA before placing the product on the market. 3. An expected change is to align the UK classification with the International Medical Device Regulators Forum (IMDRF) classification. 4. There will be no special regulation on Artificial Intelligence (AI), which was expected considering the dynamic area. 5. The new regulation will allow to use electronic instructions for use instead of paper ones. 6. Some EU regulations which were supposed to unsetted in May 2025 are now applicable indefinitely until new laws replace them. #medicaldevices #UK #medicaldevicesregulations

Very nice explanation. One image is worth more than one thousand words.

As a regulatory academic, I often feel like an important part of my job is providing a translation service for regulatory rules to non-regulators. In this paper, published today in BMJ Innovations, we explain MDR requirements to people who work on medical device development in a hospital setting. A link to the open access paper is here https://lnkd.in/dNrvau4H #medicaldevices #mdr #research