Market Insider

Medtech registration just became mobile

The launch of LICENSALE.COM by the Arazy Group in global medtech registration system was commenced in the year 2013. The company took a strong lead for providing offerings for advanced registrations and license management technology solutions, designed specifically for the medical and IVD devices industry. LICENSALE delivered thousands of new product registrations, amendments, renewals, and transfer of licenses over the past seven years. From the past satisfactory results, Arazy Group developed the next generation in Medtech registration and license management software that are LICENSALE® 2.0, REGISLATE® and the EUDAMEDtech© system    

Key takeaways

Using LICENSALE.COM, a pioneer in global radiation therapy, Elekta AB announced about receiving approval for 75 different products in 16 different countries in just 12 months.

OraSure Technologies product received approval from LICENSALE.COM for OraQuick HIV self-test.

Market Dynamics

Traditional FDA clearance 510(k) v/s LICENSALE

Arazy Group's regulatory online platform, LICENSALE, simplifies and expedites compliance process and safely stores and shares compliance information with authorities, notified bodies, and distributors. Using LICENSALE, it assists by providing complete guidance, documentation, and settlement for noncompliance. When compared with FDA, the manufacturers must issue an Emergency Use Authorization (EUA) for medical devices in the industry. The documentation process is tedious for getting product approval from FDA that impacts the overall revenue of the global market. When it comes to LICENSALE.COM, the expected approval dates for the company's registration will get continually updates coupled with license expiry details on the same platform.

Fast product clearance enhancement for offering service globally

In August 2020, Arazy Group announced receiving fastest traditional FDA clearance from FDA new “Triage Quick” Program. The traditional submission, that was sent for Triage Quick program was reviewed in July 2020 and received clearance 18 days later. Due to this, global Medtech registration platform, a variety of medical therapeutic and diagnostic products, including software was successfully cleared.

LICENSALE is now available on mobile

LICENSALE Mobile is now available on the app store and Google play. Through mobile incorporation manufacturers product portfolio real time marketing is feasible involving estimated approval dates. The option to check and review documents from regulatory experts is another option that is well suited on this platform. Additionally, the progress of the projects can be tracked by checking the application performance progress from anywhere at any time. Moreover, included option to conveniently respond to both the teams internal as well as regulatory experts on one go.

Regulatory scenario

2014 has grabbed strong attention for LICENSALE.COM. Hanin Medical’s SAAD patient monitor, the first Saudi designed and manufactured device was cleared for sale in the European Union (EU) and USA that received 510 (k) clearances in August 2014. Since the medical device user fee and modernization act (MDUFMA 2) was reapproved in October 2013, Arazy Group has applied its innovative LICENSALE.COM™ process to new 510(k) submissions, resulting in zero Not Substantially Equivalent (NSE) letters (100% of 510(k) submissions were cleared). The review times have been reduced since the incorporation of LICENSALE.COM. The average time of the review is set between 90-110 days several of the clearance letters issued in the last 16 months have been completed in only 60-70 days. VisionSense’s VS3 Stereoscopic High Definition Vision System traditional 510(k) application was sent on April 2014 that was cleared within 67 days. This is achieved through the process that has reinvented the review clock from pausing by eliminating Refuse to Accept (RTA) deficiencies while screening and keeping substantial review questions to minimum (in some cases avoid altogether). This offers FDA reviewers to meet the set target and improve performance goals and clients to get the product service faster. The LICENSALE.COM achieves the set target by incorporation of innovative and proprietary design, constructed over a period of over four years by regulatory experts. Additionally, some delays were avoided altogether through innovative submission practices and expert knowledge of regulations. For instance, when the material supplier for the FDA Class 3 Ameco hemodialysis catheter decided to change the formulation of the raw materials, LICENSALE.COM was able to submit the modification report as a special 510 (k) notification, resulting in recovering clearance in only 30 days. When compared with traditional process, review time might have gained a period of 90 days not involving time required for preparation the submission and addressing all review cycles.

Segmental Outlook

Medtech registration app market is based on type and application. By type, the market is bifurcated into software and services. Based on application, the market is classified as medical devices and in-vitro diagnostic devices (IVD).

Based on type, software segment will record largest revenue share in the global Medtech registration app market. LICENSALE is the most advanced system for Medtech regulatory affairs in the global market. The newest version of LICENSALE involves ready-to-use medical and IVD device registration through mobile apps and smart phones. A unique GR-MAP technology that supports integrated software assists in market analysis & planning, real time registration management and reporting. The process starts with proprietary technology that incorporates standard medical device registration life cycle that is reduced to 5 steps through software.

Regional Overview

North America is anticipated to dominate the global Medtech registration app market. Integration of advanced technologies, high adoption of advanced tech advancement by prominent players, and presence of key players involved in introducing new products for benefit of the patient. Additionally, fast product approvals by the USFDA for the benefit of the manufacturers and introducing new products in the global market for service offerings are the factors that contribute to the fullest for regional market growth of Medtech registration app.

Europe is expected to be the second largest region after North America for medtech registration app market regionally.

Competitive Landscape

Key companies profiled in this report involve Arazy Group, Elekta, OraSure Technologies, Inc., Luminex Corporation, Hanin Medical, Visionsense Ltd., and among others.

Market Segmentation

Market By Type

Software

Services

Market By Application

Medical Devices

In-Vitro Diagnostic Device (Ivd)

Market By Geography

North America

• U.S.
• Canada

Europe

• U.K.
• Germany
• France
• Spain
• Rest of Europe

Asia-Pacific

• China
• Japan
• India
• Australia
• South Korea
• Rest of Asia-Pacific

Latin America

• Brazil
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC
• South Africa
• Rest of Middle East & Africa