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Tagname : medical device compliance

  • Singapore Requires HSA Registration for Cryogenic Bio-Storage Imports
    Singapore HSA registration becomes mandatory for cryogenic bio-storage imports from July 1, 2026. Learn the Class A requirements, ISO 13485 documents, and customs clearance risks.
  • RCEP Biocompatibility Reports Gain Five-Market Acceptance
    RCEP biocompatibility reports now gain five-market acceptance, helping medical device firms cut duplicate testing, speed registration, and strengthen compliance planning.
  • NMPA Cracks Down on 4 Illegal Online Sales of Remote ECG & Home Vital Monitors
    NMPA cracks down on illegal online sales of remote ECG & home vital monitors—key alert for cross-border sellers, e-commerce platforms, and distributors. Act now to ensure NMPA filing compliance.
  • FDA Warns Centrifugation Tech Firms on Rotor Traceability
    FDA warns centrifugation tech firms on rotor traceability—urgent implications for global medtech supply chains, especially China-based ODMs. Act now to avoid 510(k) delays.

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