• To ensure full adherence to Medical Device regulatory standards, which includes MDR 2017, labeling,  risk assessment, and robust Post-Market Surveillance (PMS) strategy.
• To prepare a quality, submission-ready import license/ Product Registration dossier before submission to minimize the possibility of CDSCO queries.
• To obtain the approval of Import License / Product Registration within the stipulated timelines of the original application being submitted to Regulatory Authority

Techsol Approach :  

Our client’s medical devices were intended to be imported and distributed commercially in India from Germany. Techsol established a systematic approach for regulatory Strategy that was tailored to the project’s commercial timelines and CDSCO guidelines.

Phase 1: Project Initiation and Planning

• Kick-off Meeting: Upon contract signoff Techsol Project Manager will conduct a detailed kick-off meeting with the sponsor to align on scope, timelines, expectations, and responsibilities 
• Regulatory Strategy: Techsol Regulatory team will review the medical device details confirming its risk classification as per Indian MDR 2017 rules and develop the regulatory strategy for the Import License/ Product registration approval process in India. 
• Gap Assessment: Techsol Regulatory Team will provide the gap analysis checklist to the Sponsor, upon receiving documents from the sponsor, Techsol Regulatory team will review the source documents and confirm the classification of the device as per the Indian MDR 2017. If any deficiencies/gaps are identified same will be communicated to the sponsor 

Phase 2: Dossier Compilation and Submission

• Covering Letter
• Power of Attorney (POA)
• Copy of Whole Sale license / Manufacturing license
• Free Sale Certificate (FSC)
• Overseas Manufacturing Site Registration Certificate
• Quality Certificates (ISO 13485)
• CE Certificates (Product/Design/Type)
• Declaration of Conformity
• Site Master File (SMF) / Plant Master File (PMF)
• Device Master File (DMF)
• Instruction for use (IFU)

• Authentication of Regulatory Documents: Notarized, apostilled, or embassy-authenticated copies of documents (e.g., Power of Attorney, Free Sale Certificate, CE Certificate, Quality Certificate, and Manufacturing Site Certificate) were required but initially submitted without proper attestation, leading to delay in regulatory approval.

The manufacturer, a leading provider of ophthalmic surgical instruments, faced the challenge of consolidating multiple reusable instruments and devices under one state-of-the-art report to meet the stringent requirements set by the EU MDR 2017/745 regulations. Facing a shortage of available data, the manufacturer sought a comprehensive solution to tackle the challenge and ensure compliance.

Techsol Approach:  

• Holistic Data Collection and Analysis: The team implemented a robust data collection system to gather detailed information on each reusable instrument and device. This involved collaborating with various departments to ensure all relevant data was captured.
• Comprehensive Reporting: Extensive data analysis has been collected, systematically analyzed, and consolidated into a single cohesive report designed to meet the high standards of accuracy and detail required by the EU MDR regulations.
• Regulatory Alignment: Working closely with regulatory experts ensured that the report meets all specific standards and guidelines, with regular reviews and updates conducted to align the report with evolving regulatory requirements.

A pioneering medical device manufacturing company based in India, established in 2005, has been making significant strides in the healthcare industry and specialized in the development and manufacturing of advanced cardiovascular medical devices. The client had outsourced with Techsol Life Sciences to conduct a Clinical Investigation on the Transcatheter Heart Valves ensuring the regulatory standards (MDR 2017) and compliance.

Project Objective: 

The project’s scope is to conduct a clinical investigation on the Cardiac Valve – medical device to assess the safety, efficacy, and performance of the device in patients with severe aortic stenosis who were considered as high-risk or ineligible for surgical valve replacement.

The main key objective of the clinical investigation is to apply for a License/Approval for conducting a clinical investigation from the Health Authority (HA). Post approval received from the HA enrolment of patients with severe symptomatic aortic stenosis who met the criteria for TAVR according to current guidelines. Patients were assessed based on the inclusion criteria provided in the protocol/plan.

Techsol Approach:   

• Techsol Life Sciences provided support to the client for various activities related to their license Approval, Dossier preparation, Gap analysis of the documentation work, and Query management with the Health Authority.
• Additionally, Site coordination – PI, CRC & team, Clinical Trial Agreements, execution.
• Site Training, Site Compliance, Patient recruitment, Projections, Investigator letters, Site enrolment status report, Clinical monitoring plans, execution.
• Facilitating site audits. Inspections, monthly follow-ups. 
• Safety Reporting to Regulatory Agency (Health Authorities/IRB): Medical Monitoring review, AE/SUSARs reporting to IRB/Regulatory authorities.
• TMF setup, document upload, QC review, query management, and resolution & maintenance.
• Also, in recruiting the patients for the Clinical investigation.

A prominent international producer of Prosthodontic devices, renowned for its groundbreaking advancements in Dental health/hygiene, outsourced Techsol Lifesciences to craft clinical evaluation Report (CER) for their dental products and surgical devices, ensuring compliance with the EU MDR 2017/745 and TGA standards.

Project Objective: 

The aim was to develop and uphold essential components of the CE technical documentation for regulatory submissions of medical devices in the EU and TGA, including the Clinical Evaluation Report (CER), Clinical Evaluation Plan (CEP), and Literature Search Reports (LSR).
Techsol Approach:   

This involved conducting a thorough systematic literature review on the medical device and State-of-the-Art, assessing both non-clinical and clinical data provided by the manufacturer and to incorporate real-world evidence from adverse event databases. Furthermore, conducting a robust analysis of the devices’ safety, performance, and benefit-risk profile to ensure compliance along with General Safety and Performance Requirements outlined in the EU MDR.
Techsol provided support to the company for various activities related to their Class I, IIa, and IIb devices, including:

• Authoring CEPs, CERs, and LSRs to ensure compliance with EU MDR 2017/745.
• Evaluating the sufficiency of clinical data by analyzing product history, pre-clinical and clinical studies, complaints, adverse events, and literature.
• Swift processing and analysis of large volumes of data, facilitating rapid literature review.