BeautyMatter’s Post

Where to go, FDA or NMPA in China? Background Unlike politic conflict, there are many friendly similarities in these 2 most complex agencies from legislative to registration. We want to compare US and Chinese markets of medical device in an easy and competitive way. From our view, Chinese authority National Medical Products Administration (NMPA) has followed a lot from the most modern U.S. Food and Drug Administration (FDA) and expanded and improved even a bit with Chinese elements. Compared to NMPA, FDA has its Federal Food, Drug, and Cosmetic Act (FD&C Act) already in 1938. Its legislative and standards are still state of the regulatory art in global compliance. See our article and watch video 📻 https://lnkd.in/eEb2Ba9r https://lnkd.in/ekt7Cg2Q Do you want to know more insight more than these main registration factors, you can visit our one year academy with personal coach.   How about to have us as interim manager? Contact us for a free gap analysis of market entry in China. Understanding global landscape of compliance is our enthusiasm. We wish to break next registration record with you. [email protected] 017638379004 #onlinecourse #regulatoryaffairs #Compliance #NMPA #MedicalDeviceCompliance #registration #medicaldevice #legislation #mdr #change #FDA #classification #technicaldocumentation #elearning #CFR820 #typetesting #timetomarket #ISO13485 #Productcode #postmarketsurveillance #deign #testing #Training #strategy #project #PMO

📰 Our September #medtech news is now available. Making the roundup this month: 👩⚕️ New procedures from Swissmedic for submitting clinical trials applications 📑 The latest from EMA regarding the use of LLMs 🏥 A survey from the #eucommission on eIFU for #medicaldevices used by healthcare professionals 📝 New draft guidances from the FDA related to its ASCA Program, and chemical analysis for medical device #biocompatibility assessment 💉 An historic proposal from China’s NMPA regarding its #medicaldevice regulation Read the full bulletin at the link below 👇 https://lnkd.in/dukXv428 #regulatoryaffairs #clinicalaffairs

WHY NOT? I spent most of my time over the weekend and last night to get this certification done. 😀 I’m happy to announce I have completed the course and testing requirements for " Global Regulatory Strategy for Medical Devices", continuing to learn and grow all aspects of my contributions and commitments to our global customers. Risk Classes for Medical Devices: GHTF (Global Harmonization Task Force): Class A, Class B, Class C, Class D Australia: Class I, Class IIa, Class IIb, Class III Brazil: Class I, Class II, Class III, Class IV Canada: Class I, Class II, Class III, Class IV China: Class I, Class II, Class III India: Class B, Class C, Class D EU: Class I, Class IIa, Class IIb, Class III Japan: Class I, Class II, Class III, Class IV US: Class I, Class II, Class III Global Regulatory Agencies: US Food and Drug Administration      fda.gov IMDRF (International Medical Device Regulators Forum)    imdrf.org Health Canada     hc-sc.gc.ca ANVISA (Agência Nacional de Vigilância Sanitária) gov.br /anvisa/pt-br/english NMPA (China) english.nmpa.gov.cn       Industry Associations (Regulatory): Advanced Medical Technology Association      advamed.org   International Organization for Standardization      iso.org    Medical Device Manufacturer Association      medicaldevices.org   MedTech (Canada)     medtechcanada.org RAPS      raps.org #medicaldevices #regulatoryaffairs #medicaldeviceregulation #iso13485 #medtech

Check out our MDRu (Medical Devices Regulatory-support unit) LinkedIn page and discover more about our innovative solutions on our new website: medicaldevices.ipn.pt. Your journey toward regulatory excellence begins here! Sandra Balseiro Natalia de Souza Lescura Luiz de Pádua Queiroz Júnior Celeste Oliveira Ana Brito Raquel Gomes Stephanie Batista Niño #regulatoryaffairs #regulatorycompliance #medicaldevices #ivd #samd

🔎 Seeking Regulatory Support for your Medical Device, IVD, or SaMD? Look no further! Instituto Pedro Nunes' Medical Devices Regulatory-support unit (MDRu) is here to provide support tailored to your needs. 🔗 Check the site at https://lnkd.in/dt4tQYNy ⚙ Why Choose MDRu? Our team comprises experts in medical devices, IVD, and SaMD regulatory affairs, and they are here to guide you every step of the way, ensuring that your innovations reach the market quickly and efficiently. 🌐 Whether you're a startup or an established entity, we offer a range of services to ensure regulatory compliance throughout your product's lifecycle. 🤝 Our approach involves personalized consultations to address your specific regulatory challenges, such as: - Global Markets Certifications: CE, FDA, ANVISA, UKCA - Quality Management System ISO 13485 - Implementation and Adaptation - Technical Reports: CER, BER, PER, PSUR, PMSR - Gap Analysis: Cybersecurity, Requirements, Risk Evaluation - Consulting hours and training 💡 Let's work together to navigate the regulatory pathway, ensuring compliance and success for your innovations in healthcare. #institutopedronunes #regulatoryaffairs #MDRu #medicaldevices #ivd #samd #medicalaffairs #MDR #IVDR #QMS #FDA #ANVISA #CER #BER 

The Thai FDA, Medical Device Control Division, has implemented five innovations to improve the registration process.   Emergo by UL with one of our SMEs, Sreenu Babu, reports on these five new methods to speed-up the registration process in Thailand: https://lnkd.in/gdHdTjrc.   This would be six approaches, if one factored the Regulatory Reliance Program which leverages Singapore HSA authorizations.   #medicaldevice #regulatory #regulatoryaffairs #regulatorycompliance #EmergobyUL #weareULSolutions #welovewhatwedo #weloveglobalregulatory  

Big News in Medical Device Regulation! The U.S. Food and Drug Administration (FDA) has taken a monumental step towards regulatory harmonization by officially integrating the ISO 13485:2016 into its Quality System Regulation (QSR), under the new title of Quality Management System Regulation (QMSR). This pivotal change, effective from February 2, 2024, aims to streamline quality management system requirements, fostering innovation and ensuring the safety and efficacy of medical devices. By adopting ISO 13485, the FDA aligns U.S. regulations with international standards, reducing redundancy and easing the compliance burden for medical device manufacturers globally. This strategic move not only enhances the efficiency of regulatory processes but also expedites patient access to the latest medical technologies. There is a two-year transition. Will you be ready on Feb 2, 2026? #FDA #MedicalDevices #ISO13485 #RegulatoryHarmonization #Innovation

Emergo by UL shares our second article on the South Korea medical device regulatory system.   In this Regulatory Insight, we (SORA LEE) discuss Korea Good Manufacturing Practice (K-GMP) audits performed by Third Party Auditors (TPA) and the Ministry of Food and Drug Safety (MFDS).   Topics of this Insight include: the different types of K-GMP audits, the different K-GMP Auditing Organizations, areas of importance for a K-GMP audit, common challenges of a K-GMP audit, and some recommendations for how to successfully tackle these.   Read the article to learn more: https://lnkd.in/gB9E3VvV .   Image of a Table from the article on the different K-GMP Auditing Organizations.   This series has been inspired by our successful involvement in the 2024 Korea International Medical & Hospital Equipment Show, KIMES.   In our first Regulatory Update for this series, we shared a primer on the medical device regulatory system in South Korea: https://lnkd.in/gHJp_9KV.   We’re very excited for our next article (JAE YEONG NOH) which discusses the virtues of the Medical Device Single Audit Program (MDSAP) audit results, and how this will potentially facilitate the K-GMP certificate (yeah global regulatory harmonization!). As well as considerations about when not to rely on this.   We’ll continue to share more!   #medicaldevice #regulatory #regulatoryaffairs #regulatorycompliance #MFDS #IMDRF #KGMP #MDSAP #EmergobyUL #weareULSolutions #welovewhatwedo #weloveglobalregulatory

Check out our MDRu (Medical Devices Regulatory-support unit) LinkedIn page and discover more about our innovative solutions on our new website: medicaldevices.ipn.pt. Your journey toward regulatory excellence begins here! Sandra Balseiro Natalia de Souza Lescura Celeste Oliveira Ana Brito Raquel Gomes Stephanie Batista Niño #regulatoryaffairs #regulatorycompliance #medicaldevices #ivd #samd

Do you want to enter a new market for your medical device? With our cutting-edge regulatory affairs technology, you can start a device-specific registration in over 140 countries in less than a minute and have customized submission files and process management in less than five minutes. 🇨🇳 Find China-specific regulatory information at https://hubs.ly/Q02sX1tj0. #ArazyGroup #RegTech #RegTechAI #RegulatoryAffairs #Medtech #RegUpdate #RegulatoryUpdate