Worldwide Medical Device Regulatory Updates

The Global Harmonization Task Force (GHTF) has proposed establishing a standardized grading system for quality management system (QMS) nonconformities, along with a standardized Regulatory Audit Information Exchange Form to provide more consistent ISO 13485:2003 audit data for use between medical device market regulators.

The GHTF’s proposed Regulatory Audit Information Exchange Form includes three parts. First, a list of nonconformities from a QMS audit report is necessary to explain each nonconformity reported. (The nonconformities included in this list should match those listed in the manufacturer’s original audit report.)

Second, details of a Nonconformity Grading System should be included showing how the manufacturer’s final nonconformity grade was determined.

Third, nonconformities pertaining to country-specific medical device regulatory requirements outside the scope of ISO 13485 should be identified in order to provide regulators with a more complete picture of a particular manager’s general state of compliance.

The GHTF’s proposed Nonconformity Grading System entails a two-step approach: Step 1, involving a Nonconformity Classification Matrix to make initial evaluations, and Step 2, which applies escalation rules in order to determine a final grade.

“Currently, the significance of a nonconformity related to a medical device manufacturer’s Quality Management System (QMS) may vary between regulatory authorities and auditing organizations,” the GHTF proposal states. “All parties will benefit through the use of a standardized and transparent grading system of QMS nonconformities to communicate the findings of a regulatory audit, building the confidence necessary for the potential mutual acceptance of the results of a regulatory audit.”

Even though no current standard QMS regulation exists across medical device markets—even among the GHTF founding members, ISO 13485 is not uniformly required—establishing a single method for evaluating quality system nonconformities could lead to a more effective global regulatory approach to medical device quality systems.

In a move likely to boost interest in the Singaporean medical device market, the Health Sciences Authority (HSA), Singapore’s medical device market regulator, plans to implement new rules effective May 1 to provide expedited market access for lower-risk devices.

First, the rules will exempt all Class A medical devices (with the exception of sterile Class A products) from HSA registration requirements. Manufacturers of qualifying devices must still declare their products in their importer and manufacturer licenses, and update their lists of qualifying devices every six months to enable post-market surveillance efforts. Sterile Class A device registrations will have target timelines of 30 days, and fees for these registrations will remain at $25. The HSA estimates that 80% of all Class A devices will qualify for the new registration exemption.

Effective September 1, 2012, the HSA will also establish Immediate and Expedited Registration routes for some Class B devices.

• Immediate Registration Route: allows immediate access to the Singaporean market for Class B devices already approved by at least two independent reference regulatory agencies (US FDA, EU, Health Canada, Therapeutic Goods Administration and/or Japan’s MHLW) and marketed for at least three years with no safety issues
• Expedited Registration Route: 60-day registration periods will be available for Class B devices that have either been approved by at least two independent reference regulatory agencies or approved by one such agency and have been marketed either in Singapore or that agency’s jurisdiction for three years without any safety issues

Second, Singaporean regulators plan to implement a lower-tiered fee structure for Special Authorization Route (SAR) devices starting August 1, 2012. The SAR is designed for innovative, low-cost and low-volume devices. The HSA will temporarily offset SAR fees for all applicants subject to pending registration or change notification that have submitted their applications by December 31, 2012. In addition, eligible SAR applications that have not been approved by the HSA as of April 20, 2012 will be issued refunds.

PricewaterhouseCoopers and mobile operator industry association GSMA expect global mobile health revenues to hit $23 billion by 2017, with the biggest markets in Europe and the Asia-Pacific region.

A new report recently issued by the two entities, Touching lives through mobile health: Assessment of the global market opportunity, projects that European and Asia-Pacific markets will each make up 30% of global mobile health market share, followed by North America (28%), Latin America (7%) and Africa (5%).

Monitoring services—particularly those for aiding chronic disease management and ageing, will constitute about 65%, or $15 billion, of the global medical health market, followed by diagnostic services and healthcare system strengthening services, according to the study. Mobile operators will reap nearly 50% of the growing mobile health market, whereas medical device manufacturers, app developers and healthcare providers will account for the remaining market share.

However, this level of growth depends highly upon global regulators developing effective market authorization requirements that take into account the nature of mobile health products rather than just pigeon-holing these products into regulatory systems designed for more conventional medical devices. PwC and the GSMA acknowledge that regulatory support—as well as acceptance of mobile health devices by healthcare practitioners and consumers—is essential to the realization of the study’s projected growth rates. Although regulators in the US and other highly developed markets have taken initial steps toward developing a more nuanced approach to mobile medical technologies, substantive policies regarding mobile health have yet to fully materialize. Until they do, these study projections should be taken with a healthy grain of salt.

The Global Harmonization Task Force (GHTF) will evolve into the International Medical Device Regulators’ Forum (IMDRF), with the new organization’s inaugural meeting set to take place in Singapore in early 2012.

The IMDRF’s management committee will consist of regulators from Australia, Brazil, Canada, China, the European Union, Japan, the United States and the World Health Organization. Australia will initially lead the new group.

The IIMDRF will continue the GHTF’s effort to push global medical device regulatory harmonization by developing guidance on strategy, policy, directions, membership and activities. The IMDRF will also form ad hoc working groups involving industry, academia, health care experts and patient groups to address various issues.

The GHTF announced plans to reorganize into a new organization in early 2011. The new iteration of the group would be led primarily by regulators, with industry representatives relegated to advisory roles. Based on initial reports of the IMDRF’s management structure, this does indeed appear to be the case.