September 22, 2020
Significant revisions to Japanese regulations of medical devices, IVDs and other healthcare products have begun taking effect, with phased implementations (link in Japanese) of new and updated requirements planned through 2022.
The first round of changes to Japan’s Pharmaceuticals and Medical Devices Act (PMD Act) took effect September 1, 2020. Additional revisions will come into force in August 2021 and December 2022.
On a high level, PMD Act revisions will include new regulatory pathways for some medical products; additional roles and responsibilities for pharmacies in Japan; and clarified requirements for compliance frameworks for licensed entities dealing with medical devices, IVDs and other medical products.
Japanese market registrants should also anticipate stricter procedures for private importation of unregistered medical products as well as stiffer penalties for PMD Act violations, according to Emergo by UL consultants in Tokyo.
Initial round of PMD Act changes: Fast-track reviews
Among the first set of changes to the PMD Act implemented by the Japanese Ministry of Health, Labour and Welfare (MHLW) is the establishment of new registration pathways for specific medical device and IVD types.
First, MHLW has established a fast-track review process (link in Japanese) for pioneering devices and IVDs utilizing novel or breakthrough technologies and intended to treat or diagnose life-threatening diseases, or diseases with no effective alternate treatments; qualifying devices must be submitted for registration in Japan either simultaneously or before submissions to other market regulators. Key considerations regarding the review process include:
- Qualifying for a pioneering medical device or IVD designation entails submitting an application for such designation to MHLW. (Opportunities to submit pioneering device or IVD designation applications will occur twice per year.)
- MHLW reviewers will evaluate applications and determine designations based on input from the Pharmaceutical Affairs and Food Sanitation Council, an advisory body to the ministry.
- Prior to applying for pioneering device or IVD designation, a manufacturer must request a “Pre-Sub” consultation with the Pharmaceuticals and Medical Devices Agency (PMDA) to discuss submission-related issues and challenges with the regulator.
- Review timeframes are expected to be six months.
- Qualifying applicants must meet post-market surveillance as well as re-review/renewal requirements.
Conditional fast-track reviews
PMD Act revisions have also established a conditional fast-track review pathway (link in Japanese) for additional types of medical devices and IVDs. There are two separate sets of criteria through which a device may qualify for this pathway.
The first set of criteria whereby a manufacturer may obtain conditional fast-track review are:
- Product is intended to treat or diagnose a life-threatening illness or one for which not effective treatment currently exists.
- Some clinical evidence already exists supporting product’s safety and effectiveness claims.
- New clinical studies or clinical performance tests for the product are difficult to conduct because of targeted disease’s orphaned status or rare incidence.
- Guidelines for proper use of the product may be established via collaboration with a relevant clinical entity such as the Japanese Society for Cardiovascular Surgery.
- Post-market surveillance processes may be implemented for the product.
Or, a device or IVD may meet a separate set of criteria in order to undergo fast-track Japanese regulatory review:
- Product is designed to physically affect human anatomy or body functions.
- Product is expected to be used for other indications or meet unmet clinical needs.
- Product’s existing clinical data can indirectly support these other indications without the need for additional clinical or non-clinical studies.
- Proper-use guidelines may be established via collaboration with relevant clinical entities or societies.
- Post-market surveillance may be established once the product is commercialized in Japan.
Manufacturers interested in conditional fast-track reviews for their devices will also need to conduct PMDA Pre-Sub consultations. Qualification determinations will be made based on whether devices under consideration are highly needed in the Japanese healthcare system; PMDA will conduct “preferential” reviews of these devices, with nine-month targeted timeframes.
IDATEN review framework
A third new review pathway included in the phase-one PMD Act revision is the Improvement Design within Approval for Timely Evaluation and Notice, or IDATEN, system.
MHLW established IDATEN for medical devices and IVDs expected to undergo ongoing modifications, improvements or phased design changes during their post-market lifecycles.
Manufacturers previously had to file amendment applications each time their PMDA-approved devices underwent improvements or design changes. Although few specifics regarding the IDATEN system have been issued, Emergo by UL anticipates a more simplified process whereby manufacturers of devices such as Software as a Medical Device (SaMD) may maintain their Japanese market registrations while making continuous or phased improvements to their products. We will provide further analysis of the IDATEN framework as details from MHLW become available.
Additional Japanese medical device and IVD regulatory resources:
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