Based on the target markets I’ve mentioned, we have 2 choices in both USA & UAE, to either launch as a medical device or as a wellness device. It makes far greater sense to launch as a wellness device due to the longer timelines and uncertainty surrounding medical device / FDA clearance.
However, we would need to be mindful of avoiding certain phrases that claim to diagnose, treat, screen for, or prevent diseases or medical conditions.
If we opt for the wellness route:
- We need to get a certain list of approvals that shouldn't take longer than 3 months.
- We should look to apply for FDA approval as soon as possible, as it’ll help us introduce some other features that can be obtained via the biomarkers we are tracking and can be major differentiators when compared to the competition.
List of Approvals (Non-FDA Compliance)(click to close & open)
USA (Non-FDA Wellness Route):
- FCC certification and SAR testing for Bluetooth/Wi-Fi (radio/RF compliance)
- Battery safety: UN 38.3 (transport), UL/IEC 62368-1 (consumer electronics)
- Biocompatibility testing (ISO 10993 irritation/sensitisation) for skin contact (strongly recommended)
- Ingress protection (IP67/IP68) if claiming waterproof/sweatproof
- Truthful, substantiated advertising (FTC compliance)
- Privacy and security: FTC Health Breach Notification Rule, state privacy laws (e.g., CA CPRA, WA MHMDA), clear user consent, encryption, breach notification plan
- E-waste and labelling: country of origin, importer details, warranty, care instructions
- No FDA registration, listing, or QMS required if you avoid medical claims
UAE (Wellness Device Route):
- TDRA type approval for wireless/Bluetooth/Wi-Fi (telecom/RF compliance)
- Electrical safety: IEC/UL 62368-1; Certificate of Conformity (often via ESMA/ECAS)
- UAE RoHS (hazardous substances) compliance, ECAS certificate
- Battery safety: UN 38.3 for lithium cells/packs
- Biocompatibility (ISO 10993) for skin contact (recommended)
- Ingress protection (IP67/IP68) if claiming waterproof
- Bilingual labelling (Arabic/English), importer details, warranty, safety info
- Privacy and data protection: PDPL (Federal Law No. 45/2021), consent, data minimisation, secure storage
- No MOHAP (medical device) registration needed if you avoid medical claims
What we must avoid in both cases:
- Any claims or implicit claims to diagnose, treat, screen for, or prevent diseases/medical conditions
- Marketing or implying the device provides medical advice, replaces medical devices, or is for use in managing health conditions
- Use of "medical," "diagnostic," "therapy," or similar terms in product copy, packaging, or advertising
- Any unsubstantiated or misleading performance/safety claims
- Claims about use for children or vulnerable populations without proper compliance