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Hong Kong Medical Device Registration

Medical Device Control Office (MDCO) approval timelines and requirements

0.5-1 months

Typical Timeline

Device Classes

Yes

MDSAP Accepted

Required

Hong Kong Local Representative

Hong Kong Medical Device Registration Overview

Hong Kong medical device registration through MDCO typically takes 0.5-1 months for Class I devices. The official MDCO target is 1-2 weeks, but realistic timelines include preparation, documentation review, and potential questions from regulators.Hong Kong uses a 4-class (I, II, III, IV) risk-based classification system. Foreign manufacturers must appoint a Hong Kong Local Representative to register devices in Hong Kong. MDCO accepts MDSAP certification, which reference country certificates accepted. Registration is valid for No expiry (continuous listing).

Registration Timeline by Device Class

Hong Kong uses a 4-class (I, II, III, IV) risk-based classification system.

Class I

Listing

Low Risk

Official

1-2 weeks

Realistic

0.5-1 months

• Registration voluntary but recommended

Class II

Listing

Medium Risk

Official

1-2 months

Realistic

1-3 months

With Prior Approval

0.5-1 months

Accelerated with: FDA, EU CE Mark, Health Canada, Australia TGA, Japan PMDA

• Reference country approval expedites process

GMP/QMS Required

Class III

Listing

High Risk

Official

2-4 months

Realistic

2-5 months

With Prior Approval

1-3 months

Accelerated with: FDA, EU CE Mark, Health Canada, Australia TGA, Japan PMDA

• Reference country approval essential

GMP/QMS Required

Class IV

Listing

Highest Risk

Official

3-6 months

Realistic

3-6 months

With Prior Approval

2-4 months

Accelerated with: FDA PMA, EU CE Mark Class III

• Clinical data from reference country accepted

GMP/QMS Required

Expedited Pathways

Reference Country Reliance

Expedited listing for devices approved by reference countries

50-70% faster

Eligibility: FDA, EU, Health Canada, Australia TGA, or Japan PMDA approval

GBA Connect (Greater Bay Area)

Streamlined access to mainland China via Hong Kong

Access to 9 mainland cities

Eligibility: Hong Kong listed devices

Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your Hong Kong registration.

FDA 510(k)

Reference country - expedited listing

50-70%

EU CE Mark

Reference country - expedited listing

50-70%

Health Canada

Reference country

50-70%

Australia TGA

Reference country

50-70%

Japan PMDA

Reference country

50-70%

Key Requirements

Hong Kong Local Representative
Chinese/English labeling
Reference country approval certificate
ISO 13485 certification

Registration Validity:

No expiry (continuous listing)

MDSAP Benefit:

Reference country certificates accepted

Registration Process Flowchart

Hong Kong Medical Device Registration Process

Step-by-step MDCO registration process. Total estimated timeline: 0.5-1 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by MDCO. Appoint a Hong Kong Local Representative.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to MDCO including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

MDCO reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

1-2 weeks

In-depth technical assessment of device safety and performance. MDCO may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, MDCO issues Hong Kong market authorization certificate.

Summary: The Hong Kong medical device registration process through Medical Device Control Office (MDCO) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

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Related Resources

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Compare With

🇺🇸 United StatesFDA 🇪🇺 European UnionEU MDR 🇨🇳 ChinaNMPA 🇯🇵 JapanPMDA 🇧🇷 BrazilANVISA 🇨🇦 CanadaHealth Canada

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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.