Labelling and IFU Requirements in Myanmar

1. Key takeaways

The Technical Guidance for Online Submission of Medical Devices in Myanmar contains a dedicated labelling chapter (Section 3, Labelling). Labelling and the instructions for use (IFU) are mandatory documents at every risk class, the language requirement is Burmese and English, and the IFU content must cover indications, contraindications and instructions for use. These requirements apply identically to every product category on the registration pathway.

GRZAN note: labelling and the IFU are the only two documents that are not simplified at all even at Class A. The reason is that, regardless of risk level, safe use of the product depends on correct information being available to the end user. Information defects harm the patient directly, which is why the authorities refuse to scale this requirement down for lower-risk devices. Companies should therefore prepare them to the highest standard rather than scaling expectations down by class. The labelling coordinates are worth remembering: Section 3 of the guidance, 2 languages, and 3 core IFU elements. Companies that internalise these three numbers rarely need to be reminded of the rest, because every labelling decision flows from the section, the languages and the elements.

2. Legal basis

3. Expert insights

Insight 1: labelling and the IFU are required at every class, making them the two bottom lines that can never be simplified. A company that simplifies the labelling for a Class A product will trigger a formality-review rejection directly, because the requirement is not scaled to risk in this area. The uniform treatment also simplifies portfolio management: one well-built labelling template serves every class the company registers.

Insight 2: the bilingual requirement is a common sticking point at formality review. Burmese and English run in parallel, The absence of either language can lead to a request for correction, because the reviewer must be able to hand the same information to both the professional user and the regulator’s own inspection team. Companies must ensure that the two language versions correspond fully in content, rather than being drafted independently of each other. The usual failure mode is an English master document updated after the Burmese translation was made, leaving the Burmese text silently out of date at submission.

Insight 3: the IFU content must cover the three core elements. Indications define the scope of use, contraindications define the situations in which the device must not be used, and the instructions for use define the operating steps, including preparation, operation and any user actions after use. Without any one of the three, the reviewer cannot judge whether the product can be used safely. The three elements also anchor the post-market relationship between the device and its user, which is why the authorities treat their absence as a substantive defect rather than a formatting one.

Insight 4: the label specimen must carry traceability fields. Warning information, date of manufacture, expiry date and manufacturer information form the base data for post-market surveillance and recalls. A label that omits any of these fields undermines the traceability chain that the post-market system depends on. When a field-level correction later becomes necessary, the version ledger records what changed, when, and on whose authority.

Insight 5: labelling and the IFU must stay consistent with advertising text. Myanmar regulates promotion and advertising separately, and contradictions among the label, the IFU and the promotional materials create compliance risk that surfaces long after the registration is granted. Marketing teams should therefore receive the approved label and IFU as binding references, not as suggestions, whenever they draft campaigns.

4. Practical recommendations

• Prepare labelling and the IFU to the highest standard, without simplifying by class. Even Class A products should carry the complete set of elements.
• Ensure the Burmese and English versions correspond line by line. Build a bilingual comparison table and cross-check it whenever either version changes, so that a revision in one language cannot silently drift from the other.
• Treat indications, contraindications and instructions for use as mandatory IFU items. Correct any missing element immediately, since these three fields are the first thing the reviewer checks in the IFU.
• Mark every traceability field on the label specimen. Cover warnings, date of manufacture, expiry date and manufacturer information.
• Establish a consistency review between labelling and advertising text. Complete the comparison before any material is published.

5. Verification checklist

• □ The current text of the labelling rules in Section 3 of the guidance has been reviewed
• □ It has been confirmed that labelling and the IFU are mandatory at all four classes
• □ The Burmese and English versions have been aligned line by line
• □ It has been confirmed that the IFU contains indications, contraindications and instructions for use
• □ All traceability fields have been marked on the label specimen
• □ A consistency review between labelling and advertising text has been completed
• □ A label version management ledger has been established

Regulatory information verified as of 29 October 2026.

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