Quality System Overview

MDD Hong Kong · MDACS · ISO 13485 · TR-001

Overview

Hong Kong's MDACS framework requires evidence of quality management system compliance as part of the device listing dossier. Both the legal manufacturer and the physical manufacturer (if different) must hold valid ISO 13485 certification.

ISO 13485 — Mandatory for Class II–IV

For Class II, III, and IV devices (and equivalent IVD classes), ISO 13485:2016 certification is mandatory. Requirements:

Requirement	Detail
Issuing body	Internationally accredited certification body (IAF/ILAC member)
Scope	Must cover the specific device category / product scope being listed
Status	Current at time of application and throughout listing validity
Coverage	Must cover both the legal manufacturer and physical manufacturer sites

Both certificates (legal and physical manufacturer) are submitted as part of the MDACS listing application. If both manufacturer roles are held by the same entity, one certificate covering the relevant site is sufficient.

Class I Devices — ISO 13485 Not Mandatory

Class I devices (and Class A IVDs) do not require ISO 13485 certification for MDACS listing. However, a basic quality system is expected, and the manufacturer's conformity declaration must still reflect a systematic approach to design, manufacture, and quality control.

Key QMS Elements

Under ISO 13485, the manufacturer's QMS must cover:

Element	Description
Management responsibility	Quality policy, objectives, management review
Resource management	Competence, training, infrastructure
Product realisation	Design controls, purchasing, production controls
Risk management	ISO 14971 integrated into the QMS
Monitoring and measurement	Complaint handling, internal audit, CAPA
Post-market feedback	PMS data feeding into the quality system

Local Responsible Person (LRP) QMS Obligations

The Local Responsible Person (LRP) — the Hong Kong-based entity that holds the MDACS listing — is not required to hold ISO 13485, but must maintain systems for:

• Receiving and logging complaints from Hong Kong users
• Evaluating complaints against adverse event reporting thresholds
• Managing FSCAs and recalls in the Hong Kong market
• Maintaining distribution records for traceability
• Cooperating with MDD inspections

See LRP Role for the full LRP obligation framework.

GDP for Distribution

Importers and distributors must maintain good distribution practice:

• Appropriate storage conditions (temperature and humidity where required)
• Segregation of approved, quarantined, and rejected stock
• FIFO stock rotation to prevent expiry
• Distribution records enabling full traceability

Maintaining QMS Compliance During Listing Validity

• Submit updated ISO 13485 certificates at renewal (5-year listing period)
• Notify MDD if the manufacturer's ISO 13485 certification is suspended or withdrawn
• If the manufacturing site changes, assess whether a listing variation is required
• Significant QMS changes (facility transfer, scope change) should be reported to MDD

QMS and MDACS Stage C Procurement

Since March 2026, devices procured by the Hong Kong Department of Health must be MDACS-listed. As part of this, QMS compliance is effectively a procurement prerequisite. Ensure ISO 13485 certificates are always current and renewal is planned well in advance of expiry.