WORLDWIDE MARKETING AUTHORIZATION
Canada
Navigating the Canadian medical device landscape demands specialized knowledge, and Panabistics stands ready to guide you every step of the way. Health Canada classifies devices from Class I (lowest risk) to Class IV (highest risk). From determining initial device classification and preparing the necessary Medical Device License (MDL) applications for higher risk devices, to ensuring compliance with the Medical Devices Single Audit Program (MDSAP) requirements, Panabistics has you covered.
Furthermore, for companies seeking a local presence in Canada, Panabistics offers a pivotal service: acting as your Medical Device Establishment License (MDEL) holder. This key provision allows international companies a smoother entry into the Canadian market. With our intricate understanding of the Canadian Medical Device Regulations (CMDR) and our MDEL service, entering and operating in the Canadian medical device market becomes a streamlined experience.
USA
Panabistics offers a comprehensive suite of services tailored to navigate the complexities of the U.S. regulatory environment. The FDA categorizes medical devices into three primary risk classes: Class I (lowest risk), Class II, and Class III (highest risk). Our expertise spans from guiding clients through the nuances of each class, assisting with 510(k) clearance processes, De Novo classification, to the intricate pathways of Pre-market Approval (PMA). While Class I devices, being of lower risk, might not necessitate FDA clearance, we ensure that even the most high-risk Class III devices seamlessly traverse the rigorous review processes. Through every step, Panabistics stands as the stalwart partner, ensuring your medical device aligns with regulatory standards and reaches the market efficiently
EU
Panabistics extends its deep-rooted expertise to the multifaceted regulatory framework of the European Union. With the advent of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), the EU has ushered in a new era of heightened scrutiny and standards. We assist businesses in understanding and navigating the transition from the MDD/IVDD to the MDR/IVDR. Our team is adept at device classification within the EU, guiding clients through conformity assessments, ensuring alignment with Essential Requirements or General Safety and Performance Requirements (GSPRs), and managing the intricate steps to obtain the CE Marking. Additionally, we provide guidance on post-market surveillance, clinical evaluations, and vigilance, ensuring a holistic approach to compliance in the EU market. With Panabistics by your side, the complexities of the European regulatory terrain become navigable, ensuring your product's successful market entrance."
Post-Brexit, the UK’s medical device regulations are governed by the MHRA under the UK Medical Devices Regulations (UK MDR). With the UKCA marking now replacing CE marking, businesses require tailored guidance to ensure compliance.
Panabistics provides expert support in device classification, UKCA certification, regulatory submissions, and post-market surveillance. For international companies, we offer guidance on the UK Responsible Person (UKRP) role, ensuring seamless market access.
With our expertise in MHRA regulations and evolving market dynamics, Panabistics is your strategic partner for successful entry and long-term compliance in the UK MedTech sector.