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GMP Compliance Audit
19Jul 2024
admin

GMP Compliance Audit

GMP Compliance Audit Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards.  It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.  Good manufacturing practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes. Products must: be of consistent high quality. Certificate Th...
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12Jul 2024
EU, Regulations, Swiss, UK Cubicdesignz

UDI DI

UDI-DI On 5 May 2017, the EU published the new EU MDR 2017/745 and IVDR 2017/746 regulations in which they formally introduced the UDI system in the EU. The UDI comprises the following components The Basic UDI-DI is a technique introduced by the EU for linking medical devices to their regulatory documentation so that the model of the product can be uniquely identified throughout its entire lifecycle. The linked documentation may include the declaration of conformity, notified body certificates,...
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January 27, 2024 admin

Saudi Arabia

Medical Device Registration Saudi Arabia Ministry of Health:      Ministry of Health Regulatory Authority:           Saudi Food & Drug Authority (SFDA) Medical Device Regulation:           Medical Devices Interim Regulation Official Language:       Arabic Classification:     Class A, B, C & D Registration Process: Determine the device classification Appoint an Authorized Representative Prepare the application form and required documentation. Submit the...
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January 20, 2024 admin

Saudi Arabia

Saudi Arabia Saudi Arabia Medical Device Regulations Regulatory Authority: Medical Device Sector, Saudi Food & Drug Authority Link for MoH: https://www.moh.gov.sa/en/Pages/default.aspx Medical device definition: Means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article: Medical device A. Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of...
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Best company for Medical Device Registration
12Nov 2025
Blogs, Medical Device, Registrations, Regulations, Trending Now OMC Medical Limited

OMC Medical Limited – The Best Company for Medical Device Registration Worldwide

Medical device registration is one of the most critical steps in launching a healthcare product globally. Every market has its own set of regulations, documentation requirements, and compliance expectations. For manufacturers, this often means navigating a complex and time-consuming process before a product can legally reach hospitals, clinics, or patients. That’s where OMC Medical Limited comes in. Recognized as one of the best companies for medical device registration, OMC helps manufacturer...
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10Nov 2025
Blogs, Canada, Medical Device, Registrations, Trending Now OMC Medical Limited

MDEL vs MDL in Canada: What’s the Difference and Which One Do You Need? 

For any company planning to sell or distribute medical devices in Canada, understanding the country’s licensing framework is essential. Health Canada requires medical device companies to hold the appropriate licences — but two terms often create confusion: MDEL and MDL.  They might sound similar, but these two licences serve very different purposes. Knowing which one applies to your product or business model is the first step to compliance — and to entering the Canadian market smoothly.&n...
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Regulatory harmonization
07Nov 2025
Blogs, Medical Device, Registrations, Regulations, Trending Now OMC Medical Limited

How Regulatory Harmonization Could Speed Up Medical Device Approvals by 2026 

Getting a medical device approved in multiple countries can feel like navigating a maze — every region has its own rules, documentation format, and approval process. But that’s changing fast. By 2026, global regulatory harmonization is expected to simplify how medical devices reach markets around the world.  At OMC Medical, we help manufacturers get ahead of these changes. Whether you’re entering Canada, the UK, the Middle East, or Asia, understanding and preparing for harmonization now...
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Pharmaceutical product registration in Senegal
17Oct 2025
Blogs, Medical Device, Registrations, Regulations, Trending Now OMC Medical Limited

A Strategic Guide to Pharmaceutical Product Registration in Senegal by OMC Medical

Senegal represents a pivotal pharmaceutical market in West Africa. For pharmaceutical companies looking to introduce their medicines, understanding and complying with the regulations set by the National Agency for Health Safety (ANSSA) is the first and most critical step. OMC Medical, with its deep expertise in Pharma Registration Senegal, provides this strategic overview to help you prepare.  The Governing Body: ANSSA  ANSSA is the central regulatory authority responsible for ensuring the...
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Guide for class 3 imported products
17Oct 2025
Blogs, China, Medical Device, Registrations, Regulations, Trending Now OMC Medical Limited

Demystifying China’s Medical Device Registration Fees: A Guide for Class III and Imported Products 

Navigating the financial aspects of your medical device registration in China is as critical as the technical dossier. Understanding the NMPA’s fee structure for Class III medical devices and imported medical devices can prevent costly delays and ensure a smooth path to market. At Shanghai OMC Medical Technology, we guide our clients through every financial and regulatory step. This article breaks down the official “Implementation Rules for Medical Device Product Registration Fees...
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14Oct 2025
Blogs, China, Medical Device, Registrations, Regulations, Trending Now OMC Medical Limited

Navigating the NMPA Registration Fee: A Critical Step to Market Approval in China

Securing market approval for your drug or medical device from China’s National Medical Products Administration (NMPA) is a detailed process where every step counts. One of the most critical, yet sometimes overlooked, stages is the payment of the official NMPA registration fee.  A misstep here can halt your entire application, causing significant delays and financial loss. At Shanghai OMC Medical Technology, we ensure our clients navigate this phase seamlessly from our strategic base in Ch...
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