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

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

Guide to Choosing Medical Device Distributor and Regulatory Consultants in India
Entering the Indian medical device market requires patience and long-term

Make in India Public Procurement Order 2017 Boosts Industry
On July 19, 2024, the Department for Promotion of Industry

Legal Meteorology Requirements, Medical Devices, India
Legal Metrology Compliance Are you a manufacturer or importer of

Testing and Evaluation for Medical Devices/ IVD’s , India
On May 29, 2024, the Central Drugs Standard Control Organisation

India Drug Barcode New Regulations: Enhancing Safety and Compliance
In a significant move to enhance drug safety and combat

E-Waste Management for Medical Devices in India
E-Waste Management for Medical Devices in India is crucial for

Medical Device Labeling Requirements in India
Labeling for medical devices in India is very important for
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.