Active Devices and Software Document Requirements

1. Key takeaways

Myanmar imposes additional document requirements for active medical devices: applicants must submit a declaration of conformity with international electrical safety standards (such as IEC 60601-1) and software lifecycle process documents (such as IEC 62304). In addition, the local authorised representative must submit a notarised declaration of the legal manufacturer confirming that the software versions distributed in Myanmar are identical to the versions validated under the CE-marked technical file.

GRZAN note: this requirement elevates software version management from a technical matter to a compliance matter. The software version control process of the company must be able to produce verifiable evidence of version correspondence; otherwise a clarification request will follow at submission or during the deficiency-response stage, and every such round consumes project time that was never budgeted for.

2. Legal basis

The table below collects the requirements that apply to active devices and to software-bearing products in the Myanmar framework. Reviewers verify each element during the formal and technical checks of the dossier.

3. Expert insights

Insight 1: the additional requirements target the specific subset of active devices. Passive consumable products do not fall within the scope of the IEC 60601-1 and IEC 62304 additional documents. Companies must therefore determine whether the product is active before fixing the document list, and the answer shapes the whole preparation plan. A product family that contains both active and passive items needs two parallel document tracks rather than one, and mixing the tracks at submission invites deficiency letters. The classification question is not academic: it decides which standards evidence the reviewer expects to see on the first pass.

Insight 2: the version consistency declaration is a Myanmar-specific requirement. The requirement binds the software versions distributed in Myanmar to the versions validated under the CE technical file, and the binding statement must be notarised. Its regulatory intent is to close the common gap in which the certified version and the actually supplied version are not the same. Regulators elsewhere face the same problem, but Myanmar makes the commitment explicit and formal. For companies, this means the declaration cannot be a broad statement of intent: it must identify the versions precisely, so that the authority can compare the document against the technical file and against the product as placed on the market.

Insight 3: the declaration is submitted by the AR, but its content is issued by the legal manufacturer. The division of duties is clear: the manufacturer produces the content, and the AR handles the procedure. Neither side can complete the step alone, and a lack of synchronisation between the two causes submission delays. The practical consequence is that the two parties must agree on timing: the manufacturer prepares and notarises the declaration, the AR checks it against the rest of the dossier, and only then is the package submitted. Companies that leave this handover undefined discover the gap at the worst possible moment, namely when the submission slot is already booked.

Insight 4: the software lifecycle requirement points to process, not outcome. IEC 62304 is concerned with process control in software development and maintenance. What companies must prepare is process evidence, not only a test report. A testing summary, however thorough, demonstrates that the version worked at a point in time; it does not demonstrate that the organisation can control change, regression and maintenance over the life of the product. Documentation of the lifecycle process therefore carries independent weight in the review, and teams that treat the standard as a documentation exercise rather than a testing exercise are far better positioned to answer reviewer questions.

Insight 5: the requirement is consistent with the wider ASEAN regulatory trend on software devices. The Myanmar approach aligns with the direction of regional attention to software as a medical device. Companies that prepare their software evidence to a regional standard rather than to a single-country interpretation can reuse the same package across neighbouring markets, which raises efficiency across the whole submission programme. The investment in disciplined version management therefore pays twice: once for the Myanmar application and once for every subsequent market that asks the same question in slightly different words.

4. Practical recommendations

• Determine whether the product is active before fixing the additional document list. Prepare the IEC standard documents separately for active devices.
• Build a ledger mapping software versions to the CE technical file. Ensure that consistency evidence can be produced at any time on request.
• Have the legal manufacturer issue the version consistency declaration and arrange notarisation. The content must be precise down to the version number.
• Submit the additional documents through the local authorised representative. Clarify the division of submission duties between the two parties in writing.
• Reserve time for the notarisation of the version declaration. Do not schedule it as something that can be completed instantly.

5. Verification checklist

• □ It has been confirmed whether the product is an active medical device
• □ The IEC 60601-1 declaration of conformity has been prepared
• □ The IEC 62304 software lifecycle process documents have been prepared
• □ The notarised software version consistency declaration has been obtained
• □ The ledger mapping software versions to the CE technical file has been established
• □ The division of submission duties between the manufacturer and the AR has been clarified
• □ 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