Medical Device Regulatory Guides

Registering medical devices in a new market usually means a different authority, a different classification system and a different document set in every country. To make market entry planning easier, the regulatory support team at Gaoguan Medical prepared country-by-country guides covering registration pathways, import requirements and typical documentation for the markets below.

Start with the overview, then open the guide for your target market. Each guide explains who the regulator is, how the registration process works and which documents an importer or distributor must prepare.

All Regulatory Guides

• Medical Device Import & Registration Guides by Country
• Brazil ANVISA Registration for Medical Consumables
• Egypt EDA Medical Device Registration Guide
• EU MDR Requirements for Importing Medical Consumables
• India CDSCO Medical Device Registration Guide
• Indonesia Kemenkes Medical Device Registration (AKD/AKL)
• Mexico COFEPRIS Medical Device Registration
• Russia EAC Certification for Medical Devices
• Saudi Arabia SFDA Medical Device Registration
• Thailand FDA Medical Device Registration
• UAE Medical Device Registration (MOHAP) Guide
• UK Medical Device Registration: UKCA Mark & MHRA Guide
• Vietnam Medical Device Import Requirements
• Algeria Medical Device Import Requirements
• Chile ISP Medical Device Registration
• Colombia INVIMA Medical Device Registration
• Dominican Republic Medical Device Import Requirements
• Kazakhstan Medical Device Registration (EAEU Framework)
• Kenya PPB Medical Device Registration
• Malaysia MDA Medical Device Registration
• Morocco Medical Device Import Requirements
• Nigeria NAFDAC Medical Device Registration
• Pakistan DRAP Medical Device Registration
• Peru DIGEMID Medical Device Registration
• Philippines FDA Medical Device Registration
• South Africa SAHPRA Medical Device Registration
• Turkey TITCK Medical Device Registration
• Uzbekistan Medical Device Registration

Need Support for Your Market?

Besides these guides we support customers with product testing coordination, documentation and label review for target markets. Talk to our team about your market entry plan.