Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm
  • info@omcmedical.co.uk

Get In Touch:

Get In Touch:

  • info@omcmedical.co.uk
Youtube Linkedin Facebook Instagram
Call Us Now:
+44 2080667260 sales@omcmedical.com

Blogs

Home
Blog Standard
Blogs
Medical Device Grouping in India
19May 2025
Blogs, CDSCO, India, Medical Device, Trending Now OMC Medical Limited

Medical Device Grouping in India 

As India improves its rules for medical devices, it’s important to know how products are grouped when they are registered. The Central Drugs Standard Control Organization (CDSCO) has created clear guidelines for grouping medical devices. This helps make the submission process easier, avoids repeating work, and makes the rules clearer. Grouping allows manufacturers to organize similar products better, making the approval process smoother and more predictable. What is Medical Device Grouping in...
Read More
Why You Need an Authorized Indian Agent for CDSCO Registration
19May 2025
Blogs, CDSCO, India, Medical Device, Trending Now OMC Medical Limited

Why You Need an Authorized Indian Agent for CDSCO Registration

Entering the Indian market with medical devices requires a clear understanding of the CDSCO registration process. One of the key requirements for foreign manufacturers is to appoint an Authorized Indian Agent (IAA). But why is this step so crucial, and how can it streamline your product’s path to market? In this blog, we’ll walk you through why you need an Authorized Indian Agent for Indian medical device registration, what they do, and how partnering with an experienced agent can simplify y...
Read More
Challenges in CDSCO registration in India
16May 2025
Blogs, CDSCO, India, Medical Device, Trending Now OMC Medical Limited

6 Challenges in CDSCO Registration & How OMC Solves Them

Getting medical devices approved for the Indian market involves more than just paperwork. CDSCO follows strict guidelines, and if you’re not familiar with how it works, the process can feel overwhelming. Whether you’re a local manufacturer or a foreign company trying to import your product into India, there are common hurdles you’re likely to face. In this blog, we break down the main challenges in CDSCO registration—and show how OMC Medical can help you solve them, step by step....
Read More
Post Market surveillance (PMS) requirements in SFDA
13May 2025
Blogs, Saudi Arabia, SFDA, Trending Now OMC Medical Limited

8 Requirements for Post-Market Surveillance of Medical Devices in Saudi Arabia

Post-market surveillance (PMS) plays a critical role in maintaining the safety, quality, and performance of medical devices available in Saudi Arabia. The Saudi Food and Drug Authority (SFDA) enforces clear and structured requirements under the “Medical Devices – Post Market Surveillance Requirements” (MDS-REQ 11) to ensure ongoing monitoring once devices are placed on the market. This article outlines the key PMS requirements that manufacturers, authorized representatives, importe...
Read More
CDSCO-Fee-License-Fee-for-Medical-Device-Registration
12May 2025
Blogs, CDSCO, Medical Device, Trending Now OMC Medical Limited

CDSCO Fee & License Fee for Medical Device Registration

Entering the Indian medical device market requires compliance with the Central Drugs Standard Control Organisation (CDSCO) regulations. A crucial aspect of this compliance is understanding the associated registration and import license fees. These fees vary based on the classification of your device and the nature of your operations. This guide provides a detailed overview to help you navigate the financial aspects of the regulatory process. CDSCO Registration Fees for Medical Devices The regist...
Read More
08May 2025
Regulations, Blogs, CDSCO, India, Trending Now admin

Medical Device Registration Process CDSCO

If you plan to sell medical devices in India—either as a local manufacturer or a foreign company—you must register your product with the Central Drugs Standard Control Organisation (CDSCO). CDSCO is India’s national regulatory authority responsible for ensuring the safety, quality, and performance of medical devices and drugs. In this guide, we explain the CDSCO registration process step by step, including recent updates in 2025, required documents, timelines, and key responsibilities for...
Read More
Challenges in UAE medical device registration
30Apr 2025
Trending Now, Blogs, UAE OMC Medical Limited

Top 7 Challenges in UAE Medical Device Registration(and Solutions)

You’ve got a medical device ready for the UAE market—everything from quality certifications to technical documentation is in place. But just as you start the registration process, the real challenge begins.Suddenly, you’re navigating a sea of forms, portals, and changing regulations. The process feels unclear, the requirements keep shifting, and your timeline starts slipping. Sound familiar? You’re not alone. Many manufacturers and importers face similar frustrations when dealing wit...
Read More
2024 UK post-market surveillance (PMS) amendments
24Apr 2025
Trending Now, Blogs, Medical Device, UK OMC Medical Limited

What the 2024 UK Medical Device PMS Amendments Mean for Manufacturers?  

In a significant move towards improving patient safety and product oversight, the UK has introduced new post-market surveillance (PMS) requirements under the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. These regulations, effective from 16 June 2025, amend the UK Medical Devices Regulations 2002 by adding a new Part 4A, which outlines comprehensive PMS requirements for medical devices, including in vitro diagnostic (IVD) devices and active...
Read More
eifu guidelines for medical devices in saudi
21Apr 2025
Trending Now, Blogs, Saudi Arabia, SFDA admin

e-IFU Guidelines for Medical Devices in Saudi Arabia 

Imagine you’re a healthcare professional in Riyadh, mid-procedure, and you urgently need access to a device’s instructions. Instead of flipping through a bulky printed manual, you scan a QR code on the device. Within seconds, the most up-to-date instructions appear on your tablet. That’s the power and convenience of Electronic Instructions for Use (e-IFU). Not long ago, when someone bought a medical device, it came with a thick instruction manual—usually in multiple languages, pa...
Read More
SFDA Fees for Medical Devices 
16Apr 2025
Blogs, Medical Device, SFDA, Trending Now admin

SFDA Fees for Medical Devices

Navigating the SFDA fees for medical devices is critical to achieving compliance and entering the Saudi Arabian market. The Saudi Food and Drug Authority (SFDA) outlines specific fee structures and timelines based on device classifications, application updates, and authorized representative requirements.   Timelines, and Requirements for SFDA Fees for Medical Devices 1. Device Classification and Fees  SFDA fees for medical device marketing authorization (MDMA) vary by risk classif...
Read More

Enquiry Now

    This will close in 0 seconds