By Stewart Eisenhart, Emergo Group
A recent presentation by the Japanese Ministry of Health, Labour and Welfare’s Medical Device Evaluation office has shed more light on planned changes to the country’s medical device market regulatory system.
According to Emergo Group’s Tokyo office, the changes include both high-level amendments to Japan’s Pharmaceutical Affairs Law (PAL) applicable to both medical devices and drugs, and also measures specifically geared toward medical devices.
Proposed changes to medical device regulation in Japan include expanded third-party certification for some Class III devices, new regulatory requirements for certain stand-alone medical software, simplification of medical device licensing, and streamlined PAL quality management system requirements. The MHLW’s Pharmaceuticals and Medical Devices Agency (PMDA) is expected to begin enforcing these changes in November 2014.
PAL changes affecting medical devices
One goal of the PAL reform effort is to develop distinct regulations for medical devices as opposed to rules currently applied to both devices and pharmaceuticals. Among PAL amendments that will have a significant impact on medical device manufacturers are:
- Expansion of private third-party certification to include some highly controlled Class III devices (Currently only certain Class II devices are eligible for third-party certification)
- Stand-alone regulatory requirements for software and programs used to process or store medical data
- Shifting manufacturer licensing and accrediting system for foreign manufacturing facilities to a registration system (In Japan, “manufacturer” means the entity doing manufacturing, not a legal manufacturer who is responsible for the market)
- Elimination of prefect-level quality system inspection requirements
- Streamlining quality system inspections to focus on units of product lines rather than individual
- New “Regenerative Product” category for products not easily classified as either drugs or devices
Accelerated device review plans
In addition to PAL changes, the MHLW also plans to implement an accelerated approval process for medical devices, particularly those deemed highly necessary by the government for public health.
Over a four-year period, Japanese regulators will pursue quality improvements of PMDA application reviews via enhanced training of regulatory staff, more effective consultation with applicants and more standardized evaluations of applications.
By 2018, regulators also intend to set standard evaluation periods for all types of PMDA applications:
|
New medical device |
Improved medical device |
Generic medical device |
|
Normal evaluation: 12 months |
With clinical data: 9 months |
New approval: 5 months |
|
Priority evaluation: 9 months |
Without clinical data: 7 months |
Partial-change approval: 4 months |
To meet these timeframes, the PMDA will shift gradually toward third-party rather than governmental certification for some Class III devices, as well as hold ongoing public-private consultations to evaluate whether measures to accelerate application reviews are working, or if additional steps should be adopted.
Bottom line: Manufacturers eager to commercialize in Japan must currently undergo a highly complex and lengthy medical device registration process. Planned PAL amendments and PMDA medical device registration review changes should ease market entry pathways at least somewhat for many foreign manufacturers.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
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