ELTintern, Author at Medical Device Registration

Cosmetic Import License in Canada – Health Canada Guidelines

The Challenges in the FMCG Sector have grown over the years, especially for brands dealing with cosmetics and personal care products. Importing

Drug Registration in Brazil: Decoding ANVISA’s Regulatory

Registering drugs in Brazil means getting approval from ANVISA’s Regulatory (Agência Nacional de Vigilância Sanitária) so that a medicine can be legally

Brazil ANVISA Medical and IVD Device Registration

Brazil ANVISA Medical and IVD Device Registration explains how manufacturers and importers get legal approval to sell medical devices and in-vitro diagnostics

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 – 2025 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,