We are proud to announce that the LELA 5600 has officially received regulatory certification from Japan's Pharmaceuticals and Medical Devices Agency (PMDA). This milestone clears the way for the LELA 5600 to be marketed and sold in Japan, one of the world's most demanding and quality-conscious medical device markets.

What This Means

PMDA certification confirms that the LELA 5600 meets Japan's rigorous standards for safety, performance, and quality. The approval process is widely regarded as one of the most thorough in the world, requiring extensive technical documentation, quality management system verification, and performance data review.

This achievement reflects the strength of the quality and regulatory infrastructure behind the LELA 5600, consistent with the standards that underpin our approvals in other markets worldwide.

Why It Matters for Our Partners

For dental practices and dealers in Japan, this certification means the LELA 5600 is now a fully compliant, market-ready product — backed by documentation that stands up to procurement and compliance review at any dental institution or clinic group in the country.

For our dealer and distribution network, PMDA certification removes one of the biggest barriers to entering the Japanese market: regulatory uncertainty. Partners can now move forward with confidence, knowing the LELA 5600 meets the full requirements set by Japan's regulatory authority.

What's Next

With PMDA certification secured, we are moving forward with plans for distribution partnerships and market launch activities across Japan.