Labelling and IFU Requirements: Foreign Labels, Language and Compliance Points

1. Key takeaways

Labelling is a statutory duty, not a printing instruction. Section 4(c) of Act 737 requires the device to be labelled, packaged and marked in the prescribed manner. That makes label compliance an obligation on the manufacturer, comparable in standing to the design and manufacturing duties, rather than a formatting matter left to the distributor. The specific list of required elements is set by current MDA guidance, which is the document to work from rather than a legacy template.

Compliance has two dimensions that are usually managed separately and should not be. The first is content: whether the label and the instructions for use carry the required information. The second is consistency: whether that information matches the registration. A label can be complete and still non-compliant if it claims more than the registration allows, and this is the failure that carries consequences beyond a deficiency request.

• Legal basis: section 4(c) of Act 737 — labelling, packaging and marking in the prescribed manner.
• Language: the official languages include Malay and English; in practice English labels and IFU are the accepted mainstream form.
• Lay users: home-use devices intended for the public need readability for non-professional users, including warnings, symbols and complete operating steps.
• Consistency: registration information — name, intended use, classification — must match label claims strictly.
• IFU focus: principle 10, information supplied by the manufacturer.
• Escalation: from deficiency request to non-compliance with section 4(c), and potentially to an advertising issue under section 44.

2. Legal basis

Section 4(c) of Act 737 creates the duty. Principle 10 of Appendix 1 to the Third Schedule of MDR 2012, on information supplied by the manufacturer, defines the content expectation and is the principle against which the instructions for use are reviewed. MDA/GD-0032, the advertising guidelines, is relevant to the boundary between a label claim and an advertising claim. Language and home-use requirements follow current MDA guidance.

The IFU requirements are conventional in content and demanding in completeness: intended use, contraindications and warnings, method of use, storage and transport conditions, expiry, troubleshooting and contact details. Devices for self-testing or self-use carry additional requirements, which is consistent with the special protection given to those devices under the Essential Principles. Missing one element is usually treated as a deficiency; missing the same element repeatedly across a product family suggests the labelling process itself is not controlled.

3. Expert insights

Insight 1: the label is read against the registration, line by line. Both the CAB and the MDA compare the label with the registered name, intended use and classification. The comparison is not generous. A label that describes a broader use than the registration, or a narrower one, creates a discrepancy that has to be resolved before approval. This is why label text should be drafted after the intended use statement is settled, not in parallel with it.

Insight 2: language acceptance is a practice, not a licence to be careless. English labels and IFU are the mainstream accepted form in practice, which removes a translation burden for many applicants. It does not remove the readability requirement for home-use devices, where the test is whether a non-professional user can understand the warnings, interpret the symbols and follow the operating steps in full. A technically accurate translation that assumes clinical literacy fails that test.

Insight 3: the consequences are graded, and the top of the range is expensive. A defective label usually produces a deficiency request. Where the defect is substantive, it can be treated as non-compliance with section 4(c). Where the label claims more than the registration covers, the matter can extend to an advertising issue under section 44 (see article 45), which moves it out of the registration process entirely. The pattern is that the cheapest problems are drafting problems and the most expensive are claim problems.

Insight 4: three cross-checks cover most of the risk. The label claim against the registered intended use; the label warnings against the residual risks in the risk management file; the label language and reading level against the intended user. These three comparisons detect the discrepancies that reviewers find, and they can be run internally in an afternoon. A label that passes all three is rarely the subject of a labelling finding, because the findings cluster exactly at those interfaces.

4. Practical recommendations

• Run the three-way cross-check before submission. Label claims against intended use, label warnings against residual risks, label language against user level.
• Draft label text after the intended use is fixed. Sequencing prevents the most common discrepancy.
• Work from current MDA guidance. Do not rely on an older element list carried over from a previous submission.
• Test home-use labelling with lay readers. Ask whether the warnings and steps can be followed without clinical training.
• Keep one label version per registration. Record the label version alongside the technical file version so that neither drifts.
• Review claims for advertising exposure. Where label text approaches promotional language, check it against MDA/GD-0032 before printing.

The practical conclusion is that labelling should be treated as the last expression of the registration rather than as a separate production task. Everything the file asserts has to appear on the label in the same terms, and nothing may appear on the label that the file does not assert.

5. Verification checklist

• □ Label, packaging and marking comply with the prescribed manner under section 4(c) of Act 737
• □ Required elements confirmed against current MDA guidance
• □ IFU covers intended use, contraindications and warnings, method of use, storage and transport, expiry, troubleshooting and contact details
• □ Self-test and self-use devices meet the additional requirements
• □ Label claims consistent with the registered name, intended use and classification
• □ Label warnings traceable to residual risks in the risk management file
• □ Language and readability appropriate to the intended user, including lay users for home-use devices

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including Malaysia. Our team prepares dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the MDA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com