Blogs - Medical Device Registration and Regulatory Compliance Updates
HOW ANVISA’S NEW UDI REGULATIONS WILL AFFECT MEDICAL DEVICE MANUFACTURERS IN BRAZIL
In an effort to improve patient safety and streamline regulatory
REGULATORY RELIANCE PROGRAMS YOUR GLOBAL MEDICAL DEVICE APPROVALS
In today’s globalized medical device market, manufacturers face the challenge
BUREAU OF INDIAN STANDARDS NEW RULES PUBLISHED IN THE GAZETTE OF INDIA
The Ministry of Consumer Affairs, through the Bureau of Indian
TEAM NB POSITION PAPER PUBLISHED: WHAT IVD MANUFACTURERS NEED TO KNOW ABOUT COMBINATORIAL USE
MDR & IVDR Proposed Revisions Published on 02/03/2026 The proposed
Health Canada’s IMDRF ToC Guidance: What Medical‑Device Manufacturers Must Know (2025)
Health Canada has recently formalized the use of the IMDRF‑aligned
(ICMR–CDSCO) : Draft Protocol for Evaluating Diagnostic Kits – Respiratory Viruses, Malaria, Dengue, and Emerging Pathogens
India’s New IVD Rules: The Big Change Every Manufacturer Must
Healthcare Relief from GST Council : Lower Rates on Medical Devices and & Diagnostics
CDSCO Updates on GST Rate Changes: What Manufacturers, Importers, and
India Medical Device Regulations (MDR 2017) and CDSCO Regulatory Guide 2025 | Morulaa HealthTech
India’s Medical Device Regulations (MDR 2017), implemented by the Central
Impact of Trade Names on Medical Device Regulatory Compliance and Budgets in the EU, USA, and India: A Complete Guide
Table of Contents Introduction to Global Medical Device Regulations Medical
Understanding IVDR Classification: A Step-by-Step Guide for IVD Manufacturers
How Europe Now Regulates All Diagnostic Tests In vitro diagnostic
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 establishes Coordination Division, Tasked With Six Key Priority Areas
The Central Drugs Standard Control Organization (CDSCO) has established a
CDSCO Update: Auto-Generated MSC and NCC Certificates to Simplify Medical Device Regulatory Compliance in India
To strengthen medical device regulatory compliance in India, the Central
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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.