Regulatory strategy
Initial assessment, device classification and development of the full approval roadmap in the country.
PMDA
Register your medical device in Japan.
Access the Japanese market through Notification (Class I), RCB (generic Class II/III) or PMDA PMA (new Class II/III/IV), with a dedicated DMAH.
Speak to a specialistThe authority
Pharmaceuticals and Medical Devices Agency
PMDA
Regulatory authority
Japan
The Japanese regulatory agency reviewing medicines, medical devices and cellular products under the Ministry of Health, Labour and Welfare (MHLW).
Visit the official websiteRegulatory framework
Main legislation and risk classes
| Class | Description | Examples |
|---|---|---|
| Class I | Extremely low risk, Todokede (notification) | Gauze, bandages, masks |
| Class II | Low risk. Generic devices: RCB review. New devices: PMDA PMA | Infusion pumps, diagnostic equipment |
| Class III | Moderate risk. Generic devices: RCB. New devices: PMDA PMA | Surgical equipment, external pacemakers |
| Class IV | High risk, mandatory PMDA PMA | Cardiac implants, valves, haemodialysis equipment |
Registration process
How we manage your project
- 01
DMAH1-2 months
Appoint a Japanese DMAH (Designated Marketing Authorization Holder)
- 02
Classification and JMDN3 weeks
Determine the class and JMDN code (Japan Medical Device Nomenclature)
- 03
PMD Act QMS4-6 months
Implement a QMS under the PMD Act Ministerial Ordinance
- 04
Technical dossier3-5 months
Prepare the submission in Japanese (certified translation)
- 05
RCB or PMDA reviewvariable
Generic devices through RCB (3 months). New devices through PMDA (6-36 months)
- 06
Marketing Authorisation1-2 months
MHLW issues the marketing authorisation
Total timeframeClass I: 1 week. Generic Class II/III: 3-6 months. New devices: 6-36 months
Local representativeDMAH (Designated Marketing Authorization Holder)
Approximate costUSD 20k-120k+ in fees depending on the pathway
Post-market
Post-approval obligations
| Area | Requirement |
|---|---|
| Surveillance | Adverse event reporting through the DMAH and periodic re-examination |
| Renewal | Indefinite validity, with re-examination every 4-7 years according to the class |
| Required QMS | ISO 13485 and PMD Act QMS Ministerial Ordinance |
How HSC helps
Japan with a dedicated DMAH and priority review for FDA-approved devices.
Technical dossier
Document preparation and translation in accordance with local requirements, including responses to deficiencies and requests.
Local representation
Acting directly as legal representative or recommending an authorised partner accredited by the authority.
Ongoing post-market support
Monitoring regulatory changes, renewals, surveillance and responses to authority audits.
Frequently asked questions
Questions about PMDA
Next step
Ready to start your project in Japan?
Speak to our team for an initial assessment of your product and the most efficient regulatory pathway.
Speak to a specialist