Blogs - CDSCO Medical Device Product Registration Approval Process and Classification in India

Understanding IVDR Classification: A Step-by-Step Guide for IVD Manufacturers
In vitro diagnostic medical devices (IVDs) have been an integral

Navigating UK MDR Post‑Market Surveillance: Practical Differences from EU MDR and Actionable Morulaa Tips
The UK’s post‑Brexit amendments to post‑market surveillance (PMS) bring new

Customs Clearance and Import of Medical Devices into India: What Overseas Manufacturers Must Know
Exporting medical devices, in vitro diagnostics, cosmetics, and other medical

Challenges Faced by Overseas Medical Device Manufacturers While Entering the Indian Market: Insights from Morulaa HealthTech on Navigating India’s Multi-Layered Regulatory Framework
For overseas medical device manufacturers in India, entering the Indian

CDSCO Medical Device Registration Process: 18 Top Questions Answered (2025 Update)
This user-friendly FAQ combines the latest updates from CDSCO (FAQ

Medical Device Amendments – Interventional Radiology
Introduction The Central Drugs Standard Control Organization (CDSCO) is responsible

Regulatory Consultancy for Medical Device Amendments in Cardiovascular Devices
Introduction The classification and approval of cardiovascular medical devices regulations

Essential Guide to Indian Medical Device Regulations for Manufacturers
Introduction India is one of the fastest-growing markets for medical

The Smart Way to Enter India’s Medical Device Market: Compliance, Imports & Distribution
Introduction The Indian medical device market is one of the

Indian MDR Amendments in Dermatological and Plastic Surgery
Indian MDR Amendments in Dermatological and Plastic Surgery India’s medical

Finding the Right Medical Device Distributor in India
Introduction The Indian medical device market is growing rapidly and

Medical Device Amendments for Devices Used in Physical Support
CDSCO Medical Device Registration: Amendments for Devices Used in Physical

Regulation and Classification of Class A (Self Notified) Medical Devices
Introduction: This article focuses on the classification and regulation of

Simplifying FDA Adverse Event Reporting: Everything You Need to Know About Form 3500A
1. Introduction to the FDA Form 3500A: FDA Form 3500A

Comprehensive Guide to Preparing a Plant Master File (PMF) for Medical Device Registration in India
In India, the Central Drugs Standard Control Organization (CDSCO) regulates
Morulaa HealthTech, founded by a family with a proud legacy of 130 years in business from Chennai, India, is a leader in the Indian medical device import regulatory compliance industry. Our family is well-known across the Food, Electronics, and Medical sectors, with a reputation for trust and excellence. Click on the video for a timeline of our history.
Morulaa HealthTech, founded by a family with a proud legacy of 130 years in business from Chennai, India, is a leader in the Indian medical device regulatory compliance industry. Our family is well-known across the Food, Electronics, and Medical sectors, with a reputation for trust and excellence. Click on the video for a timeline of our history.