Case Study: Regulatory Intelligence Services to Support New Medical Device Registration in ROW Countries

Background – Client Needs:

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 client faced the following challenges:

  • Development of a global product launch strategy without complete and practical knowledge of global requirements as well as country specific requirements

  • Understanding the important local requirements like time to market, fee details, local testing and clinical evaluation requirements and local classification in markets with little or no public information available

  • Regulatory standards differing and continuously evolving from country to country

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.

Project Initiation & Key Objectives:

The client chose to leverage Celegence’s team of regulatory experts to support this regulatory intelligence project based on our extensive expert network and ability to maintain the report in a cost-efficient manner.

The client’s objectives involved realising the following business benefits via their outsourcing strategy:

  • Input for the global product launch strategy for a new medical device and acceleration of the registration process

  • Significant reduction of operational cost for initial registration as well as maintenance

  • Inputs on ongoing maintenance of Regulatory Compliance

Celegence Solution & Approach:

Celegence was awarded a contract to provide Regulatory Intelligence services detailing information required for obtaining registration certificate in 48 countries, including:

  • 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

The output of the research and analysis was a comprehensive Regulatory Intelligence report with the required information for registration, including local classification, clinical trial requirements, import/export requirements, and local representative requirements. The report also included detailed steps for registering the device leveraging the CE mark and hence finding accelerated registration pathways.

Key to the success of the project was our team’s integration of local experts, in house medical device experts, and direct contact with health authorities to create a comprehensive report. In addition, most of the regulations, guidance documents and information were only available in local languages, so our multilingual technical experts helped to assess the information in English.

Key Project Achievements

  • 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

Celegence delivered the following value and business impact to the client:

  • 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

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.

Find out more information on Celegence’s Regulatory Intelligence capabilities and support for medical device registration

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