Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
Regulatory Compliance Associates Inc. (RCA)
Pleasant Prairie, WI, Tampa, FL
Regulatory Compliance Associates (RCA) is a leading global provider of regulatory and compliance expert consulting services for life science companies. The company offers expertise in regulatory affairs, assessments and audits, agency response, preparation and remediation, and new product development support for medical devices, pharmaceuticals, and compounding pharmacies.
Emergo by UL
USA, Canada, Brazil, Australia, China, Hong Kong, Taiwan, India
A dedicated partner for medical device and IVD manufacturers, we offers deep local regulatory expertise through its offices in over 20 global locations. Services include product registration, human factors research, clinical strategy, and local in-country representation to ensure rapid, compliant market access worldwide.
December 20, 2025
Approximately 5 minutes
Comparison of Technical Documentation Requirements for Medical Devices
Original post by Selvaraj Kumar on LinkedIn
Medical device manufacturers must prepare technical documentation that demonstrates safety, performance, and regulatory compliance. While the objective is similar across jurisdictions, the structure and emphasis vary by regulatory framework.
This article compares documentation expectations under four major systems:
- CDSCO (India)
- ISO 13485
- EU MDR
- US FDA 21 CFR 820
1. CDSCO – Central Drugs Standard Control Organization (India)
Device Description
Detailed description of the medical device, including intended use, indications, and operating principles.
Technical Specifications
Engineering drawings, design specifications, materials, and performance characteristics.
Manufacturing Information
Manufacturing process flow, quality control procedures, and details of manufacturing facilities.
Risk Management
Risk analysis reports and documented risk management plans.
Biocompatibility
Biocompatibility test reports for patient-contacting materials.
Clinical Evaluation
Clinical evidence demonstrating safety and effectiveness.
Labeling and IFU
Device labels, packaging artwork, and Instructions for Use.
2. ISO 13485:2016 – Quality Management System
Quality Management System Documentation
Quality manual, policies, and standard operating procedures.
Design and Development Controls
Design inputs, outputs, design reviews, verification, and validation records.
Risk Management
Risk management documentation aligned with ISO 14971.
Product Realization
Production processes, process validation, and manufacturing controls.
CAPA
Corrective and Preventive Action procedures and records.
Post-Market Feedback
Complaint handling and feedback mechanisms.
Traceability
Traceability from raw materials to finished medical devices.
3. EU MDR – European Union Medical Device Regulation
General Device Information
Device description, intended purpose, classification, and UDI information.
Design and Manufacturing Information
Detailed design dossiers and manufacturing process documentation.
Risk Management
Comprehensive risk analysis, evaluation, and control measures throughout the lifecycle.
Product Verification and Validation
Pre-clinical testing, clinical evaluation reports, and validation evidence.
Post-Market Surveillance (PMS)
PMS plans, PMCF plans, and Periodic Safety Update Reports (PSUR).
Labeling and IFU
EU-compliant labeling, Instructions for Use, and Summary of Safety and Clinical Performance (SSCP).