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

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

3. 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

4. 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 (2014)

5. 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

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

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

8. 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            

9. 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            

10. 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            

11. Use of Standards to Support Global Harmonization
Device Standards represent a consensus of requirements that foster innovation while protecting public health.
ISO :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.

12. ISO :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.

13. 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 includes among its priorities “improving the suitability of international standards for regulatory authorities and effective regulatory authority involvement at each stage in standards development.”

14. Resources