Emergo by UL presented some of the elements to consider as part of the regulatory strategy: market and sales potential, reimbursement possibilities, academic and physician interest, and the regulatory system, including global harmonization or reliance.
We use the example of South Korea where because of the public healthcare system (95% universal public healthcare system, 1989 National Health Insurance system), reimbursement can and is often submitted at the same time as the device registration. Physician interest may be important if they publish on the use of the device, as this can become clinical data to support other regulatory authorizations.
Understanding the regulatory requirements
In addition to these factors, the requirements of the regulatory system should be assessed, not a complete list: classification, clinical data, regulatory pathways, timeline, global testing (standards), dependence on Quality Management System (QMS), and other regulatory documents required such as Certificate of Free Sale (CFS) or Certificate of Foreign Government (CFG). The classification, clinical data requirements and regulatory pathways available, are often dictated by the competitors on the market, so assessing novel, substantial equivalence (predicate), equivalent, and similar devices is pivotal.
Compliance to international standards is ideal. State Council Order No. 739 and the Regulations for Management of Medical Device Registration Self-Testing (Announcement No. 126/2021) in China, establishes acceptance of testing provided by manufacturers, self-testing. However, in reality, for foreign manufacturers, the most efficient approach is to perform device testing in an authorized lab in China. And, while the CFS or CFG is still needed in China because of the country of origin requirement, the proposed draft Medical Device Management Law would change that.
Strategic Approaches to Global Regulatory Success: Effective Global Regulatory Strategy
This feature focuses on what to consider in developing an effective global regulatory strategy. Learning objective 2 during our sponsored RAPS 2024 session titled Navigating and Managing the Global Regulatory Landscape: Strategic Approaches for Success, re
www.emergobyul.com
