CAPTIS™: MDD to MDR CER Remediation of a Standalone Software
Medical Device Registration Project in India, Bangladesh, Pakistan and Sri Lanka
Project Summary
A US medical device manufacturer was looking to introduce a new medical device and expand its market in India and neighboring countries (Class IIa and IIb). The manufacturer sought regulatory support in submission and obtaining approval to market these new products for business expansion.
The scope of Celegence activities was to manage all regulatory activities and ensure full regulatory compliance for medical device registration in India, Sri Lanka, Pakistan, and Bangladesh. The team was expected to work closely with local regulatory authorities to ensure the latest regulation requirements regarding product registration and maintenance were addressed. The team was also expected to engage in regular project monitoring, documentation filing, and timely status reporting.
Celegence Solution & Approach:
Celegence was awarded a contract to provide support in Medical Device Registration services and performing submission and obtaining approvals for new medical devices as per countries guidelines, including:
Highlights:
Preparation of submission dossier as per specific country regulatory guidelines with details of essential information on regulation, steps involved in the registration, supporting documents and other requirements for the listed countries
Maintain regulatory intelligence and work closely with the regulatory authority for support in Device registration
The initial information was provided by the Celegence delivery team with prior experience of working closely with Regulatory authorities. The checklist and other information were gathered as per the regulatory guidelines including the following:
Type of submission, classification of device, Product information
Local country specific dossier requirements
Country specific submission steps and related requirements
Strategy and timelines for submission
Project Achievements
On time quality-oriented dossier preparation and submission
Definition of detailed submissions steps to accelerate submission activities in the target markets
Minimization of registration filing gaps through a comprehensive analysis of registration requirements and related documents
Detailed monitoring of project schedule and proactively sharing project status to support the client’s strategic planning for device expansion
Capturing lessons learned through interactions with Health Authorities enabling better preparation of subsequent submissions and in turn accelerating the registration projects
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
Project Success
The output of the task was on-time preparation of the submission dossier for the assigned medical devices including the strategy. Key to the success of the project was our team’s integration, in house medical device experts, and direct contact with health authority representatives..
Find out more information
on Celegence’s Medical Device capabilities and support for medical device registration
Learn MoreOther Related Articles
25 Mar, 2025
Contact Us Today
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.
"*" indicates required fields