Skip to content
Compliance dossier · 2026

Every shipment,
bank-verifiable
on first submission.

This page is the public summary of the GHM compliance framework. The full dossier — suitable for bank verification, regulatory submission, and supplier onboarding — is available on request.

0actions
compliance actions on file
100%
HS-code accuracy on submission
24h
RFQ response — business days
The framework

Seven pillars. Each one, auditable.

01 / 07

CE Marking

Every device in the GHM catalogue carries a valid CE mark under the European Medical Device Regulation (MDR 2017/745). Certificates are issued by EU-accredited Notified Bodies — typically TÜV SÜD (NB 0123), TÜV Rheinland (NB 0197), BSI (NB 2797), IMQ (NB 0051), or DEKRA (NB 0344) depending on the manufacturer of record. The exact NB number, certificate number, and validity dates appear on the Declaration of Conformity attached to every shipment.

  • Directive: (EU) 2017/745 MDR
  • NB number per device on the Declaration of Conformity
  • Certificates released per device family on request
02 / 07

ISO 13485 Quality System

GHM sources exclusively from manufacturers operating an ISO 13485:2016-certified quality management system. Our internal supplier audit, active since 2024, verifies scope and validity before a device enters the GHM catalogue.

  • ISO 13485:2016 across supply chain
  • Annual supplier re-qualification
  • Internal audit log retained 10 years
03 / 07

EU MDR Compliance

Packaging, labelling, UDI, and Declaration of Conformity for every shipment are validated against EU MDR before dispatch from Hong Kong. GHM retains the technical file for each device family for the full regulatory lifecycle.

  • UDI carrier on every unit
  • Multilingual IFU where required
  • DoC retained for 10 years post-distribution
04 / 07

Anti-Bribery & Anti-Corruption

GHM operates under an explicit anti-bribery policy aligned with the UK Bribery Act 2010 and the OECD Anti-Bribery Convention. All commercial agents sign the GHM code of conduct before onboarding. No facilitation payments, full stop.

  • UK Bribery Act 2010 alignment
  • Signed agent code of conduct
  • Zero facilitation payments policy
05 / 07

Sanctions Screening

Every customer and every destination is screened against OFAC, EU Consolidated, UN, and HKMA sanctions lists on entry and before each shipment. Screenings are logged and retained for audit for a minimum of five years.

  • OFAC · EU · UN · HKMA screening
  • Re-screen on every order
  • Audit log retained ≥ 5 years
06 / 07

Customs & Trade

Every commercial invoice declares the HS code, Incoterms 2020, country of origin, and value in the buyer's preferred currency. Cold-chain logistics partners hold WCO SAFE-compliant status. We do not ship without a clearance plan.

  • HS codes declared per line
  • Incoterms 2020 throughout
  • Cold-chain WCO SAFE compliant
07 / 07

HSBC Hong Kong

HSBC Hong Kong is GHM's principal banking partner. Every commercial invoice carries the HSBC trade reference at the top, enabling bank verification on first submission — critical for letters of credit, documentary collections, and open-account transactions with regulated buyers.

  • HSBC trade reference on every invoice
  • LC, CAD, and open account supported
  • BR number available under NDA
Request · NDA-protected

The full dossier, on request.

Banks, regulators, and procurement officers can request the complete 2026 Compliance Dossier (124 pages, PDF) directly from the compliance desk.