While advanced medical and diagnostic products become available for patients around the world every day, government regulatory agencies are faced with the complex task of implementing a rigorous approval process that can safely bring new medical technologies into their domestic market without delaying access to often essential medical care.
REGISLATE™ completes the infrastructure required for the operation of a professional and efficient government regulatory agency. Within months, your regulatory agency can deliver a simple and effective approval process that complies with those of leading agencies worldwide and be supported by the most up-to-date global regulatory intelligence, assuring that only medical devices of the highest standards are being offered to the public.
HOW DOES IT WORK?
The REGISLATE™ system works seamlessly in seven steps:
- Set-up your regulatory requirements and customized controls online;
- Direct manufacturers to find their product requirement information and upload supporting documents;
- Review uploaded documents, verify that current regulatory standards are satisfied, and communicate discrepancies to the manufacturer if required;
- Collect review charges and license fees;
- Issue market clearances or approvals as applicable;
- Maintain and modify current requirements accordingly;
- Renew licenses periodically by repeating the process above.
START INTELLIGENT REQUIREMENT MANAGEMENT
Define and implement your own organization’s regulatory requirements in the cloud for each and every product type or product class, allowing for instant updates and easy changes to your regulatory submission process. By defining your requirements, REGISLATE™'s advanced system enables your organization to publish clear guidelines, increasing transparency and the speed of application review. If you would like to refer to the standards implemented by other international organizations, that information is readily available for your reference.
STREAMLINE YOUR REVIEW PROCESS WITH REGISLATE™
Once you have determined the requirements for applications, applicants can access the system through a dedicated applicant portal and submit their documents and fees directly into the accessible cloud-based system. Applicants are presented with a detailed presentation of the requirements including descriptions, document samples, guidelines, official forms, and references to international compliance standards for maximum clarity and efficiency.
REGISLATE™ matches requirements to documents for efficient review. Direct communication with applicants through their portal during pre-market product review and post-market approval provides further control and oversight through the complete device life cycle, its use and traceability.
DESIGN A FLEXIBLE SYSTEM WITH REGISLATE™ FOR EASY CHANGES
If you introduce new requirements or modify existing ones, those changes are easily and instantly implemented throughout your secure REGISLATE™ system, ensuring that both the applicants and your own team is up-to-date through immediate notifications. The same features apply to new modules, particularly with post-market surveillance, such as traceability, vigilance reporting, annual reports, and post-marketing clinical studies. Should there be a need for a recall, affected products already registered in your system are instantly flagged and communicated to the manufacturer.
TAKE ADVANTAGE OF
Not only are documents matched with your own agency’s reviewers through their dedicated expert portals, but REGISLATE™ users can introduce any external experts to assist and expedite the review process. REGISLATE™ can also recommend an expert (no matter how specific the requirements) within the organization or through Arazy Group’s WORKNET™ network, to review the file with experience and speed. You can securely assign experts to files or single documents with full permissions control.
INTEGRATE WITH OTHER
ARAZY GROUP SERVICES
Hundreds of manufacturers use LICENSALE.COM™, the online product submission portal, to submit applications around the world. Product compliance information uploaded by manufacturers to the regulatory agencies of other countries is available online, simplifying and accelerating the performance of your institution. Documents uploaded to LICENSALE.COM™ are matched seamlessly with the product compliance criteria set up into your REGISLATE™ system. You can benefit from previous professional reviews of the documents for those products conducted by other agencies and by other experts, further simplifying and expediting your own review process.
BUILD SUSTAINABLE PRACTICES
The ultimate flexibility of REGISLATE™ accommodates the unique needs of your organization and builds a system that grows with your organization. REGISLATE™ is designed to manage the entire product life-cycle, including product changes and license renewals. Throughout the process, affordable fees are easily passed down to applicants via a user-fee pricing model, making REGISLATE™ a cost-effective solution for any regulatory body. Unlimited archives and built-in version controls ensure well-kept records throughout your organization.
Do you have questions about REGISLATE™ Government? Fill out the form below and an Arazy Group representative will contact you promptly.