- Medical Device Registration 2026

UKCA Marking for Medical Devices After Brexit

Since the United Kingdom left the European Union (Brexit), the regulatory landscape for medical devices has changed. The UKCA mark (United Kingdom

Medical Device Import License in South Africa – SAHPRA Guidelines

In South Africa, medical devices and in vitro diagnostics (IVDs) are regulated by the South African Health Products Regulatory Authority (SAHPRA) under

How to Register Medical Devices in Australia with TGA?

If you want to sell or supply medical devices in Australia with TGA, you must first register them with the Therapeutic Goods

CE Marking Process for Medical Devices in Europe – 2026 Guide

If you want to sell medical devices in Europe, you must get the CE marking under the EU Medical Device Regulation (MDR,

ISO 13485 And ISO 9001: Which One Do Medical Device Companies Need?

When it comes to quality management, ISO certifications play a crucial role in building trust and ensuring safety in manufacturing. For medical

How to Apply for LMPC Certificate for Importing Medical Devices?

The LMPC Certificate for Importing Medical Devices is a mandatory compliance requirement under the Legal Metrology (Packaged Commodities) Rules, 2011, governed by

Japan PMDA Approval Process for Medical Devices

Japan PMDA approval process (Pharmaceuticals and Medical Devices Agency), under the Ministry of Health, Labour and Welfare (MHLW). The PMDA reviews, approves,

Story of Fake ISO Certificates

ISO certificates are issued to businesses that follow international quality, safety, and efficiency standards. They help companies build credibility, enter global markets,

Quality Management System (QMS) Upgrades

A Quality Management System (QMS) is a structured framework that helps organizations maintain quality in their products, services, and processes. Over time,

Is A Medical Device A Pharmaceutical Product?

The question “Is a medical device a pharmaceutical product?” is often confusing for manufacturers, importers, and even healthcare professionals. While both medical