Qualtech successfully conducted its webinar on September 17, 2026, providing participants with a practical overview of how existing biocompatibility reports can be leveraged for Japan’s PMDA submissions, alongside the key regulatory requirements for digital medical devices under South Korea’s Digital Medical Products Act. The session was presented by Qualtech’s Japan and South Korea registration teams, covering recent regulatory developments and practical considerations for manufacturers seeking market access in these two markets.

1. Japan: Leveraging Existing Biocompatibility Reports for PMDA

1.1. Regulatory Basis

Biological safety evaluations in Japan should be prepared in accordance with JIS T 0993-1:2020, which is equivalent to ISO 10993-1:2018, with the applicable biological endpoints evaluated as appropriate.

Recent regulatory updates include the March 2025 revision of the basic principles for biological safety evaluation, PMDA’s review points published in June 2025, and further guidance issued in January 2026 concerning raw material changes and material descriptions.

Meanwhile, ISO 10993-1:2025 has been published. Although PMDA has not yet provided specific implementation guidance for the latest edition, manufacturers should continue to monitor Japanese regulatory developments when planning future biological safety evaluations.

1.2. Device Structure and Raw Material Descriptions

Clear and consistent device structure and material information is essential for PMDA’s biological safety review.

• Structure: A labeled diagram should be provided together with a table listing the name and function of each component, based on the engineering or design drawings. The function should describe the role of the component and its interaction with the patient.
• Raw materials: Components should follow the same order as the structure section, with body contact clearly indicated. Non-contact components generally require only a generic material name, while body-contacting components require more detailed specifications. Certain exceptions may apply to components such as adhesives, O-rings, and components with very brief contact.
• Material specification methods: PMDA recognizes three approaches: generic name with manufacturer and product information; generic name with a recognized standard such as JIS, ISO or ASTM; or generic name with chemical information and relevant physical or chemical properties.
• Supporting documents such as Material Safety Data Sheet (MDSD), Certificate of Analysis (CoA), and Technical Data Sheet should be available to support the submitted material information.

1.3. Biological Safety Evaluation

Biological safety evaluation is performed on the final product as part of the risk management process under ISO 14971, and following JIS T 0993-1:2020 (Identical to ISO 10993-1:2018). The process involves identifying biological hazards, estimating risks, determining whether testing is necessary, and implementing appropriate risk control measures where biological risks are identified.

1.4. GLP vs. ISO/IEC 17025

A key consideration is the distinction between Good Laboratory Practice (GLP) and ISO/IEC 17025.

GLP ensures the integrity and reliability of non-clinical safety data, covering areas such as study planning, personnel, raw data, quality assurance and archiving. ISO/IEC 17025, by comparison, demonstrates the technical competence of a testing laboratory but does not establish compliance with Japanese GLP requirements.

For applicable biological safety studies supporting PMDA approval applications, GLP compliance is required, and the use of non-GLP reports may affect the acceptance of submitted data.

1.5. Acceptance of Test Reports by PMDA

PMDA's acceptance of biological safety reports depends on the location and GLP status of the testing facility:

• Japanese laboratories with a valid PMDA GLP compliance certificate may be accepted without additional inspection.
• Laboratories in OECD Mutual Acceptance of Data (MAD) participating countries, such as Australia, Canada, France, Germany, Korea and the UK, may be accepted when holding a valid national GLP certificate.
• Laboratories in MAD provisional or non-MAD countries may be subject to additional review or a product-specific GLP inspection.

Manufacturers planning to use laboratories outside the OECD MAD framework should consider a PMDA General Consultation before submission to clarify potential inspection requirements.

1.6. GLP Inspections, Costs and Timeline

PMDA conducts three types of GLP inspection:

• Facility inspection: A voluntary facility-level assessment that may result in a GLP certificate valid for three years.
• Product-specific inspection: An assessment of an individual study, resulting in a pass or fail compliance decision rather than a general facility certificate.
• Unscheduled inspection: May be conducted where concerns arise regarding data integrity or regulatory compliance.

In addition to the product registration regulatory fee, the on-site inspection fee will also be charged for the GLP inspections. The inspection fees are JPY 3,203,600 for domestic inspections and JPY 3,545,600 for overseas inspections, excluding overseas travel expenses. Selecting an appropriately recognized GLP laboratory at the beginning of the testing strategy can help reduce potential regulatory delays and additional costs.

2. South Korea: Digital Medical Products Act & Digital Medical Devices

2.1. Regulatory Timeline and Scope

The Enforcement Rule of the Digital Medical Products Act was enacted on February 28, 2025, and first amended on January 23, 2026, introducing detailed procedures for digital medical devices and digital healthcare support devices.

Previously regulated under the Medical Devices Act or the In Vitro Diagnostic Medical Devices Act, digital medical devices are now subject to dedicated product codes, classification criteria, submission requirements, Digital GMP, and electronic-intrusion protection requirements.

The framework covers:

• Digital medical devices, including standalone software such as Software as a Medical Device (SaMD)
• Digital combination drugs
• Digital healthcare support devices

2.2. Determination of Digital Medical Device Status

Determination follows five key steps, assessing whether the product is a medical device or IVD, whether standalone software is involved, whether digital technology affects hardware control or operation, whether it affects data analysis or processing, and whether it is applied to an accessory.

Where the regulatory status remains unclear, manufacturers may request an official determination from MFDS, which we may take approximately 10 working days.

2.3. Classification and Regulatory Pathway

Classification considers the intended purpose, medical condition, target patient, product characteristics, and potential harm from malfunction or performance degradation.

For Digital Medical Products with critical or fatal conditions, examples include:

• Class 4: Treatment, rehabilitation, examination, diagnosis or medication support
• Class 3: Clinical management or guidance
• Class 2: Information provision or monitoring

Where multiple primary intended purposes apply, the higher applicable class prevails.

Class	Regulatory Pathway	Authority
Class 1	Notification	NIDS
Class 2	Certification	NIDS
Class 3	Approval	MFDS
Class 4	Approval	MFDS

2.4. Importation, K-GMP and Post-Market Surveillance

Commercial importation must be conducted through a licensed Korean importer, as foreign manufacturers cannot independently import digital medical devices in their own name.

K-GMP requirements should be assessed early in the regulatory strategy. Existing medical device GMP certificates may be recognized for digital medical devices under applicable transition arrangements, while remote inspections may be conducted for software where appropriate.

Following market entry, the Korean license holder or licensed importer is responsible for applicable post-market activities, including adverse event reporting and recall management. Digital medical devices additionally require appropriate controls for software version management, update history management, cybersecurity response and performance monitoring.

3. Key Takeaways

This webinar highlighted practical considerations for manufacturers seeking market access in Japan and South Korea. In Japan, particular attention should be paid to clear material documentation, appropriate biological safety evaluation, GLP compliance, and the acceptance of overseas test data.

In South Korea, manufacturers with software-enabled medical devices should assess the applicability of the new digital medical product framework at an early stage. Product classification, local importation arrangements, K-GMP, cybersecurity and lifecycle management should be considered as part of an integrated regulatory strategy.

For manufacturers planning to expand into Japan and South Korea, Qualtech can support strategic market entry planning, regulatory submissions, and navigation of local regulatory requirements. Contact us today to learn how we can support your product approval and market entry plans in Japan and South Korea.