Which first aid products require medical device registration?

Kits containing sterile medical supplies (sterile dressings, tourniquets, disinfectants) used for medical purposes are classified as medical devices in most countries and need CE/FDA/TGA registration. Kits containing only simple non-sterile tools can be declared as general goods.

Key points:

1. Sterile supplies = device - Any sterile dressing, gauze or disinfectant makes the kit a medical device.

2. Simple tools only - Kits with scissors, bandages or non-sterile tools may be classified as general goods.

3. Classification service - We clearly classify every configuration and provide the correct declaration plan.

4. Regulatory support - We supply the technical documents needed for CE, FDA and TGA registration.

Tell us your target market and contents, and we will confirm the exact classification before you order.

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