Hong Kong MDACS Medical Device Grouping: Family, Series, and System Listing Rules

Quick answer

What are Hong Kong MDACS medical device grouping requirements?

Under Hong Kong's Medical Device Administrative Control System (MDACS), administered by the Medical Device Division (MDD) of the Department of Health, listing applications for Class II, III, and IV general medical devices (GMD) and Class B, C, and D in vitro diagnostic medical devices (IVDMD) may cover a single device, a medical device family, a medical device series, or a medical device system. Grouping rules are set out in Section C003 of Guidance Note GN-02 (GMD) and the corresponding application guidance in GN-06 (IVDMD). A Local Responsible Person (LRP) submits the chosen grouping through the Medical Device Information System (MDIS) using form MD101 for GMD or the IVD listing forms described in GN-06. For every member in a family, series, or system, the applicant must provide identifier(s) (product or model number) and distinguishing characteristics. Family members share the same manufacturer, device description, classification, intended use, design, construction, and performance but differ by attributes such as catheter lengths. Series members belong to the same model series with only minor feature differences. System members are component devices from the same manufacturer used together for the stated intended purpose. Confirm device class first using TR-003 (GMD) or TR-006 (IVDMD) before selecting a grouping type.

Who this applies to

This guide is for regulatory affairs teams, Hong Kong Local Responsible Persons (LRPs), and overseas manufacturers preparing MDACS listing dossiers.

Product scope: Class II, III, and IV GMD and Class B, C, and D IVDMD eligible for MDACS listing. Class I GMD and Class A IVDMD fall outside standard listing scope — grouping under GN-02/GN-06 does not apply to those exempt classes.

Out of scope: Dealer licensing, adverse event reporting, labelling detail (see TR-005), and expedited approval scheme eligibility — those are separate MDACS workflows. This article focuses on C003 grouping only.

MDACS grouping types overview

MDACS accepts four listing structures for eligible devices. Select exactly one structure per application unless MDD guidance directs otherwise.

All four options appear in GN-02 Section C003 for GMD listing. GN-06 applies the same family, series, and system concepts to IVDMD listing applications.

Before choosing a grouping type, classify each candidate member under TR-003 (GMD) or TR-006 (IVDMD). When multiple classification rules apply, use Rule 1 as the primary rule and assign the highest applicable class if rules conflict — the grouped application must reflect a consistent class across all members.

Medical device family — criteria and member identifiers

A medical device family covers devices that share core design identity but differ by specific attributes.

Family eligibility criteria (GN-02 C003)

All family members must share:

• The same manufacturer
• The same device description
• The same classification
• The same intended use
• The same design
• The same construction
• The same performance

Members may differ only by attributes — for example, catheter lengths, diameters, volumes, or other defined physical parameters that do not change the fundamental design, intended use, or risk class.

Per-member data required

For each family member included in the listing application, the applicant must provide:

1. Identifier(s) — product number, model number, or other official catalog identifier
2. Distinguishing characteristics — the specific attribute(s) that differentiate that member from others in the family (e.g., "120 cm length" vs "150 cm length")

Incomplete member tables are a common cause of MDIS completeness queries. Build the family table before drafting the technical dossier so labelling, IFU, and marketing approval documents reference the same identifiers.

When family grouping fits

Family grouping suits products where engineering and clinical performance are identical and only dimensional or capacity variants exist — guidewire lengths, syringe volumes, or cuff sizes on an otherwise identical platform. If intended use, design, or classification diverges between variants, family grouping is not appropriate; consider separate applications or a series/system analysis.

Medical device series — criteria and limits on design variation

A medical device series covers products in the same model series with limited variation.

Series eligibility criteria (GN-02 C003)

All series members must share:

• The same model series
• The same classification
• The same intended use

Variations between members are limited to minor features only. Designs, labelling, manufacturing processes, and processes must not be significantly different between series members.

Per-member data required

As with families, each series member requires:

• Identifier(s) (product/model number)
• Distinguishing characteristics describing the minor feature difference

Document why each variation qualifies as "minor" rather than a substantive design change. If manufacturing sites, materials, or labelling differ materially, MDD may treat members as separate devices.

Family vs series — practical distinction

When in doubt, map each variant against both definitions and choose the grouping that truthfully reflects the smallest permissible variation category.

Medical device system — component devices and combined intended use

A medical device system is a set of component devices from the same manufacturer that are used together to achieve the stated intended purpose.

System eligibility criteria (GN-02 C003)

System listing requires:

• Component devices marketed under the same manufacturer name
• A clear description of how the components work together to fulfil the intended purpose
• Consistent classification and intended-use alignment across components where applicable

Per-member data required

Each component device in the system needs:

• Identifier(s) for every component model or catalog number
• Distinguishing characteristics — role of the component within the system (e.g., console, probe, disposable sensor)

The system description should explain assembly, connection, and functional dependency between components. IFU and labelling must support combined use as described in the application.

System vs family/series

Systems address multi-component configurations, not attribute scaling on one device. A surgical kit with console plus disposable tips is a system candidate; three lengths of the same guidewire is a family candidate.

GMD vs IVDMD grouping (GN-02 vs GN-06)

Grouping logic is parallel across product types but uses different guidance notes and forms.

IVD portfolios with multiple reagent lots, instrument models, or panel configurations should still test each member against family, series, and system definitions before filing. Do not assume IVD grouping follows EU IVDR family rules — MDACS criteria in GN-06 control Hong Kong listing structure.

Cross-reference classification outcomes with TR-003 or TR-006 before completing C003 fields. Mixed-class bundles cannot share one grouped listing if classification differs.

Step-by-step: choose grouping type before MDIS submission

Follow this workflow when preparing a grouped MDACS listing application.

Step 1: Confirm listing eligibility and class

1. Classify each candidate device under TR-003 (GMD) or TR-006 (IVDMD).
2. Apply Rule 1 as the primary classification rule; if multiple rules apply, use the highest class.
3. Confirm all members are within MDACS listing scope (Class II–IV GMD or Class B–D IVDMD).
4. Verify the LRP is appointed and ready to submit through MDIS.

Step 2: Inventory all catalog numbers

Build a master list of every product or model number proposed for the application. For each row, capture intended use, design characteristics, and manufacturing details needed for the grouping assessment.

Step 3: Test each grouping definition

Evaluate the portfolio against definitions in order of restrictiveness:

1. Can all members qualify as a single device? (Only one catalog number)
2. If multiple members, do they meet family criteria (same design/construction/performance; attribute differences only)?
3. If not family, do they meet series criteria (same model series; minor features; no significant design/process differences)?
4. If multiple components used together, does the configuration meet system criteria (same manufacturer; combined intended purpose)?

Document the rationale for the selected grouping type in internal RA records.

Step 4: Prepare per-member identifiers and distinguishing characteristics

For every member in the chosen group, complete:

Align identifiers with marketing approval documents, labelling, and Essential Principles checklists submitted elsewhere in the dossier.

Step 5: Select the correct form and guidance note

• GMD: MD101 with GN-02 (Section C003 for grouping)
• IVDMD: Forms specified in GN-06 with the same grouping section

Download the current PDF editions from MDD's issued guidance index before filing — GN editions are updated periodically.

Step 6: Complete MDIS submission as LRP

1. Access MDIS through MDD's Medical Device Information System portal.
2. Start a new listing application for the correct product type.
3. Select the grouping type (single, family, series, or system) in C003.
4. Enter all member identifiers and distinguishing characteristics.
5. Upload the full technical dossier per GN-02 or GN-06 (Essential Principles evidence, QMS, labelling, clinical/performance evaluation, marketing approvals or CAB certificate as applicable).
6. Submit and retain MDIS acknowledgement references for post-market record keeping.

MDD's FAQ confirms that listing applications are submitted by the LRP via MDIS. Allow time for completeness review if member tables or classification rationale are unclear.

Step 7: Respond to MDD queries and maintain grouping integrity

If you add or remove catalog numbers after listing, assess whether the change stays within the approved grouping type. Material design or intended-use changes may require a new application or reclassification under TR-003/TR-006.

Comparison table: family vs series vs system

Key documents and what they must contain

Grouped listing dossiers still require the full MDACS documentation set. Grouping fields in C003 supplement — not replace — conformity evidence.

Checklist before filing MD101 or IVD listing in MDIS

• Every candidate member classified under TR-003 (GMD) or TR-006 (IVDMD)
• Rule 1 applied; highest class used when multiple rules apply
• All members within listing scope (Class II–IV GMD or Class B–D IVDMD)
• Grouping type selected: single, family, series, or system — with documented rationale
• Family test passed: same manufacturer, description, classification, intended use, design, construction, performance; attribute differences only
• Series test passed (if applicable): same model series; minor features only; no significant design, labelling, or process differences
• System test passed (if applicable): same-manufacturer components; combined-use description prepared
• Identifier(s) and distinguishing characteristics completed for every member
• Correct guidance note: GN-02 + MD101 (GMD) or GN-06 IVD forms (IVDMD)
• LRP designated and MDIS account ready
• Marketing approval or CAB documents reference all listed model numbers
• Current GN/TR PDF editions downloaded from MDD issued-documents index

Common pitfalls

1. Selecting family when intended use differs — family requires identical intended use across all members; different clinical indications need separate applications.
2. Treating redesigns as a series — series allows minor features only; significant design or manufacturing process changes fail series criteria.
3. Omitting distinguishing characteristics — GN-02 C003 requires both identifiers and distinguishing characteristics for each member; blank tables trigger MDIS queries.
4. Mixed classification in one group — all family and series members must share the same class; reclassify or split applications when Rule 1 outcomes differ.
5. System listing without combined-use narrative — systems require a description of how components work together; standalone accessories are not automatic system members.
6. Using EU or FDA grouping labels on MDIS — MDACS definitions in GN-02/GN-06 control Hong Kong filings even if foreign dossiers use different grouping language.
7. Wrong form for product type — MD101/GN-02 for GMD; GN-06 IVD forms for IVDMD; cross-form submission delays review.
8. Stale guidance editions — check MDD's issued-documents index for current GN-02 and GN-06 revisions before submission.

FAQ

What is a medical device family under MDACS?

A medical device family is a group of devices from the same manufacturer that share the same device description, classification, intended use, design, construction, and performance, but differ by attributes such as catheter lengths or sizes. Each member needs an identifier and distinguishing characteristics in GN-02 C003 or GN-06.

Can I list a device series in one MDACS application?

Yes. MDACS accepts medical device series listing when all members belong to the same model series, share classification and intended use, and differ only by minor features without significant differences in design, labelling, manufacturing, or processes. Provide identifiers and distinguishing characteristics for each series member.

What is the difference between family and series in Hong Kong?

Under GN-02 C003, a family shares identical design, construction, and performance with attribute-level differences (e.g., lengths). A series shares a model series with minor feature differences only and must not have significant design, labelling, or process differences. Choose the grouping that matches the smallest variation category supported by your technical documentation.

How do I group IVD devices for MDACS listing?

IVDMD listing uses the same family, series, and system concepts in GN-06 as GMD uses in GN-02. Classify reagents and instruments under TR-006, confirm Class B, C, or D eligibility, complete per-member identifiers in the IVD application form, and submit through MDIS as the LRP.

What identifiers are required per group member?

For each member in a family, series, or system, the applicant must provide identifier(s) — typically product or model numbers — and distinguishing characteristics that explain how that member differs from others in the group or its role in a system. This requirement appears in GN-02 Section C003.

Who submits grouped listing applications to MDD?

The Local Responsible Person (LRP) submits MDACS listing applications, including grouped family, series, and system filings, through the Medical Device Information System (MDIS). Overseas manufacturers should coordinate member tables and technical dossiers with their appointed LRP before MDIS submission.

Does grouping replace classification under TR-003 or TR-006?

No. Grouping determines how many devices share one listing application under C003. Classification still follows TR-003 (GMD) or TR-006 (IVDMD), using Rule 1 as the primary rule and the highest class when multiple rules apply. All grouped members must share a consistent classification for family and series applications.

Official sources

• Department of Health, MDD — GN-02 Guidance Notes for Listing Class II/III/IV General Medical Devices (Section C003 grouping): https://www.mdd.gov.hk/filemanager/common/mdacs/GN-02-E.pdf
• Department of Health, MDD — GN-06 Guidance Notes for Listing Class B/C/D In Vitro Diagnostic Medical Devices (grouping): https://www.mdd.gov.hk/filemanager/common/mdacs/GN-06-E.pdf
• Department of Health, MDD — Medical Device Information System (MDIS): https://www.mdd.gov.hk/en/mdacs/mdis/index.html
• Department of Health, MDD — Frequently asked questions (classification and listing scope): https://www.mdd.gov.hk/en/useful-information/frequently-asked-questions/index.html
• Department of Health, MDD — Issued guidance index (GN/TR/COP documents): https://www.mdd.gov.hk/en/information-publication/index.html#issued-documents
• Department of Health, MDD — TR-003 Classification of General Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR003E.pdf
• Department of Health, MDD — TR-006 Classification of In Vitro Diagnostic Medical Devices: https://www.mdd.gov.hk/filemanager/common/mdacs/TR006E.pdf