Japan
Definition of medical devices
Devices or instruments, etc., used for the diagnosis, treatment, or prevention of diseases in humans or animals, or intended to affect the structure or function of the human or animal body (excluding regenerative medical products), as specified by Cabinet Order. (Article 2.4 Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act)))
Classification
| Type | Risk level |
| I | Low risk |
| II | Low to moderate risk |
| III | Moderate to high risk |
| IV | High risk |
Competent Authorities and Registration Process
Management agency:
- Ministry of Health, Labour and Welfare
- Pharmaceuticals and Medical Devices Agency
Registration process:
- Class I: Notification procedure
- Class II/III without certification standards: Submit application to a designed certification body (RCB) (certification)
- Class II/III without certification standards: Requires approval from MHLW via PMDA
- Class IV: Mandatory approval from MHLW
Options for registration applicant
Our Services
Registration service
Registration service
With a team of experts deeply knowledgeable in local regulatory requirements and extensive hands-on experience in medical device registration, MedNovum is willing to accompanie enterprises through every step — from document preparation to achieving results — ensuring a registration process that is accurate, efficient, and timely.
Marketing Authorization Holder (MAH) Service
Marketing Authorization Holder (MAH) Service
If enterprises are concerned about the cost of establishing a legal entity in Japan or wish to avoid granting exclusive distribution rights to a local partner, MedNovum offers a flexible and optimal solution. Through our trusted partner based in Japan, we provide MAH service, supporting enterprises in submitting registration applications as designated, while helping them maintain control over product management and market.
Regulatory Compliance Consulting Service
Regulatory Compliance Consulting Service
-Language barriers and the complexity of local regulations often pose challenges for enterprises entering new markets. Don’t worry — with MedNovum’s specialized consulting services, we ensure your compliance from the initial market entry stage through post-market activities.
MEDNOVUM
YOUR COMPREHENSIVE PARTNER IN THE MEDICAL DEVICES SECTOR
HUMAN RESOURCES
MedNovum brings together a team of experienced experts, including lawyers, pharmacists, and engineers who are extensively trained in the field of medical devices. With a strong knowledge base and deep understanding of legal regulations, technical procedures, and market requirements across multiple countries, we are confident in delivering comprehensive, accurate, and effective service solutions to every client. The combination of legal expertise and technical proficiency is what sets MedNovum apart, making us a trusted partner for many years.
ISO CERTIFICATE
Achieving the ISO 9001:2015 certification is an important milestone in MedNovum’s development journey. This achievement shows our strong commitment to maintaining high-quality services, meeting customer expectations, and strengthening MedNovum’s position in the medical device market.
NUMBER OF YEARS OF EXPERIENCE
With over 10 years of experience in the medical device industry, we understand the needs and challenges that businesses face. MedNovum is committed to providing professional, accurate, and reliable services – helping our clients save time, ensure regulatory compliance, and improve business performance.