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

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

Preparing a Device Master File (DMF) as per the Medical Device Rules, 2017: A Guide by Morulaa HealthTech
Morulaa HealthTech, as the leading consultant in India for medical

MD-14 Form Application: Sugam Portal Simple Guide for Medical Devices (CDSCO)
1. Why is the MD-14 Legal form a critical part

Step-by-Step CDSCO Guide to Predicate Table Creation for Medical Device Registration in India
One of the critical documents that determine the success of

CDSCO Registration Guide: Steps to Prepare Your Medical Device Dossier
Navigating the CDSCO registration process for medical devices in India

Navigating India’s Medical Device Market: Key Insights for Global Manufacturers
The growth story of India is well-known while manufacturers understand
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.