What certifications are commonly required for first aid kits? (CE / ISO / FDA)

Common certifications include ISO13485 (medical device quality system), CE MDR (EU), FDA (USA), UKCA (UK), TGA (Australia), plus SGS/BSCI factory audits. Together they cover all major global markets.

Key points:

1. ISO 13485 - International quality management system for medical devices, recognized globally.

2. CE MDR - Mandatory for medical devices sold in the EU and EEA under Regulation (EU) 2017/745.

3. FDA & UKCA - FDA registration is required for the US market; UKCA applies to the UK after Brexit.

4. TGA & Audits - TGA covers Australia, while SGS/BSCI audits verify quality and social compliance.

We hold CE MDR, FDA and ISO13485 certifications and can provide full certificate documentation and online verification links for your target market.

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