Market Entry Japan – What Medical Technology Companies Need to Know Legally
Framework Conditions for Exporting to Japan
Japan remains an attractive target market for medical technology – however, the legal framework is complex and can be a stumbling block for many companies. Those looking to distribute their products in Japan should be aware of the following points:
1. Approval: Complex but Possible
Market access for medical technology products is based on the "Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices" (PMD Act). The approval process can take several months and varies in stringency depending on the risk class.
- Class 1 (low risk): Registration possible
- From Class 2: Examination by an accredited certification body required
Tip: There is an expedited procedure for innovative products – good chances for German developers.
2. MAH or DMAH: Essential for Approval
Only a Japanese company licensed as a Marketing Authorization Holder (MAH) or Designated MAH (DMAH) can officially approve and distribute a product.
- For foreign manufacturers, collaboration with a local partner is legally mandatory – and critical for business.
3. Quality Management: ISO 13485 Becomes Mandatory
As of March 2024, compliance with ISO standard 13485:2016 will be mandatory. The quality requirements are aligned with the "Ministerial Ordinance No. 169," which defines high standards for manufacturing and control.
4. Additional Regulations: Product-dependent
In addition to the PMD Act, other laws may also be relevant – such as the "Electric Appliance and Materials Safety Law" or the "Medical Treatment Law." Responsibilities lie, among others, with the PMDA (Pharmaceuticals and Medical Devices Agency).
5. Customs: No Trade Barrier, but...
The import of medical technology is duty-free. However, a Consumption Tax (comparable to sales tax) applies to the CIF value.
6. Tenders: Access Requires Documentation
Participation in public tenders requires reference projects and solid financial metrics. Private institutions have more leeway – however, a well-networked Japanese partner is advisable in any case.
Conclusion
The Japanese market is full of opportunities – but regulated. Legal certainty, partnership structures, and early preparation are crucial for market success.
Source: https://www.gtai.de/de/trade/japan-wirtschaft/medizintechnik