Strategic Approaches to Global Regulatory Success: Effective Global Regulatory Strategy

By Rachel Paul-Zieger and Evangeline Loh

In part 1, Emergo by UL discussed the importance of the intended purpose and the indications for use statements to a medical device. Part 2 elaborates further on the process that should be employed to develop a medical device global regulatory strategy.

Elements of an effective global regulatory strategy

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.

Organizing the regulatory strategy

Once all the priority markets and countries have been identified and the regulatory requirements documented, this should be segmented based on complexity and timelines. The standards and testing requirements as well as regulatory reliance would likely be the first few considerations and dependencies. Alternatively, if the manufacturer has the luxury, this would be developed for one country at a time.

A Gnatt Chart or an Excel spreadsheet can be used to project plan the requirements and where the information for one country can be used to support other regulatory filings.

Concluding remarks

A strategically developed regulatory plan is required to successfully launch a medical device. Even with regulatory harmonization and reliance which facilitates the regulatory process, the device must be safe and effective and possess the evidence to support this.   

We will continue to publish more about global successes. Our next feature is about global regulatory submissions and global quality management systems (QMS). If you are interested in the update from RAPS about the MHRA (U.K.) regulator on the current state of the legislation, access our regulatory update.