Regulatory Compliance

Bio-Robotix develops autonomous multi-robot systems for agricultural biosurveillance, medical disinfection, and national biosecurity infrastructure. This page summarises the regulatory and standards framework that governs our technology development, deployment practices, and data handling obligations. It is intended to provide transparency to prospective customers, partners, and regulators.

Bio-Robotix systems operate at the intersection of several regulated domains. The following frameworks are relevant to our technology and operations:

1.1 Unmanned Aerial Systems (UAS / Drone Regulations)

• UAE: General Civil Aviation Authority (GCAA) — CAAP 24 and associated UAS regulations govern drone operations in UAE airspace. Operators are required to register drones and obtain operational approvals for commercial and agricultural use.
• EU: EASA Regulation (EU) 2019/947 — categorises UAS operations (Open, Specific, Certified) and imposes corresponding safety and authorisation requirements.
• US: FAA Part 107 — governs small UAS commercial operations; waivers required for operations beyond visual line of sight (BVLOS) and swarm deployments.

1.2 Agricultural Inputs and Pesticide Application

• Drone-based application of pesticides, fungicides, or biological agents is subject to national agricultural authority approval in each deployment jurisdiction.
• Bio-Robotix systems are designed to be compatible with precision application requirements; customers are responsible for obtaining applicable pesticide application licences.

1.3 Medical Device and Disinfection Regulations

• UAE: Dubai Health Authority (DHA) and Department of Health Abu Dhabi (DoH) regulate medical devices and disinfection equipment used in healthcare settings.
• EU: Medical Device Regulation (MDR) 2017/745 may apply to autonomous disinfection systems used in clinical environments depending on classification.
• CAP (Cold Atmospheric Plasma) disinfection technology is subject to efficacy validation and, in some jurisdictions, biocidal product registration.

1.4 Biosafety and Biosecurity

• Systems deployed for national biosurveillance infrastructure may be subject to national biosecurity legislation and require government authorisation.
• Bio-Robotix engages with relevant national authorities during the pre-deployment phase to ensure compliance with applicable biosafety frameworks.

1.5 Data Protection and Privacy

• UAE PDPL: Federal Decree-Law No. 45 of 2021 on Personal Data Protection governs the collection and processing of personal data in the UAE.
• GDPR: Where Bio-Robotix processes data of EU residents, the General Data Protection Regulation applies.
• Sensor data collected by deployed systems (including environmental, aerial, and pathogen detection data) is handled in accordance with our Privacy Policy.

Bio-Robotix is building towards the following standards as part of its pre-commercial development roadmap. Certifications will be obtained prior to commercial deployment in each applicable jurisdiction.

Certain Bio-Robotix technologies may be subject to export control regulations, including the UAE Strategic Goods Regulation, the US Export Administration Regulations (EAR), and the EU Dual-Use Regulation. Bio-Robotix conducts export control screening as part of its customer onboarding process and will not supply systems to sanctioned entities or jurisdictions.

If you identify a security vulnerability or compliance concern related to Bio-Robotix systems or this website, please report it responsibly to [email protected]. We are committed to acknowledging reports within 5 business days and resolving confirmed issues in a timely manner.

For regulatory enquiries, compliance documentation requests, or pre-deployment authorisation discussions, please contact: