Regulatory

A deliberate global regulatory strategy

Beyondmedicine treats regulatory clearance as core to the product, not an afterthought. Our strategy is sequenced by market, grounded in clinical evidence at every stage.

Medical Device Classification

Clickless is developed and documented as a software medical device, following applicable design controls and quality standards.

Evidence-First Submissions

Regulatory filings are built on clinical trial data, positioning each submission on clinical merit.

Market-by-Market Expansion

We pursue clearance sequentially, starting in Korea, then the United States, followed by Europe and Japan.

Timeline

Path to global availability

  1. Completed

    Korea — Digital therapeutic device approval

    Clickless has progressed through Korea's regulatory framework for digital therapeutic medical devices.

  2. In progress

    United States — FDA De Novo pathway

    Beyondmedicine is preparing a De Novo classification request to bring Clickless to the US market.

  3. Planned

    Europe — CE marking

    Future submission under the EU Medical Device Regulation (MDR) framework.

  4. Planned

    Japan — PMDA review

    Future submission to Japan's Pharmaceuticals and Medical Devices Agency.

Partner with us on regulatory strategy.

Speak with our regulatory affairs team about market-specific timelines and requirements.