Grouping medical devices for MDA registration.
Grouping decides how many registration applications a product range needs, and so how many sets of MDA fees you pay. Get it wrong and MDA asks you to split the group and re-file. These are the rules from the Regulations and MDA’s two grouping guidance documents.
Three criteria every group must meet.
The Second Schedule of the Medical Device Regulations 2012 (paragraph 3) lets one registration application cover a group of devices. Every group, whatever its category, needs:
- One proprietary name,
- one manufacturer, and
- one common intended purpose.
All three must be met. A corporate headquarters may count as the manufacturer of devices made by its subsidiaries or regional sites. Each category below then adds its own conditions.
The six grouping categories
| Category | Used for | Key conditions | MDA’s example |
|---|---|---|---|
| Single | General and IVD | One device with one specific intended purpose, sold as a distinct packaged entity; may come in several pack sizes | Condoms in packs of 3, 12 and 144 |
| Family | General and IVD | Same manufacturer, risk class, proprietary name, intended purpose, design and manufacturing process; members differ only in the permissible variants of Annex C | IV administration sets differing in tubing length |
| System | General and IVD | Compatible components from the same manufacturer, used together for a common purpose and sold under a system name | Hip replacement system (femoral and acetabular components); glucose meter, strips, lancets and controls |
| Set | General | Two or more devices packed together by one manufacturer, with a single set name and a common intended use | First aid kit |
| IVD test kit | IVD | Reagents or articles used together for one specific purpose under a kit name; analysers excluded | HIV ELISA kit with controls, calibrators and wash buffers |
| IVD cluster | IVD | Same manufacturer, Class A or B only, same methodology, cluster category and test principle; analysers may be included | Clinical chemistry enzymes (amylase, lipase …) |
Sources: MDA/GD/0005 §4.3 (Second Edition, January 2024) and MDA/GD/0054 §4–5 (Second Edition, January 2021).
Family: the permissible variants are a closed list
Annex C of MDA/GD/0005 is a closed list, set product by product, of the only ways family members may differ: for catheters, the number of lumens, the curvature and the lubricious coating; for condoms, texture and flavour; for contact lenses, dioptre, UV protection, tint and colour. Materials are not permissible variants unless Annex C names them (it does for dental brackets and dental handpieces). MDA’s own example: titanium and stainless steel screw insertion tools cannot share one family. A “family of systems” is also possible, where several systems are registered together (§4.3.3.5).
Set: classed by its highest-risk device
A set takes the class of the highest-class device it contains (Second Schedule, paragraph 4(4)(a)(iii)). A promotional or convenience pack with no set name is not a set; each device in it is registered as a single (§4.3.4.7). For a system, neither the Regulations nor MDA/GD/0005 states a class rule, so it is worked out device by device under the First Schedule. See the classification guide.
IVD clusters and analysers
- The cluster category comes from a closed list of 45 in Annex E of MDA/GD/0054. MDA sets no maximum number of tests in a cluster.
- An analyser on its own is Class A, but it can be registered with assays of different classes by splitting the applications by assay class, for example one Class D and one Class C application that each include the same analyser (§5.2.7, §5.2.11).
- IHC reagents and FISH probes have their own six closed categories, all members being Class B or all Class C (§6).
- A cluster cannot be used to add new models later through a change notification (§5.5.8).
More on IVD classification and dossiers: IVD registration in Malaysia.
Special groupings in MDA/GD/0005
- IVF media, in four closed categories (§4.3.5).
- Class B hearing aids, grouped by design, amplification technology and whether they are wireless (§4.3.6).
Why grouping matters for cost
Each registration application pays the Fifth Schedule fees for its class. Since 1 January 2026 (P.U. (A) 330/2025) these are:
| Class | Application fee | Registration fee | Total |
|---|---|---|---|
| A | RM500 | RM750 | RM1,250 |
| B | RM250 | RM1,000 | RM1,250 |
| C | RM500 | RM2,000 | RM2,500 |
| D | RM750 | RM3,000 | RM3,750 |
Fifty catheter sizes filed as one valid family make one application; filed as singles, they make fifty. Grouping too aggressively is the opposite risk: MDA rejects a group that fails a criterion, and the products must be split and re-filed. Our fee guide shows the full cost picture: registration cost in Malaysia.
Common grouping mistakes we fix
- Two brand names under one “family”: different proprietary names cannot be grouped.
- Mixing materials (unless Annex C allows it) or risk classes in one family.
- Calling a distributor’s bundle a “set” when the manufacturer gives it no set name.
- Putting a Class C assay into an IVD cluster: clusters are Class A or B only.
- Selling a size or model that is not on the registered member list. Only listed members may be placed on the market (MDA/GD/0005 §4.3.3.3).
- Citing a dental grouping guidance. MDA/GD/0005 mentions one “under development”, but that number has since been used for a different guidance; dental devices follow MDA/GD/0005. See dental device registration.
Apakah pengumpulan (grouping) peranti perubatan untuk pendaftaran MDA?
Pengumpulan membolehkan beberapa peranti yang berkaitan didaftarkan dalam satu permohonan. Semua peranti dalam satu kumpulan mesti mempunyai satu nama proprietari, satu pengilang dan satu tujuan penggunaan yang sama (Jadual Kedua, Peraturan-Peraturan Peranti Perubatan 2012). Kategori: tunggal, famili, sistem, set, kit ujian IVD dan kluster IVD (MDA/GD/0005 dan MDA/GD/0054). WhatsApp 010-206 2070.
Frequently asked questions
What is product grouping in MDA registration?
What are the grouping categories?
What must every device in a group have in common?
Can devices of different materials be one family?
What class is a set or kit?
How many tests can go into an IVD cluster?
Can we sell a family member that is not listed?
Have a product range to group?
Send the product list with model numbers, materials and IFUs. We will propose the grouping against MDA/GD/0005 or MDA/GD/0054, so you pay for as few applications as the rules allow and none of them comes back.