Clinic Licensing Service

Clinic licensing compliance Illustration of a clinic paperwork checklist, healthcare staff, and compliance dashboard.
HC-Compliance

Your Strategic Partner for Compliance Under the Private Healthcare Facilities Ordinance (Cap. 633)

We provide a comprehensive solution for medical operators seeking full licensure in Hong Kong. Our end-to-end package mitigates regulatory risks and ensures strict compliance with the Code of Practice for Clinics.

Phase 01

Feasibility Study & Site Assessment

  • Regulatory Viability Analysis: Evaluate your intended clinic business model against the Office for Regulation of Private Healthcare Facilities (ORPHF) standards to determine if you require a Clinic Licence.
  • Premises Suitability Review: Assess the structural, zoning, and building design limits of potential premises before you sign a commercial lease.
Phase 02

Operational Planning & Floor Plan Optimization

  • Floor Plan Layout Advisory: Partner with your designers to ensure designated medical procedure rooms, consultation rooms, and decontamination areas comply with clinical workflows and space partitions.
  • Staffing Structure Planning: Outline the mandatory human resource framework, establishing compliant chains of command between clinicians and management.
  • Core Document Architecture: Organize corporate registries, medical indemnity assurances, and business registrations to support a seamless corporate entity application.
Phase 03

Standard Operating Procedures (SOP) Development

We draft, structure, and assemble your comprehensive operational manuals as mandated by the Department of Health:

  • Clinical Governance: Guidelines on medical record management, patient confidentiality, and incident reporting mechanisms.
  • Infection Control (IC) Manual: Detailed procedures for clinical waste disposal, instrument sterilization tracking, hand hygiene, and personal protective equipment (PPE) deployment.
  • Risk Management & Contingency: Protocol maps for life-safety equipment failure, power outages, and medical emergency responses.
  • Cold Chain & Pharmaceutical Management: Design protocols for dangerous drugs storage and mandatory vaccine fridge temperature logging logs.
Phase 04

Device Documentation & Healthcare Engineering Compliance

  • Inventory Logging: Structuring medical equipment registries with strict technical specifications.
  • Maintenance & Calibration Schedules: Compiling documentation for critical and life-saving equipment.
  • Engineering Checklists: Preparation of mandatory Form submissions verifying healthcare engineering, ventilation, and critical backup systems.
Phase 05

Chief Medical Executive (CME) Onboarding Support

  • Fitness & Properness Preparation: Compiling vetting profiles, credentials, and documentation aligning with guidance notes.
  • Declaration Execution: Preparing and auditing Form (Declaration by the CME) for signature.
Phase 06

Clinical Team Training (IC & Nursing)

  • Infection Control Workshops: Hands-on onboarding for nursing and auxiliary staff regarding sterilization verification and sharp-object safety protocols.
  • SOP Drills: Simulated walkthroughs of patient emergency procedures, drug dispensing verification, and complaint logging.
  • Compliance Drill Records: Generating training logs required by inspectors during on-site reviews.
Phase 07

Application Submission & Inspection Management

  • e-Licensing Account Management: Uploading data and handling submissions accurately via the regulatory portal.
  • Pre-Inspection Audit: Conducting a mock review utilizing official Form.
  • On-Site Inspection Escort:Our senior consultants physically accompany your CME and clinic team during the physical inspection to address inspector queries on the spot.
  • RFI Resolution: Promptly managing and answering all subsequent Requests for Information (RFI) or remedial layout changes requirements.

Usual Working Timeline

  • Week 1 - 2 Feasibility, layout consultation & preliminary floor plans
  • Week 3 - 6 SOP manual drafting, staff structure & device registry compilation
  • Week 7 Staff & IC training drills + CME final signatures
  • Week 8 Electronic portal submission & demand note tracking

Inspection: On-Site Representation (Scheduling dictated by DH waitlist)

Welcome for enquiries