Regulation of Medical Devices: Importance of a Globally Harmonized Approach Nicole Taylor Smith, JD September 2017

How do we work in a Global Marketplace and Rapidly Changing Regulatory Environment ?

Dynamic Regulatory Environment - External Influencers Globalization Economic Climate Cultural Environment Lifestyle & Demography Patient needs Socio-economic trends Political/Legal Environment New/Disruptive Technologies Uncertainties Technology

Good Regulatory Practices Effective regulatory systems are an essential component of health system strengthening and contribute to better public health outcomes Inefficient regulatory systems themselves can be a barrier to access to safe, effective, and quality medical products World Health Organization Resolution, WHA 67.20 (2014)

Good Regulatory Practices Built on a foundation of transparency, good governance, and sound government policy making, GRPs help ensure that national regulatory systems, and international regulator cooperation programs, remain relevant, current, and flexible as technology evolves and unforeseen needs and emergencies occur. GRP contributes to efforts to promote convergence of international regulatory requirements and practices, as well as harmonization efforts http://www.who.int/medicines/areas/quality_safety/quality_assurance/GoodRegulatory_PracticesPublicConsult.pdf?ua=1

Components of Good Regulatory Practices GRP Legality Impartiality Consistency Efficiency Flexibly Effectiveness Clarity Proportionality Transparency

Regulation of Medical Devices: Importance of a Globally Harmonized Approach Benefits for: Regulators Regulated Industry Patients …

Benefits - Regulators Quality of Submissions and Compliance Supports Innovation Leverage resources Share information Collaboration Efficiencies Monitoring Good Regulatory Practice Why is it important? Components of GRP and tools for implementation International Medical Device Regulators Forum (IMDRF) Background and Mission IMDRF Work Items            

Benefits - Regulated Quicker Access Frees up resources for innovation Decisions on where to market products Predictability and transparency – good for regulators and industry Good Regulatory Practice Why is it important? Components of GRP and tools for implementation International Medical Device Regulators Forum (IMDRF) Background and Mission IMDRF Work Items            

Benefits - Patients Safety and Quality of Products Innovative products – development and time to market Access to life saving therapies in expedited manner Good Regulatory Practice Why is it important? Components of GRP and tools for implementation International Medical Device Regulators Forum (IMDRF) Background and Mission IMDRF Work Items            

Use of Standards to Support Global Harmonization Device Standards represent a consensus of requirements that foster innovation while protecting public health. ISO 16142-1:2016(E) “identifies significant standards and guides that can be used in the assessment of conformity of a medical device to the recognized essential Essential principals of safety and conformancy provide broad, high-level, criteria for design, production and post-product (including post-market surveillance) throughout the life-cycle of all medical devices, ensuring their safety and performance. The concept is intended to encourage convergence in the evolution of regulatory systems for medical devices.

ISO 16142-2:2017(E): Harmonized compliance with the regulations, a key element of timely market introduction of advance technology, can be facilitated by the appropriate use of relevant medical device standards. This is based on the premise that standards are based on experience or, in other words, are retrospective, innovation can present unanticipated challenges to experience, rigid, mandatory, application of standards can deter innovation, operation of quality management system, subject to assessment, has become widely acknowledged as a fundamental and effective tool for the protection of public health, quality management systems include provisions that address both innovation and experience, and such provisions of quality management systems include field experience, risk analysis and risk management, phased reviews, documentation and record keeping, as well as the use of product and process standards.

IMDRF Work Item: Standards (Improving the quality of international medical device standards for regulatory use) Purpose: Identify and explore possibilities to improve the process of developing international standards used for regulatory purpose in the medical technology domain The IMDRF Strategic Plan 2015-2020 includes among its priorities “improving the suitability of international standards for regulatory authorities and effective regulatory authority involvement at each stage in standards development.”

Resources https://www.fda.gov/Training/CDRHLearn/ucm206272.htm