Additional Requirements for Active Devices and Software: 2026 Updates

1. Key takeaways

According to industry observation in 2026 (practical estimate), the Ministry of Health of Myanmar has introduced additional documentary requirements for active medical devices: a declaration of conformity with international electrical safety standards (such as IEC 60601-1) must be submitted, together with software lifecycle process documentation (such as IEC 62304). In addition, the local authorised representative must submit a notarised declaration of the legal manufacturer confirming that the software version distributed in Myanmar is identical to the version verified under the CE-marked technical documentation.

GRZAN note: this requirement elevates software version management from a technical matter to a compliance matter. A company’s software version control process must be able to produce verifiable evidence of version correspondence; version inconsistency triggers technical review and can, as a practical estimate, delay the import licence by several weeks. The requirement is unusual precisely because it addresses a gap that purely documentary checks tend to miss: the certificate on file may describe one version while the boxes shipped describe another, and only a deliberate declaration forces the two to be reconciled. Treating the reconciliation as a standing process, rather than a one-off document, is what makes the requirement manageable over successive releases.

2. Legal basis

The table below summarises the additional requirements, the documents involved, the submitting subject and the consequences under the practical estimate.

3. Expert insights

Insight 1: the additional requirements target the specific subset of active devices. Passive consumable-type products are not covered, so determining whether a product is active is the first fork in defining the document list. The determination should be made deliberately and recorded, because it drives the whole downstream preparation: a product line that mixes active and passive items needs two document checklists, and applying the active list to everything wastes effort while applying the passive list to an active device creates a deficiency at submission. Getting this single classification decision right prevents most of the avoidable churn in the document list.

Insight 2: the version consistency declaration is a distinctive Myanmar requirement. Binding the version distributed in Myanmar to the CE-verified version, and requiring notarisation, reflects a regulatory intent to close the gap between the certified version and the version actually supplied. For manufacturers, this makes release management upstream of the declaration: if distribution cannot be tied to a documented version identity, the declaration cannot honestly be made, and the process must be fixed before the document is requested.

Insight 3: the declaration is issued by the manufacturer and submitted by the AR, with separated duties but shared consequences. If either party is out of sync, the submission is delayed. The separation is deliberate, but the consequence lands on the submission timetable that both parties share, which means the interface between the manufacturer’s release process and the AR’s submission calendar must be agreed before the first submission, not negotiated during a deficiency response. In practice this reduces to two questions answered in advance: how the declaration is requested, and how long notarisation takes.

Insight 4: the trigger for technical review is version divergence. This points companies toward maintaining a software version ledger that ensures the declared content corresponds exactly to the versions actually distributed. The ledger should record, for each distributed version, the release date, the CE verification reference and the declaration that covers it, so that any question about correspondence can be answered by inspection rather than by investigation. A ledger maintained in this form also makes updates routine: each new release adds an entry, and each entry keeps the standing declaration current.

Insight 5: the requirement is consistent with the regional regulatory trend on software as a medical device. Preparing to a unified regional standard improves efficiency, because the same IEC 62304 documentation and version traceability serve submissions in several markets at once. Companies that build the capability for Myanmar therefore obtain reusable value across the region rather than a country-specific artefact, and the incremental cost of regionalising the ledger after Myanmar is small compared with building it twice.

4. Practical recommendations

• Determine whether the product is active first, then define the additional document list. Prepare the active-device documents separately, and record the determination so the basis of the list is auditable.
• Maintain a ledger mapping software versions to the CE technical documentation. Evidence must be producible on demand, not assembled after a question is raised.
• Have the legal manufacturer issue the version consistency declaration and arrange notarisation. State the version numbers precisely, so the declaration can be checked against distribution records without interpretation.
• Submit the additional documents through the local authorised representative. Define the division of duties, including who holds the notarised original and who files the copy.
• Reserve time for notarisation of the version declaration. Do not schedule as if it could be completed on the spot; notarisation runs on external timelines the company does not control.

5. Verification checklist

• □ Whether the product is an active medical device has been confirmed
• □ The IEC 60601-1 declaration of conformity has been prepared
• □ The IEC 62304 software lifecycle process documentation has been prepared
• □ The notarised software version consistency declaration has been obtained
• □ A ledger mapping software versions to the CE technical documentation has been established
• □ The division of submission duties between manufacturer and AR has been defined
• □ Time has been reserved for the notarisation step

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