Which class is your device, and which rule puts it there.

One law, two guidance documents, and they do different jobs.

• The law: First Schedule, Medical Device Regulations 2012 (P.U. (A) 500/2012). Appendix 1 holds Rules 1–16 for general medical devices. Appendix 2 holds a separate rule set for in-vitro diagnostics. Section 3 of Act 737 requires the establishment to classify its device under these rules.
• The explanation: MDA/GD/0009, Second Edition (April 2022). MDA’s guidance on the rules, with examples for each rule and decision trees. Its rule numbers match the First Schedule.
• The lookup list: MDA/GD/0062, Third Edition (13 June 2025). The classes of specific named device types, as agreed by ASEAN’s medical device committee under the ASEAN Medical Device Directive. MDA says it will update the list every year. It is not a rulebook: it does not explain rules. It records decisions, so check it for your device type before relying on your own reading. The other MDA guidance documents, with their current editions, are in our MDA guidance documents list.

Four risk tiers, with MDA’s own examples.

Examples from MDA’s general medical device page and MDA/GD/0009 Table 1. They illustrate the classes; they do not decide yours. Fees are per device and all-in: professional work, CAB and MDA statutory fees. Full schedule on pricing.

Classifying a device in eight steps.

This is the order MDA/GD/0009 sets out: confirm it is a medical device, fix the intended use, then work through every rule. Keep notes as you go. The registration application asks for the rule, not just the class.

1. Confirm it is a medical device. Under section 2 of Act 737, a device does not achieve its primary intended action by pharmacological, immunological or metabolic means. If that is in doubt, stop here: see what MDA will confirm below.
2. Check whether it is an IVD. Tests, reagents, calibrators and analysers for specimens taken from the body follow Appendix 2, not Rules 1–16. See the IVD registration guide.
3. Write down the intended purpose exactly as your label, IFU and brochure state it. The First Schedule requires the class to match that information. If the claims are vague, MDA’s guidance treats the device as intended for whatever use is accepted in general medical practice.
4. Decide how it enters the body. Not at all, or only on intact skin: Rules 1–4. Through a body orifice (including a stoma) without surgery: Rule 5. Through the body surface by surgery or other clinical procedure: Rules 6–8.
5. Fix the duration of continuous use. Transient is normally under 60 minutes; short-term 60 minutes to 30 days; long-term over 30 days. Removing a device and immediately replacing it with one of the same type counts as continuous use. A scalpel used on and off through a long operation is still transient, because each cut lasts seconds.
6. Check whether it is active. A device is active if it runs on electricity or another power source (not the body or gravity) and works by converting that energy. If so, apply Rules 9–12 as well as, not instead of, the rules above. ECG electrodes are normally not active. A syringe pushed by hand is not active; a spring-loaded injector wound in advance is.
7. Run the four additional rules. Rule 13: contains a medicinal substance with an ancillary action → D. Rule 14: made from or containing animal or human cells or tissue → D, unless it is non-viable animal material touching only intact skin (A). Rule 15: sterilising, or disinfecting as the final processing step → C, or B for disinfecting before that step, and C for contact-lens solutions. Rule 16: contraception or STI prevention → C, or D if implantable or long-term invasive.
8. Take the highest class and check the ASEAN list. If more than one rule applies, the higher class wins. Then look up your device type in MDA/GD/0062. Its list is marked normative: if your device type is on it, the class shown is the ASEAN-agreed answer.

Common devices, the rule that applies, and what changes the class.

ASEAN’s harmonised list (MDA/GD/0062) agrees where it covers the same devices. It lists the patient examination glove as A; the urological catheter as A, B or C by duration; the surgical knife as A if reusable and B if single-use; and antibiotic bone cement as D. These are illustrations. Your class follows your stated intended use.

The principles MDA applies.

• The higher class wins. If more than one rule applies, the higher class applies. The characteristic that gives the highest class decides the class of the whole device.
• Your paperwork is the intended use. To avoid a higher class, MDA’s guidance says the labelling must define the intended use so that the device falls in the lower class, with positive or negative indications. Loose marketing copy can raise the class.
• No specific body site? The most critical use counts. A device not limited to one part of the body is classified on its most critical specified use.
• Off-label use does not count. Accidental use, or use by a practitioner in a way the manufacturer did not intend, does not change the class.
• A competitor’s class is not a precedent. MDA’s own example: two sutures with the same composition can have different intended uses, and so different classes.

Where classification usually goes wrong.

Accessories are classified in their own right

An accessory is classified separately from the device it is used with, as if it were a device in its own right. When devices are used together, each one is classified separately. So the parts of one product can land in different classes. ASEAN’s list puts the blood pressure cuff in Class A, while an electronic blood pressure monitor is Class B under Rule 10(i).

Kits, sets and families

If you combine devices to create a new intended purpose, the combination is classified for that new purpose. If the purpose is unchanged, a set takes the class of its highest-classified device. Grouping follows the class too: every member of a family must have the same risk class. A range that spans Class B and Class C therefore cannot be registered as a single family. This affects cost directly, because grouping (single, family, system or set) decides how many registrations you pay for.

Software

Software that drives or influences a device, such as image-enhancement software in a scanner, takes that device’s class. Standalone software can be a medical device in its own right. MDA’s guidance treats it as active and applies the same rules. The ASEAN list gives anchors:

• Software that analyses earlier radiology images to help a clinician find abnormalities: B.
• A medical image analyser for diagnosis in critical conditions: C.
• Software for diagnosis or treatment: B, or C where it controls, monitors or directly influences a Class C active therapeutic device, or is intended for diagnosis when the patient is in immediate danger.

Drug–device combinations

Two questions, in order. First: is it a device at all? MDA’s interphase table decides by primary mode of action. A drug-eluting stent, or a dermal filler containing lidocaine, is a device–drug combination regulated by MDA as a medical device. Where the pharmacological, immunological or metabolic action is primary, the product is a drug and NPRA regulates it. Second: if it is a device, Rule 13 puts any device containing a medicinal substance with an ancillary action in Class D. Examples include heparin-coated catheters, antimicrobial wound dressings and blood bags with anticoagulant. MDA also charges a separate registration fee for devices that contain a medicinal product, and the drug component needs an NPRA endorsement first; see drug–device combination products.

Animal or human tissue

Rule 14 puts anything made from or containing animal or human cells, tissues or derivatives in Class D, viable or not. Examples are porcine heart valves and catgut sutures. The one exception: non-viable animal material that touches intact skin only, such as leather parts of an orthopaedic appliance, is Class A.

When the ASEAN list is more specific than the rule

Hearing aids are one of the Regulations’ own examples under Rule 9(i), Class B. But ASEAN’s harmonised list puts bone-conduction and transcutaneous air-conduction hearing-aid systems in Class C. Reading the rules alone would under-classify those. This is the case for always checking MDA/GD/0062.

IVDs use a different rule set

In-vitro diagnostics are classified by the risk to the individual patient and to public health, under Appendix 2 and guidance MDA/GD/0001. The IVD rules have their own numbering. MDA’s example: an HIV self-test is Class D under Rule 1, not Class C under the self-testing rule. A blood-glucose self-test is Class C, and a pregnancy self-test is Class B. See the IVD registration guide.

What MDA will confirm, and what it will not.

The class is yours to determine. Act 737 section 3 places classification on the establishment, and the First Schedule makes the manufacturer responsible for it. MDA’s registration application in MeDC@St asks for the class and the classification rule that justifies it. “Wrong classification” is one of the listed grounds for refusing a registration.

For Class B–D, the CAB assesses the device before MDA does. If you and the Conformity Assessment Body disagree about the class, you may ask MDA in writing within 30 days of the dispute. MDA decides and notifies you in writing, and its guidance states that the decision is final.

MDA’s product classification application answers a different question. It decides whether a product is a medical device at all. MDA states that it is not intended to determine the risk class or rule, and neither appears on the letter. Since 1 August 2026 it runs on MDA’s online Product Classification Application System, not MeDC@St. The old Google Form route is closed, and letters are issued by email only. On MDA’s published terms:

• RM300 per application, paid through BayarNow. Letters issued from 1 October 2026 are valid for 5 years; letters issued earlier with a 2-year validity were automatically extended to 3 years, and letters older than 5 years have a one-year window to apply for renewal (only if nothing on the letter has changed).
• Up to 10 products per application, all with the same product name, intended use and manufacturer. Each model number counts as one product.
• Documents include product information on intended purpose and mode of action, the label, a leaflet or brochure, and the IFU. Since 1 October 2026 MDA’s classification template is no longer uploaded: its fields are in the online form.
• A letter within 30 working days of cleared payment and complete documents (the invoice is issued within 7 working days). If a request for more information goes unanswered for more than 90 working days, the application is withdrawn.

Use it for borderline products, where the real question is whether you need MDA registration at all (the test is the Act 737 definition, which also settles accessories and spare parts). On the drug or cosmetic boundary, MDA’s interphase table applies and NPRA can confirm drug status (see NPRA or MDA?). For Class A versus Class B, the evidence is your rule-by-rule rationale, written into the dossier.

Everything after classification follows from the class.

• Route. Class A is exempt from CAB conformity assessment under paragraph 5 of the Medical Device (Exemption) Order 2024 (P.U. (A) 78) and is filed directly with MDA (see Class A registration). A Class A device that is sterile, or has a measuring function, must also include a validation report for that function. Class B, C and D need CAB conformity assessment before the MDA application.
• Grouping. The class limits which devices can share one registration (see families and sets above).
• Statutory fees. MDA’s own charges step up by class, as the table below shows.

Classification by device category

• IVD devices: test kits, reagents and analysers, under the separate IVD rules.
• Dental devices: Rule 5 for devices in the oral cavity, Rule 8 for crowns and fillings (B) versus implants (C).
• Aesthetic devices: energy-based devices under Rule 9(i), breast implants fixed at Class D, and fillers where the drug–device line matters.
• Surgical instruments: Rule 6, where reusable, single-use and powered versions of the same instrument fall into different classes.

Once the class is settled, the step-by-step registration guide covers everything after it, and the cost guide breaks down the budget.