CASE STUDY ON STRUCTURED PRODUCT LABELING (SPL) MANAGEMENT SERVICES
Geography: N/A
Type Service: N/A
Client Background/Client Requirements:
The client is a Leading global Medical Device manufacturer headquartered in Germany that manufactures technologies for diabetes management, including diagnostic and therapeutic devices. The company, active in the healthcare industry, also produces non-sterile and sterile lancing devices and lancets, which are used for blood capillary sampling in blood glucose monitoring. These Medical Devices are classified as Class B Medical Devices and are intended for professional use in Diagnostics and individual home-based diabetes care.
The client contacted Techsol Life Sciences to assist them in the Product registration of their medical devices for import and distribution to increase their Sales and Distribution in India. Throughout the CDSCO Import Registration process, Techsol Life Sciences assisted the client by ensuring that all regulatory guidelines were fulfilled on time
Project Objectives:
The objective of the project was to obtain regulatory approval for a Class B medical device categorized as a lancing device and lancets used for capillary blood sampling. These devices are intended for both professional use in Diagnostics and home-based diabetes self-monitoring by individuals. The key indications include blood glucose monitoring in patients with diabetes.
The regulatory goal was to obtain a Product Registration / Import License from the Central Drugs Standard Control Organization (CDSCO) under the Medical Devices Rules (MDR), 2017, by submitting a complete dossier through the SUGAM portal.
Regulatory goals :
- 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
Upon receiving the supporting documents as per MD-14 checklist Techsol Regulatory Team will prepare the dossier for compilation and submission to CDSCO. The regulatory dossier includes the following major components:
- 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)
The final submission was made via the SUGAM portal, with all applicable fees paid under Schedule II of MDR 2017
Challenges:
Post submission of the dossier following issues/ challenges are identified.
- 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.
- Submission of Specimen Batch Test Reports: During the initial submission, only generic batch data was provided, which is inadequate. CDSCO requires test reports for at least three consecutive batches covering all relevant parameters.
- Labeling Compliance with MDR 2017: Product labels were not in line with MDR 2017 requirements. Key information such as the importer/distributor name, manufacturer details, and expiry/manufacturing date were missing.
- Shelf-life Justification: Proper shelf-life justification is critical for maintaining product sterility, safety, and performance. Inadequate data or rationale may lead to regulatory concerns about device efficacy and patient safety.
- Digitally Signed Import License Application: The legal form (Form MD-14) must be digitally signed for submission via the SUGAM portal.
Project solutions:
Techsol played a crucial role in securing regulatory approval license for our client by streamlining the medical device registration process. By Employing a series of strategic actions focused on adherence to regulations, precise documentation, and responsive support. Techsol was able to facilitate a seamless registration process that not only minimized delays and risks but also exceeded client expectations.
- Techsol assisted the client in ensuring all critical documents i.e. Power of Attorney (PoA), Free Sale Certificate (FSC), CE Certificate, and Quality Management Certificates must be apostilled and notarized, preventing further delays and ensuring compliance with Indian MDR 2017.
- Techsol advised the client to perform standardized testing across three consecutive manufacturing batches of the lancets and glucometer strips. All test reports were verified by the manufacturer’s QA head as per the MDR 2017 requirements and submitted as part of the revised 3 consecutive manufacturing batches.
- Techsol Regulatory labelling experts performed the detailed label reviews and offer labeling remediation services to ensure full compliance with MDR 2017. Techsol also assist in the design and validation of compliant artwork and labeling requirements.
- Techsol informed the client’s global regulatory and R&D teams to collect real-time and accelerated stability data. A scientific justification letter was prepared outlining the rationale for the proposed shelf-life, referencing ISO 11607 (for sterile barrier systems) and ISO 10993 (for biocompatibility).
- Techsol ensured that the legal application form (Form MD-14) was digitally signed using a valid Digital Signature Certificate (DSC).
Project Achievements:
- Error-Free Documentation – Techsol ensured the submission included accurate and complete documentation, such as the MD-14 and MD-16 forms, meeting CDSCO’s stringent standards.
- On-Time Submission – Despite tight deadlines, Techsol managed to submit the application on time, meeting the client’s strategic timeline for market entry.
- Regulatory Approval and Compliance – The client received approval for their medical device registration within the anticipated timeframe, enabled by Techsol’s systematic and efficient approach.
Project Outcomes:
- The product registration / import license application approval MD-15 has received within the stipulated timelines
- Two rounds of CDSCO queries were effectively addressed, focusing on labeling compliance, additional data, shelf-life justification, and document formatting.
- Techsol Regulatory team has provided responses and maintained the proactive communication with the Regulatory authority.