Device Harmonization Efforts In Asia Still Far From Implementation And Enforcement
This article was originally published in PharmAsia News
Executive Summary
After a decade of work, the Global Harmonization Task Force concludes its mission to align medical device regulations, but how far off is implementation?
TOKYO – The Global Harmonization Task Force, initiated in 1992 to address medical device regulations, concluded its final meeting in early November. It brings an end to a chapter of efforts to align device regulations, and device agency officials now have their targets set squarely on broader implementation.
GHTF was launched to encourage convergence in device regulatory practices through publishing harmonized guidance documents. But in Tokyo at GHTF’s final meeting, members lamented the insufficient implementation of the documents. GHTF’s successor, the International Medical Device Regulators Forum (IMDRF), is hoped to accelerate implementation, relying in part on guidance developed through GHTF (Also see "As GHTF Ends, Industry Cautiously Optimistic On Future Harmonization Progress Under IMDRF" - Medtech Insight, 5 Nov, 2012.).
The problem with implementation of the current harmonized regulations is a matter of scope, as many GHTF members noted during the Oct. 31 - Nov. 1 conference. “The current GHTF documents have been too ambitious. We need a piecemeal approach, and first we have to start with definitions, said Isabelle Demade, the principal administrator at the European Commission’s Directorate General for Health and Consumers.
Of course, defining terms has already been a key component of harmonization efforts. GHTF operated as five study groups. Study Group 1 tasked with supporting the convergence of guidelines, tackled definitions for key terms such as “medical device” versus “in vitro diagnostic.” Study Group 2 addressed harmonized adverse event reporting. Study Group 3 examined quality system requirements in member countries, Study Group 4 developed guidelines for regulatory auditing of quality management systems, and Study Group 5 addressed convergence of clinical evidence requirements.
Regionally, Asia Pacific has some catching up to do in terms of regulatory harmonization implementation. Demade pointed to the lack of implementation on Study Group 2 guidance. Device agencies in Hong Kong and Taiwan have implemented nearly all of Study Group 2 guidance into their regulations, but South Korea, Singapore and the Philippines have barely scratched the surface.
Of course, for a regulatory agency to implement harmonized guidance, they actually have to have regulatory systems in place.
According to World Health Organization findings, only 65% of the countries it monitors have regulatory systems in place for medical devices. Fortunately, this is up from the previous 30% WHO found. Still, WHO found the regulations that are in place do a poor job of covering in vitro diagnostics, and in general found poorly enforced regulation. Perhaps not surprisingly, WHO found production of in vitro diagnostics for high-burden diseases is moving to countries with less stringent regulations. WHO offers prequalification for device manufacturers that provide safe technology; currently four countries – the U.S., China, India and South Korea - contribute more than 75% of the prequalification applications.
Implementation of the guidelines developed from these working groups has varied from country to country. As regulatory agencies look to the next stage of harmonization, it bears looking at how key agencies have handled harmonization efforts up to now.
Australia All In
On one end of the spectrum, Australia actively sought to implement GHTF guidance “in a significant way,” according to Therapeutics Goods Administration’s Monitoring and Compliance Coordinator Larry Kelly.
TGA previously applied a “one-size-fits-all” approach for drugs and devices, which didn’t fit well for the nature of devices, Kelly said. As GHTF developed new guidance, TGA was searching for a new approach, and in 2002 began to adopt almost the entirety of the GHTF framework over a five-year period. TGA is now two years into a four-year process to transition to a new in vitro diagnostics framework as well. But even with that level of commitment, Kelly noted the need for a “more granular guidance” from IMDRF. Kelly serves currently as the chair of the IMDRF management committee.
U.S. Legislative Roadblock
For U.S. FDA, there have been guidance documents generated from GHTF, particularly from Study Group 1, that have been difficult to adapt. FDA Center for Devices and Radiological Health Associate Director, International Affairs, Kimberly Trautman said much of the high-level guidance generated in Study Group 1 would require changes to U.S. legislation to be implemented, which presents a massive road block to implementation.
FDA adapted a version of the Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED), and placed it on the U.S. Federal Registry. Trautman noted, however, the agency believes STED as it appears now requires more granularity. FDA found several documents from Study Group 2 to be essential, particularly on how to handle information related to vigilance reporting and requirements for postmarket surveillance.
Beyond the scope of GHTF, FDA issued three draft initiatives in October related to Medical Device User Fee Amendement III: draft guidance on the agency’s eCopy Program for device submissions, and guidances on the agency’s review clock and goals for premarket approval applications and premarket notification 510(k) submissions.
“We are really looking for international partners for guidance from industry and FDA staff on factors to consider when making benefit-risk determinations in medical device premarket approvals and de novo classifcations,” Trautman told GHTF representatives.
Trautman also highlighted the agency’s new voluntary audit report submission pilot program, though she noted that participation is low. Only six manufacturers have submitted reports, but all six were successful in receiving a one-year reprieve from agency inspections (Also see "Manufacturers Share Doubts About FDA’s ISO 13485 Audit Report Program" - Medtech Insight, 30 Apr, 2012.).
Translation Slows Implementation In Japan
MHLW Associate Director, Office of Medical Device Evaluation, Kentaro Azuma said translating guidance from English into Japanese has slowed the process of implementation.
Still, Japan began to revise its Pharmaceutical Affairs Law in 2002 to incorporate guidance from GHTF. Device classification and STED guidance were added to PAL in 2002. STED was introduced on a trial basis until becoming mandatory in 2005.
As a next step, Japan’s Ministry of Health, Labor and Welfare has also – as part of the country’s Life Innovation 5-year Strategy – proposed establishing a license system for medical device manufacturers, guidance for approvals of me-too devices and regulation on QMS audits. Azuma said the ministry intends to submit the bill to the 2013 ordinary Diet session.
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