This episode explores how medical device manufacturers can effectively use their existing CE mark clinical data for an FDA De Novo submission for a novel technology. We delve into the FDA's expectations for foreign data, common gaps between EU and US requirements, and the strategic importance of the Pre-Submission program to de-risk market entry.

• Can you directly use your CE mark clinical study for an FDA De Novo submission?

• What are the most common data gaps the FDA identifies in European studies?

• How does the FDA's view on patient demographics differ from European regulators?

• Why might the standard of care in your EU study be a problem for the FDA?

• Is a US-based clinical trial always necessary if you already have CE mark data?

• What is a "bridging study" and when might you need one?

• How can a Pre-Submission meeting with the FDA save you time and money?

• What key FDA guidance from April 2015 governs the use of foreign clinical data?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

This episode demystifies the process for manufacturers who have an EU CE mark under the MDR and are seeking FDA 510(k) clearance. We break down the crucial differences and similarities between the two regulatory systems, explaining how to leverage existing technical documentation and what new requirements and strategic considerations, like selecting a predicate device, you will face when entering the United States market.

Key Questions:

• Does an EU CE mark give my device an advantage with the FDA?

• What is "Substantial Equivalence" and why is it crucial for a 510(k)?

• How can I reuse my MDR technical documentation for an FDA submission?

• What are the key differences between EU and US quality system requirements?

• Is my ISO 13485 certification enough for the FDA?

• What is the mandatory eSTAR format for 510(k) submissions that started on October 1, 2023?

• Why do I need to appoint a US Agent?

• What are the biggest gaps between a CE technical file and a 510(k) submission?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

Navigating Japan's rigorous PMDA approval process can be challenging, even for devices that already have a CE mark. This episode demystifies the requirements for a Shonin application, explaining how manufacturers can leverage their existing CE mark data. We break down the critical differences and synergies between the EU and Japanese regulatory systems, from Quality Management Systems and technical documentation to the all-important clinical data requirements and the mandatory role of a local Marketing Authorization Holder (MAH).

Key Questions:

• Does a CE mark guarantee PMDA approval in Japan?

• Can my ISO 13485 certificate satisfy Japan's QMS requirements under MHLW Ordinance No. 169?

• What is the STED (Summary Technical Documentation) and how does it differ from my EU Technical File?

• Must all documentation be submitted in Japanese?

• Will my European clinical data and CER be accepted by the PMDA?

• What are the common reasons the PMDA might require a new clinical trial in Japan?

• What is a Marketing Authorization Holder (MAH) and why is one essential for market entry?

• How does the Medical Device Single Audit Program (MDSAP) affect the process?

• What were the key changes in the March 2024 QMS compliance deadline?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

This episode demystifies the process of bringing a CE-marked medical device to the Brazilian market. We break down the critical differences between European requirements and Brazil's ANVISA regulations, focusing on the essential documentation, testing, and certification gaps that manufacturers must address for successful registration.

• Is a CE mark enough to sell your medical device in Brazil?

• What is a Brazil Registration Holder (BRH) and why is it mandatory?

• How does ANVISA's technical dossier differ from a European Technical File?

• Can an MDSAP certificate replace the need for an ANVISA factory inspection?

• What is INMETRO certification and does my electrical device require it?

• Are my existing ISO 10993 biocompatibility test reports valid for Brazil?

• How has the new RDC 751/2022 regulation changed the registration process?

• What are the strict translation requirements for ANVISA submissions?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

This episode details the strategic process for transitioning a medical device with a European CE mark under MDR to achieve Class II or III registration with China's NMPA. We break down the unique requirements, from local representation to in-country testing and clinical evaluation pathways, providing a clear roadmap for manufacturers looking to enter the complex but lucrative Chinese market.

Key Questions:

• Is a CE mark sufficient for selling a medical device in China?

• What is a Product Technical Requirement (PTR) and why is it essential for NMPA registration?

• Can we use our existing EU clinical data for the Chinese submission?

• What are the mandatory in-country testing requirements in China?

• How long does the NMPA approval process typically take for Class II and III devices?

• What is the role of a mandatory China Agent in the registration process?

• Can our device qualify for an exemption from clinical trials in China?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

This episode demystifies the process for CE-marked device manufacturers to obtain a Health Canada Medical Device Establishment Licence (MDEL) for selling in Canada. We break down the crucial differences between an MDEL and a product-specific Medical Device Licence (MDL), clarify who needs to hold an MDEL, and explain why having a CE mark is not a substitute for this essential Canadian requirement. Learn about the key procedural documentation needed for a successful application and the latest guidance from Health Canada.

Key Questions:

• What is a Health Canada MDEL and how does it differ from an MDL?

• If our device has a CE mark, do we still need an MDEL to sell in Canada?

• Who is legally required to hold an MDEL?

• Can a foreign manufacturer or distributor apply for an MDEL directly?

• What are the core procedural requirements for a successful MDEL application?

• How does the new GUI-0016 guidance, effective December 2024, impact applicants?

• Does having an MDSAP certificate exempt a company from needing an MDEL?

• What activities are covered by a Medical Device Establishment Licence?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

This episode breaks down the essential steps for medical device manufacturers with a CE mark to comply with UK regulations for Great Britain. We cover the extended deadlines for CE mark recognition, the immediate requirements for MHRA registration and appointing a UK Responsible Person (UKRP), and the process for achieving UKCA conformity assessment. Learn the key dates and actions you need to take to ensure uninterrupted market access.

Key Questions:

• Is my CE mark still valid for selling medical devices in Great Britain?

• What are the new deadlines for transitioning from CE to UKCA marking?

• Do I need to switch to the UKCA mark immediately?

• What is a UK Responsible Person (UKRP) and do I need one?

• What is the first step I must take to place my device on the UK market?

• How does the UKCA conformity assessment process differ from the CE marking process?

• Are my existing CE technical files useful for the UKCA mark?

• What are the specific labelling requirements for the UKCA mark?

• Do the same rules apply to Northern Ireland?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

This episode provides a focused guide to Japan's medical device regulations. We explore the relationship between the overarching PMD Act and the detailed QMS requirements of MHLW Ordinance 169. Learn about the crucial 2021 harmonization with ISO 13485:2016, the key differences that remain, and how the Japanese audit process presents unique challenges for foreign manufacturers, including an expanded audit scope and specific documentation demands.

Key Questions:

• What is the relationship between Japan's PMD Act and MHLW Ordinance 169?

• Is my ISO 13485:2016 certification enough to sell my medical device in Japan?

• What are the key "gaps" between Japan's QMS requirements and ISO 13485?

• How has the March 25, 2024, deadline impacted QMS compliance for Japan?

• What is a "Medical Device File" and how does it differ from an EU Technical File?

• Who gets audited during a Japanese QMS conformity assessment?

• What are the specific document and record retention rules under Ordinance 169?

• Why is the Marketing Authorization Holder (MAH) so vital for regulatory success in Japan?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

This episode delves into the landmark revision of China's medical device regulations, State Council Order No. 739, which took effect on June 1, 2021. We break down the critical changes impacting global MedTech manufacturers, from the revolutionary Marketing Authorization Holder (MAH) system to new clinical evaluation pathways and heightened post-market responsibilities.

Key Questions:

• What is the new Marketing Authorization Holder (MAH) system and how does it change liability?

• Can you now use your own company's testing data for NMPA submissions?

• What are the new pathways for conditional or expedited approval in China?

• How have clinical evaluation requirements been relaxed for certain devices?

• What are the increased penalties for non-compliance under Order 739?

• Why is the Unique Device Identification (UDI) system critical for post-market surveillance?

• How does Order 739 impact foreign manufacturers specifically?

• What new responsibilities do legal representatives and senior management now face?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.

This episode provides a deep dive into India's Medical Device Rules, 2017, and the subsequent amendments through 2023. We explore the shift to a risk-based classification system, new Quality Management System (QMS) and licensing requirements, and the critical role of the Central Drugs Standard Control Organization (CDSCO). The discussion covers practical implications for manufacturers, including post-market surveillance, vigilance, and the latest 2023 updates to the regulatory framework.

• What were the landmark changes introduced by the Medical Device Rules, 2017?

• How does India's risk-based classification system (Class A-D) impact your device's path to market?

• What are the new Quality Management System requirements for manufacturers?

• How has the licensing process changed, and what is the role of the India Authorized Agent?

• What are your post-market surveillance and vigilance responsibilities under the current rules?

• What specific updates were made in the June 2023 amendment?

• Is your foreign manufacturing site subject to inspection by the CDSCO?

• How do you navigate the SUGAM online portal for submissions?

Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide, including India. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.