Global Medtech Registration System



LICENSALE.COM®はコンプライアンスデータを分析し、あらゆる市場における医療機器およびIVD デバイス登録プロセスを管理する機械学習を搭載しております。 冗長性を削減し、効率性を最適化そして専門家による介入を必要最低限に抑えることに成功しております。






Lower cost


一般的な医療機器登録のライフサイクルが12段階であるのに対し、LICENSALE.COMの独自技術を使用すればたったの5段階に減らすことができます。 Licensaleは過去の登録データを使用することで、次の登録に必要なプロセスを最小化します。 つまり、Licensaleを使用すればするほどより効率的で費用対効果の高い市場承認プロセスが可能となります。




登録申請書は、世界中の140以上の国にあるLICENSALEの認定代理店および資格保有会社を通じて規制当局に提出されます。 そして当局承認後、ライセンス取得となります!


複数の専門家による文書のチェックが行われます。それぞれの市場の要件を満たしているか確認をしていきます。 情報が不足している場合や変更が必要な場合は、すぐにお知らせします。




既存のコンプライアンス文書を関心のある国の登録要件と一致させます。 医療機器またはIVDデバイスの承認、更新、移転、または修正がいつまでに完了できるのかを算出致します。


Update your product approval history and compliance documents with LICENSALE.


Learn your specific medical device compliance requirements in other countries and what their Market Access Readiness Index (MARI%™) scores are for each market.


Match your existing compliance data with local registration requirements in your country of interest. Find out when your medical or IVD device approval, renewal, transfer or amendment will be completed.


Multiple experts will check your documents for compliance with local requirements for each market. You will be informed of any missing information or changes that need to take place.


Your registration application is submitted to the regulatory agency via LICENSALE’s Authorized Representative and License Holder offices in 125+ countries around the world. You are the owner of the license!





* Note: If you use your general ISP e-mail address, such as gmail, yahoo etc. your LinkedIn profile address is required to process your request.

Luminex Corporation

LICENSALE Client Luminex's Logo

“Arazy Group has been instrumental in the commercialization of our IVD medical devices. Their expertise has allowed our company to successfully obtain product approval and expand access to our technology in three new markets over the past three years, with three additional markets underway.”

OraSure Technologies, Inc.

“We have been using LICENSALE.COM for obtaining and maintaining our device licenses in global markets. This system is a great tool for registering products in all jurisdictions including those that do not have defined regulatory pathway. “

Visionsense Ltd.

LICENSALE Client Visionsense's Logo

“Arazy Group has guided us with quality management and registration for over 10 years, obtaining licenses for our devices in the USA, EU, and Canada, with more projects underway. The seamless relationship between our teams has enabled us to maintain our quality management system at a high level and our ongoing cooperation is very fruitful and constructive.” – Azi Ben-Yishai

SPD Swiss Precision Diagnostics GmbH

Licensale Client Swiss Precision Diagnostics' logo

“Advantages of working with Arazy Group include their expert knowledge of regulatory processes in many markets throughout the world and that they offer a dedicated Arazy Group client manager, acting as a single point of contact with whom we can discuss the progress of ongoing projects and raise specific questions or concerns.”

Hanin Medical

LICENSALE Client Hanin Medical Center's Logo

“We were very excited to receive our 510k clearance for the SAAD patient monitor months earlier than anticipated with Arazy Group. Arazy Group went above and beyond for this project and we are very happy with the result, which marks the first registration project of its kind in the USA and EU.” – Rudolf Holzhausen, PhD.

Elekta, United Kingdom

LICENSALE Client Elekta's Logo

“Arazy Group’s approach to regulatory affairs and goals with regards to emerging markets are wholly in line with Elekta’s long-term goals. We are able to approach new opportunities with confidence that we can find a solution to the challenge.”