CAPTIS™: MDD to MDR CER Remediation of a Standalone Software
New Medical Devices Registration in ROW Countries
Project Summary
An EU medical device manufacturer was looking to expand its market beyond Europe for a new medical device (Class IIb). The manufacturer was looking for Regulatory Intelligence for 48+ countries to market this new product leveraging their CE mark approval in the EU.
The scope of Celegence activities was to provide advisory consulting through a comprehensive Regulatory Intelligence (RI) report covering registration requirements for 48 Rest of the World (ROW) markets related to a Class IIB (EU) Medical Device. This report would be used by the client to define their global regulatory submission and product launch strategy. The Celegence team would also monitor changes to the global as well as local country requirements and provide updated Regulatory Intelligence report on an ongoing basis to ensure up-to-date information.
Celegence Solution & Approach:
Celegence was awarded a contract to provide Regulatory Intelligence services detailing information required for obtaining registration certificate in 48 countries, including:
Highlights:
Preparation of comprehensive RI report with details of essential information on regulation, steps involved in the registration, supporting documents and other requirements for the listed countries
Provision of updates to the report every 6 months detailing the changes or updated regulatory requirements in all 48 countries
Answers to product lifecycle management related queries for emerging markets
The initial research was done by the offshore Celegence team by using secondary research methods. The information was gathered using public regulatory sources for each market including the following:
Regulatory agency websites, Regulatory Laws, Legislations or Policies, Guidance documents
Concept Papers
Drug Authorities Presentations
For countries or regions where the data was not accessible from initial research, the following approach was taken:
Opinion and advice from Celegence’s internal operations team including publishing, submission, and clinical professionals
Input from local Subject Matter Experts with experience registering devices in the concerned countries
Email correspondence, and telephone enquiries with the concerned Health authorities and local agent
Project Achievements
The information obtained in the report will be incorporated in Celegence’s Regulatory Intelligence technology platform, SRI (Simplified Regulatory Intelligence), which will be launched in Q4 2019. SRI will provide clients with the required inputs for defining their regulatory submission strategy, along with the capability to share information related to various process areas such as quality, labeling, and pharmacovigilance. This collaborative and innovative technology platform will also allow our clients to gather and maintain knowledge obtained during the registration process, interact with local subject matter experts, and receive ongoing updates about local country requirements from the Celegence team.
Provision of the most current and evidence-based information on the nature of existing device regulations in the target markets
The similarities and differences in the target markets for quick decisions or risk-benefit analysis
Clear submissions steps to accelerate submission activities in the target markets
Minimization of filing gaps through comprehensive analysis of registration requirements and related documents
Timeline information on submission and approvals to support the client’s strategic planning for device expansion
Coverage of market entry strategies that could be implemented to minimize delays
Comprehensive and accurate registration requirements including steps, fees, and average timeline in order to inform regulatory strategy and minimize potential delays
Reduction of operational cost
Ongoing compliance improvement with access to Celegence’s regulatory expert network
Ability to digest only the useful and necessary information rather than a ‘data dump’ through simple and comprehensive RI report format
Consistent information across countries with an established report format for future expansion
Find out more information
on Celegence’s Regulatory Intelligence capabilities and support for medical device registration
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25 Mar, 2025
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