Convergence: First-year experience with Japan’s amended medical device rules3 min read
Posted 13 September 2021 | By
Kanako Sasaki, PMDA
The changes are part of the Amendment of the Pharmaceutical and Medical Device Act (PMD Act), which was implemented in September 2020. Officials from Japan’s Ministry of Health, Labour and Welfare (MHLW) and the PMDA provided an overview and update on the changes during RAPS Convergence 2021.
Priority and conditional review
The PMD Amendment introduced new provisions to prioritize certain products, including:
- SAKIGAKE designation system
- Priority review for specific uses, such as pediatric use
- Conditional Approval System
- Post-Approval Change Management Protocol (PACMP) for Medical Devices
The SAKIGAKE designation and the conditional early approval reviews had been operated based on the administrative notification process prior to the amendment of the PMD Act.
The SAKIGAKE designation applies to medical devices for severe disease that are deemed safe and effective, innovative, and are being developed initially in Japan. The process allows for prioritized consultation, in which the waiting time is typically shortened from two months to one month, as well as providing a pre-application consultation. There is also a prioritized review that can shrink the targeted review time from 12 to 6 months. Finally, the application is assigned a PMDA manager to help shepherd it through the process, according to Kanako Sasaki, deputy director (international) of the medical device evaluation division in the MHLW.
As of September 2021, two in-vitro devices (IVDs) and 12 medical devices have received the SAKIGAKE designation. Among those, two medical devices and one IVD have been approved, Sasaki said.
The PMD Amendment also allowed products with a specific use for highly unmet medical needs related to pediatric use and antimicrobial resistance to be given priority review. To qualify, devices must satisfy a highly unmet medical need and have excellent efficacy and safety. The priority review shortens the review from a target of 12 to 9 months. Additionally, sponsors can receive tax benefits and grants of subsidy for product development.
The PMD Amendment also created conditional early approval for innovative medical devices in areas of high clinical need. The process shortens the time for collection of clinical data and incorporates a formal post-approval risk management plan and post-approval submission of long-term performance data. “Conditional early approval is applicable when confirmatory clinical trials are not feasible and a certain degree of efficacy and safety is confirmed through other types of studies,” Sasaki said.
The PACMP process allows for continuous improvement through the product life cycle. The process allows for post-marketing data collection based on a pre-planned protocol and potentially a shorter review of the application for expansion. “Using PACMP, manufacturers can change product specifications in the range of the change plan without additional an application,” Sasaki said.
The PACMP process can also be applicable to labeling changes for software for medical devices using artificial intelligence (AI), Sasaki explained.
As of July 2021, the MHLW has received two applications for PACMP: a change plan for an electrode catheter (manufactured by Kaneka Corporation) that would add catheter types and sizes and a change plan for an advanced bipolar device (manufactured by Johnson & Johnson K.K.) that would add components with a different jaw shape.
Japanese health officials also outlined their strategic plan for international cooperation around the regulation of medical devices. The plan’s goals include globally disseminating information on regulatory innovation, contributing to international regulatory harmonization, increasing the efficiency of inspections, and providing training to build regulatory capacity in partner countries, according to Hiroto Inuzuka, coordinator of the Office of International Programs at the PMDA.
Since 2003, the United States and Japan have been involved in a Harmonization by Doing (HBD) project focused on promoting medical device development through convergence in evaluation and regulatory strategy. The program was first developed to decrease the time lag between medical device approvals that typically happened first in Europe and the United States, before making their way to Japan, Inuzuka explained.
“We tried to detect similarities and differences between Japan and the United States in the development of innovative medical devices,” Inuzuka said.
The project has included regulators, as well as representatives from industry and academia. Some current projects are focused on the development of a CD34 antibody coated drug eluted stent, transcatheter mitral value replacement, a device for critical limb ischemia (CLI) treatment, and pediatric medical devices.
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