Japan is the third-largest medical device market in the world and has one of the most rigorous regulatory systems in Asia. The PMDA manages two distinct approval pathways โ shonin and ninsho โ and requires a Japanese Marketing Authorization Holder for all registrations. Our database indexes 130,000+ PMDA records.
Search Japan registrations โThe Pharmaceuticals and Medical Devices Agency โ PMDA โ is Japan's national regulatory authority for drugs, medical devices, and other health products. PMDA operates under the Pharmaceuticals and Medical Devices Act (PMDA Act), previously known as the Pharmaceutical Affairs Law. Japan's regulatory framework is widely considered one of the most thorough in the world, on par with the US FDA and EU regulatory systems.
Japan's medical device market is substantial โ approximately USD 17โ20 billion annually โ making it the third largest globally after the United States and China. For medical device companies with serious Asian ambitions, Japan is typically the highest-effort, highest-reward market.
Japan is unique among the major Asian markets in having two distinct regulatory pathways for medical devices:
Shonin (ๆฟ่ช) โ Ministerial approval, required for higher-risk Class III and Class IV devices. This is the more demanding pathway: a full technical review by the Ministry of Health, Labour and Welfare (MHLW) and PMDA, often requiring clinical data, and typically taking 18 months to 3+ years. For novel high-risk devices, shonin is mandatory.
Ninsho (่ช่จผ) โ Third-party certification, applicable to designated Class II devices and some Class III devices that fall under established product standards (the "designated controlled medical device" category). Certification is conducted by PMDA-registered third-party bodies rather than MHLW directly, making it somewhat faster โ typically 6โ12 months for complete submissions. Ninsho is available where Japanese standards (JIS or equivalent) exist for the device type.
In the PMDA public database, approvals and certifications appear with different reference number formats. Shonin numbers have an approval number structure; ninsho numbers use a certification number structure. Both appear in our database with type labeled clearly.
| Class | Risk Level | Pathway | Examples |
|---|---|---|---|
| Class I | Lowest | Jitai-todokede (self-declaration) | Tongue depressors, surgical instruments (non-powered), cotton gauze |
| Class II | Low-Moderate | Ninsho (third-party certification) | Blood pressure monitors, X-ray equipment, powered wheelchairs |
| Class III | Moderate-High | Ninsho or Shonin depending on type | Dialysis machines, orthopedic implants, high-frequency surgical units |
| Class IV | Highest | Shonin (ministerial approval) | Pacemakers, drug-eluting stents, implantable neurostimulators |
Japan's most important structural difference from other Asian markets: foreign companies cannot directly hold Japanese medical device approvals. All approvals and certifications must be held by a Marketing Authorization Holder (MAH) โ a Japanese legal entity that takes full regulatory, quality, and post-market surveillance responsibility for the device in Japan.
For most foreign manufacturers, this means either establishing a Japanese subsidiary (which requires significant investment) or partnering with a Japanese company that can serve as MAH. The MAH relationship has strategic implications โ the MAH controls the Japanese registration, and changing MAH is a complex regulatory process.
When you search Japan registration data, the MAH is the entity listed as the approval holder. Identifying the underlying OEM โ particularly for devices where the MAH is a general-purpose distributor rather than a manufacturer's subsidiary โ requires inference. We tag these cases clearly in our data.
Japan has historically required clinical data generated in Japanese patients for many high-risk device approvals, particularly where there are physiological or epidemiological differences between Japanese and Western populations relevant to device performance. This "Japan-specific clinical data" requirement has been a significant barrier for foreign manufacturers.
Recent regulatory reforms have relaxed this requirement somewhat, with PMDA increasingly accepting foreign clinical data for devices where the relevant patient populations are comparable. The specific requirements vary by device type โ work with a Japan-specialized regulatory consultant to understand what's needed for your product.
Our Japan dataset indexes PMDA approval and certification records with normalized company names, device classifications, and registration type (shonin vs. ninsho) clearly labeled. You can use this to:
130,000+ records. No Japanese-language portal navigation required. 50 free searches per month.
130,000+ records covering shonin approvals and ninsho certifications. Understand the competitive landscape before committing to Japan market entry.