On December 4, 2019, the amended Pharmaceuticals and Medical Devices (PMD) Act was published in Japan. While the previously amended PMD Act in 2014 affected all aspects of medical device regulation for Japanese manufacturers, there is now greater emphasis placed on topics such as electronic IFUs (eIFU), Unique Device Identifiers (UDI), Artificial Intelligence (AI) and a rebalance of pre- and post-marketing requirements. (Added guidance will be provided within three years.)
The PMD Act of 2019 includes three main objectives:
- To improve the regulatory process in order to provide drugs and medical devices to patients more safely, quickly and efficiently;
- To revise the roles of pharmacists or pharmacies so that patients can use drugs without anxiety in their regional life; and
- To establish a more reliable legal compliance system.
Points 1 and 3 are of particular importance for medical device organizations with operations in Japan. Manufacturers will need to reevaluate their regulatory strategies and QMS while also keeping in mind the intended enforcement dates.
Table: Contents and Enforcement Dates of PMD Act Amendment (2019)
(from the issue of amendment)
|1-(1)||SAKIGAKE Designation System||Within 1 year|
|1-(2)||Conditional Early Approval System||Within 1 year|
|1-(3)||Early Realization of Change Plan||Within 2 years|
|1-(4)||Post-Market Change Process for Continuously Improved Device||Within 1 year|
|1-(5)||eIFU||Within 2 years|
|1-(6)||Traceability||Within 3 years|
|3-(1)||More Secure Legal Compliance Systems||Within 2 years|
|3-(2)||Penalty Surcharges for Making False/Exaggerated Claims||Within 2 years|
SAKIGAKE Designation System
The SAKIGAKE Designation System was established as a pilot program in 2015, and has now been entered into law. The system aims to promote the research and development of innovative and/or orphan medical products by pairing manufacturers with Pharmaceuticals and Medical Devices Agency (PMDA) partners for prioritized consultation to provide quicker approvals for innovative products. The PMDA website provides more information here.
Conditional Early Approval System
Similar to the SAKIGAKE Designation System, the objective of the Conditional Early Approval System (pilot program established in 2017) is to accelerate the approval of highly needed medical devices where it is difficult to conduct clinical trials due to small patient populations.
By shifting the emphasis of clinical data from pre- to post-market, devices can more readily obtain approval and reach patients more quickly. However, in order for manufacturers to achieve conditional approval, devices must meet a set of criteria to demonstrate safety and efficacy based on available clinical data while also appropriately addressing post-marketing risk management. Post-marketing risk management activities should be planned in collaboration with relevant academic societies. After the risk management measures are properly implemented, and the safety and efficacy of a device are confirmed, the device is approved without conducting new clinical trials. The PMD amendment expands the 2017 pilot program into law.
Early Realization of Change Plan
This provision allows both manufacturers and the PMDA to more effectively monitor the efficacy and safety of medical products, although the details have not yet been finalized. The framework involves review of the change plan during the initial approval/review process, prior to the validation and implementation stage. When a change is required later, it can be conducted by notification instead of partial change amendment, saving considerable time.
Post-Market Change Process for Continuously Improved Device
In addition to the requirements to the Early Realization of Change Plan are those related to the Post-Market Change Process for Continuously Improved Devices, applying to devices that undergo continuous lifecycle improvements. The intention is to promote early introduction of improved features by reducing regulatory burdens. Although details are also under discussion here, the requirement will ensure that a risk management plan is in place for a device prior to any actual product changes. For example, emerging AI technology will need such a framework.
Electronic Instructions for Use (eIFU)
Electronic format distribution of IFUs has been available in Japan for some time, however, the conditions were far from practical under the previous version of the PMD Act of 2014 (i.e. manufacturers must obtain notification that all distributed facilities received the eIFU). The amendment provides measure to streamline this process, allowing manufacturers to provide the latest information to healthcare workers and patients in electronic format.
Improved traceability throughout the supply chain is a key part of medical device safety as it ensures more accurate data management and prevention of errors. Manufacturers must now attach Unique Device Identifiers (UDI), such as barcodes on the packaging of medical products, under UDI requirements. In addition, database registration of product information to marketing authorization holders is being reviewed as a future requirement; the Ministry of Health, Labour and Welfare (MHLW) and the PMDA will continue to promote this to medical practices as an approach to improving safety.
More Secure Legal Compliance System
Japan requires a Marketing Authorization Holder (MAH) for every medical product. The MAH supervises and manages the manufacturer to ensure compliance with all the QMS processes. Unfortunately, the governance has not always worked well in the past due to the management board’s lack of understanding of regulatory compliance and unclear responsibilities. The update to the PMD Act clarifies the division of responsibility between management and site managers, and strengthens the governance and involvement of the management board.
Penalty Surcharges for Making False/Exaggerated Claims
False or exaggerated claims have been a growing problem in the healthcare industry, including promotion of unauthorized off-label use or unapproved indications. The amended PMD Act contains financial penalties to combat such claims.
Taken as a whole, this amendment will impact various aspects of medical device regulation, streamlining some areas and making others more complex. Overall, the changes are in line with other shifts throughout the global regulatory environment, which put patient safety at the forefront.
How Can NAMSA Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with Japan’s PMDA and MHLW. Our internal teams of medical device development experts communicate with Japanese entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers.
NAMSA also provides support to market authorization holders, including implementation of MDR requirements, MDR/IVDR conformity strategies and compilation of appropriate technical documentation for submission to Notified Bodies.
Learn more about NAMSA’s regulatory service offerings by visiting https://www.namsa.com/services/consulting/. We also invite you to get in touch by submitting a request at: https://www.namsa.com/contact-us/.
Takashi Tanaka, PhD, RAC
Takashi Tanaka, PhD, RAC serves as Regulatory Consultant for NAMSA Japan. His past experience as Regulatory Manager at various global medical device companies includes registration for every class of medical device to ensure regulatory compliance. His work covers regulatory strategy assessment, preparation for regulatory documentation, and consultation support with regulatory bodies in Japan. Takashi has a PhD in Medical Sciences received from Kyoto University.