US FDA Registration — Smart Technology

Smart Technology is committed to meeting the regulatory expectations of the United States Food and Drug Administration (US FDA) for medical device manufacturers. As a global producer of ophthalmic and surgical products, we ensure that our manufacturing processes, quality systems, and product documentation align with the requirements outlined under 21 CFR Part 820 (Quality System Regulation) and related FDA guidance documents.

Our advanced manufacturing facility — featuring ISO 10000 clean room environments, robotic assembly, and specialized medical‑grade packaging systems — is designed to support FDA‑compliant production of Class I and Class II medical devices. Every stage of development, from material selection to final packaging, follows strict quality controls to ensure safety, performance, and traceability.

FDA Compliance Framework

Smart Technology operates under a regulatory framework that includes:

  • Quality System Regulation (QSR) – 21 CFR 820
    Ensures design controls, process validation, CAPA, complaint handling, and documentation integrity.

  • Establishment Registration & Device Listing (21 CFR 807)
    Required for manufacturers distributing medical devices in the United States.

  • Labeling Compliance (21 CFR 801)
    Ensures all product labels, IFUs, and packaging meet FDA requirements for clarity, safety, and proper use.

  • Medical Device Reporting (21 CFR 803)
    Ensures timely reporting of adverse events, should they occur.

  • UDI (Unique Device Identification) Readiness
    Supports traceability and post‑market surveillance for devices distributed in the U.S.

Commitment to US Market Access

Smart Technology’s global distribution network includes the United States, and our regulatory team ensures that all products intended for U.S. distribution meet applicable FDA requirements. This includes:

  • Maintaining FDA‑compliant manufacturing documentation
  • Supporting importers and distributors with regulatory paperwork
  • Providing device technical files, sterilization validation (where applicable), and risk‑management documentation
  • Ensuring packaging and labeling meet U.S. standards

Our surgeon‑led design philosophy ensures that every product — from eye conformers to protective shields and orbital implants — is engineered with patient safety and regulatory compliance at its core.

Regulatory Support for Partners

We assist U.S. distributors, hospitals, and clinical partners with:

  • Establishment registration documentation
  • Device listing support
  • Technical file and quality documentation
  • Certificates of compliance
  • Importer and customs documentation

This ensures seamless entry of Smart Technology products into the U.S. healthcare system.

Certificates