Hong Kong Class I and Class A Medical Devices: MDACS Listing Exemption Guide

Quick answer

Do Class A medical devices need MDACS listing in Hong Kong?

Class I general medical devices (GMD) and Class A in vitro diagnostic medical devices (IVDMD) are not under the current listing scope of Hong Kong's Medical Device Administrative Control System (MDACS), administered by the Medical Device Division (MDD) of the Department of Health. MDD's FAQ states explicitly that Class I GMD are outside the scope of medical device listing, and Class A IVDMD are outside the scope of IVD listing. Guidance Note GN-01 (Overview of the Medical Device Administrative Control System) confirms that MDACS listing covers Class II, III, and IV GMD and Class B, C, and D IVDMD only. Listing applications for in-scope devices are submitted by a Local Responsible Person (LRP) through the Medical Device Information System (MDIS). Exemption from listing does not mean a device is unregulated: manufacturers should still classify products under TR-003 (GMD) or TR-006 (IVDMD), confirm the product meets the medical device definition, and monitor other MDACS elements such as trader listing, adverse event reporting, and future statutory controls. Use MDD's web-based classification programs and the scope table below before assuming listing is required.

Who this applies to

This guide is for regulatory affairs teams, Hong Kong Local Responsible Persons (LRPs), overseas manufacturers, importers, and distributors evaluating whether a product needs MDACS medical device listing.

Product scope: General medical devices classified as Class I under TR-003, and in vitro diagnostic medical devices classified as Class A under TR-006. Accessories to listed devices follow the classification of the parent device. Animal-only products are outside MDACS medical device scope per MDD FAQ.

MDACS listing scope overview

MDACS is Hong Kong's voluntary pre-market administrative control framework, launched in November 2004 to align industry with the future mandatory legislative regime. The system's listing scope mirrors the proposed statutory framework described in GN-01 and the Overview of Hong Kong Medical Device Listing Process PDF published by MDD.

MDACS covers:

• General medical devices (GMD): Class II, III, and IV (medium to high risk)
• In vitro diagnostic medical devices (IVDMD): Class B, C, and D (medium to high risk)
• Traders: local manufacturers, importers, distributors (under separate guidance notes)
• Conformity Assessment Bodies (CABs): recognised under the CAB Recognition Scheme

Classification follows IMDRF-aligned rules in Technical Reference TR-003 (GMD) and TR-006 (IVDMD). Hong Kong uses a four-class system for each product type: Class I/A = lowest risk; Class IV/D = highest risk.

MDACS listing scope table

Listed devices appear in MDD's public List of Medical Devices searchable database. Class I GMD and Class A IVDMD will not appear there because listing is not currently accepted for those classes.

Class I general medical devices — exempt from MDACS listing

Class I GMD are the lowest-risk general medical devices under TR-003. Examples often include non-invasive, transient-contact products — but the actual class depends on design, duration of body contact, invasiveness, and other classification rules in TR-003, not product category alone.

MDD's FAQ states:

Please note that Class I general Medical Devices are not under the current scope of listing of Medical Devices under the Medical Device Administrative Control System.

GN-01 §3.3 describes the MDACS classification framework and listing scope. GN-01 §4.2.1 confirms that the LRP submits listing applications for devices within scope — which excludes Class I GMD. For Class II–IV devices, applicants follow GN-02 (Guidance Notes for Listing Class II/III/IV General Medical Devices) and submit form MD101 through MDIS.

Practical implications for Class I GMD:

• No MDIS listing application or MD101 submission for the device itself
• No entry on the public List of Medical Devices for that SKU
• Classification documentation should still be maintained — TR-003 rationale supports future compliance and customer due diligence
• If the device is reclassified upward (e.g., design change triggers Class II), listing becomes required before relying on MDACS market access

Class A IVDMD — exempt from MDACS listing

Class A IVDMD are the lowest-risk in vitro diagnostic devices under TR-006. Classification depends on factors including intended user expertise, diagnostic significance of the result, and public health impact — not simply whether the test is "simple."

MDD's FAQ states:

Please note that Class A IVD Medical Devices are not under the current scope of listing of IVD Medical Devices under the Medical Device Administrative Control System.

Class B, C, and D IVDMD require listing under GN-06 using form MD102 via MDIS. The Overview of Hong Kong Medical Device Listing Process PDF illustrates the same in-scope / outside-scope split for IVDMD as for GMD.

Common Class A IVDMD planning errors:

• Assuming all IVDs need MDACS listing — only Class B–D are in scope
• Using GN-06 or MD102 for a Class A product — wrong form and guidance note
• Confusing Class A IVDMD (Hong Kong IVD class) with Class I GMD (general device class) — different product types, same listing exemption outcome

What still applies despite the listing exemption

Exemption from MDACS device listing is not a blanket exemption from all regulatory obligations in Hong Kong.

If your portfolio includes both Class I and Class II devices, the LRP typically manages listing for the Class II+ SKUs while Class I products remain outside listing scope but still require correct classification records.

Class II–IV GMD and Class B–D IVDMD — listing required

When classification confirms a device is not Class I or Class A, MDACS listing is the standard voluntary market-access route.

Pathway options for in-scope devices include Pathway 1 (CAB Conformity Assessment Certificate) and Pathway 2 (reference marketing approvals from recognised jurisdictions). These pathways do not apply to Class I/A devices because listing itself is out of scope.

Listed vs exempt devices — comparison

Key documents and records to maintain

Even when Class I GMD or Class A IVDMD listing is not required, regulatory teams should retain:

MDD FAQ states that the manufacturer is best placed to apply TR-003 or TR-006 and provide classification information. Archive both the online classification program output and a written TR analysis — do not rely on the tool alone.

Decision tree: does my device need MDACS listing?

Use this sequence before initiating MDIS work or LRP engagement fees.

ASCII summary:

1. Confirm medical device status → if no, stop MDACS listing path
2. Determine GMD vs IVDMD
3. Classify → Class I or A = no listing; Class II–IV or B–D = listing required
4. For in-scope classes, proceed with LRP + GN-02/GN-06 + MDIS

Classification tools and technical references

Correct classification is the gate for the listing exemption decision. MDD publishes both written rules and interactive tools.

Step-by-step classification workflow

1. Confirm medical device status — MDD online tool: Is Your Product A Medical Device?
2. Select product type — GMD follows TR-003; IVDMD follows TR-006
3. Read classification rules — download TR-003 or TR-006 PDFs from MDD issued documents
4. Run web-based classification program — answer intended use, design, and risk-factor questions
5. Document rationale — retain classification record even when listing is not required
6. Revisit on change — design, intended purpose, or claims changes can reclassify the device

Official classification resources

MDD notes that classified examples are illustrative only — final class depends on actual design, intended use, and TR rule application.

Checklist

Use before concluding that MDACS listing is or is not required:

• Confirmed product meets MDACS medical device definition
• Determined GMD vs IVDMD product type
• Applied TR-003 (GMD) or TR-006 (IVDMD) classification rules
• Cross-checked class using MDD web-based classification program
• Recorded classification rationale in technical file
• If Class I GMD or Class A IVDMD — confirmed no MD101/MD102 listing path
• If Class II–IV or B–D — confirmed GN-02/GN-06 applies and LRP appointed
• Reviewed separate trader listing obligations (importer/distributor/manufacturer)
• Checked MDD website for latest GN-01, FAQ, and Overview PDF revisions

Common pitfalls

1. Treating "Class A" as a general device class — Class A applies to IVDMD only; general devices use Class I–IV.
2. Filing MD101 for Class I GMD — MDD does not accept listing applications for Class I under current scope.
3. Filing MD102 for Class A IVDMD — same exemption applies; GN-06 covers Class B–D only.
4. Skipping classification because listing is exempt — TR-003/TR-006 documentation remains essential for due diligence and future statutory compliance.
5. Assuming exemption means no Hong Kong regulatory planning — importer/distributor listing, vigilance, and labelling expectations may still apply.
6. Relying on foreign class alone — Hong Kong classification uses IMDRF-aligned TR rules; FDA Class I or EU Class I may not automatically map without TR analysis.
7. Ignoring portfolio mixed classes — Class I SKUs exempt; Class II+ SKUs in the same brand still need listing.
8. Using outdated GN links — verify current GN-01-E.pdf and FAQ on mdd.gov.hk before advising stakeholders.

FAQ

Do Class A medical devices need MDACS listing in Hong Kong?

No. MDD's FAQ confirms that Class A IVDMD are not under the current scope of IVD listing under MDACS. Class A is the lowest IVD risk class under TR-006. Listing applies to Class B, C, and D IVDMD via GN-06 and MDIS.

Is Class I GMD exempt from MDACS listing?

Yes. Class I general medical devices are not under the current listing scope of MDACS per MDD FAQ and GN-01. Class II, III, and IV GMD require listing under GN-02. Exemption from listing does not remove the need to classify under TR-003.

What is the lowest risk class in Hong Kong?

For general medical devices, Class I is the lowest risk class under TR-003. For in vitro diagnostic medical devices, Class A is the lowest risk class under TR-006. Both are outside current MDACS listing scope.

Can I sell Class I devices in Hong Kong without MDACS listing?

You do not need MDACS device listing for Class I GMD under the current voluntary framework. Confirm the product is a medical device, maintain TR-003 classification records, and review other obligations such as trader listing, labelling, and future statutory requirements before supply.

What is the difference between Class I GMD and Class A IVDMD?

Class I applies to general medical devices (non-IVD products) under TR-003. Class A applies to in vitro diagnostic medical devices under TR-006. Both are the lowest risk tier in their respective frameworks and both are outside MDACS listing scope today.

Does exemption from listing mean the device is unregulated?

No. MDACS listing exemption reflects scope limits of the voluntary listing programme, not a determination that the product is free of all controls. Classification, medical device definition, trader listing, vigilance, and the forthcoming statutory regime may still apply.

Which form do I use if my device needs listing?

MD101 with GN-02 for Class II–IV GMD. MD102 with GN-06 for Class B–D IVDMD. Submit through MDIS. Neither form applies to Class I GMD or Class A IVDMD under current scope.

Where can I verify MDACS listing scope officially?

Review MDD's FAQ (classification and listing sections), GN-01 §3.3 and §4.2.1, and the Overview of Hong Kong Medical Device Listing Process PDF on mdd.gov.hk. All confirm Class I/A outside listing scope.

Official sources

• Department of Health, Medical Device Division — Frequently Asked Questions (classification, Class I/A listing scope): https://www.mdd.gov.hk/en/useful-information/frequently-asked-questions/index.html
• Department of Health — GN-01 Overview of the Medical Device Administrative Control System: https://www.mdd.gov.hk/filemanager/common/mdacs/GN-01-E.pdf
• Department of Health — Overview of Hong Kong Medical Device Listing Process (scope diagram): https://www.mdd.gov.hk/filemanager/common/information-publication/Overview%20of%20Hong%20Kong%20Medical%20Device%20Listing%20Process.pdf
• Department of Health — TR-003 Classification of General Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR003E.pdf
• Department of Health — TR-006 Classification of In Vitro Diagnostic Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR006E.pdf
• Department of Health — MDACS hub: https://www.mdd.gov.hk/en/mdacs/index.html
• Department of Health — Web-based General Medical Device Classification Program: https://www.mdd.gov.hk/en/mdacs/online-tools/general-medical-device-classification-program/index.html
• Department of Health — Web-based IVDMD Classification Program: https://www.mdd.gov.hk/en/mdacs/online-tools/in-vitro-diagnostic-medical-device-classification-/index.html