Dual-Layer Post-Market Surveillance: Proactive Sampling and Passive Monitoring

1. Key takeaways

Post-market surveillance in Myanmar operates on a dual-layer structure. The proactive layer consists of active market sampling conducted every 2 months (active monthly market sampling every 2 months); the passive layer relies on monitoring implemented through adverse event (AE) reports from manufacturers and importers and through field safety corrective actions (FSCA). The competent authority has stated clearly that it will strengthen post-market surveillance activities through collaboration with manufacturers, importers and distributors.

GRZAN note: this dual-layer design means that companies cannot simply wait for regulatory spot checks. The passive monitoring obligation rests squarely on manufacturers and importers, and failure to report proactively constitutes a breach of duty in its own right. Companies should therefore treat the vigilance system as a continuously operating function of the organisation, with documented procedures and named responsible persons, rather than as a temporary action assembled only when an inspection is anticipated. In practice, the difference between the two postures becomes visible exactly when the authority asks for data: a functioning system produces evidence immediately, while an improvised one produces delays.

2. Legal basis

The table below summarises the official source and the main elements of Myanmar’s post-market surveillance framework as notified by the authority.

3. Expert insights

Insight 1: the sampling frequency of the proactive layer creates a predictable compliance rhythm. Sampling every 2 months means that the examination of market samples has a routine, normalised character rather than being an occasional enforcement campaign. Any batch placed on the market may in principle be drawn and tested, so companies must ensure that products in circulation continuously conform to the applicable standards. A quality level that is acceptable on the day of registration but drifts afterwards will eventually be detected by this regular cycle, and the detection will then be retrospective rather than prospective.

Insight 2: the passive layer assigns reporting duties directly to manufacturers and importers. The notification refers expressly to “adverse event reports and field safety corrective actions from manufacturers and importers”, which makes clear that reporting is not an optional gesture. It is a structural component of the surveillance system. The absence of reports when reportable events occur is itself a compliance failure, and it is a failure that can be identified during inspections or when the authority cross-checks market sampling findings against the company’s reporting record.

Insight 3: the collaborative reinforcement mechanism places companies in the position of information providers. Because the authority strengthens surveillance through cooperation with enterprises, companies must be able to supply data and explanations on demand. A company that cannot retrieve batch records, distribution data or complaint files promptly will find the collaboration one-sided, and that imbalance works against it during any inquiry. Readiness to answer is part of the compliance posture, not a courtesy.

Insight 4: supervision of high-risk devices introduces the participation of clinical professionals. The involvement of clinical professionals indicates that the supervision standard for high-risk products is set higher than for ordinary products. Companies placing such devices on the market should prepare more substantial technical support material, including evidence that anticipated clinical use conditions are understood and controlled, so that questions raised during collaborative supervision can be answered without delay and without improvised documentation.

Insight 5: the proactive and passive layers together form a complete market surveillance network. Sampling detects products that fail on the shelf; AE reporting and FSCA detect problems that emerge in actual use. Because the two channels complement each other, the correct corporate posture shifts from “passing the spot check” to continuous conformity: the objective is that every batch, in every distribution channel, remains within the approved specification at all times, so that neither layer of the network can catch the company off guard.

4. Practical recommendations

• Establish the vigilance system as a continuously operating function. Assign dedicated personnel and written SOPs, so that the passive layer keeps running whether or not an inspection is scheduled.
• Maintain stable batch quality in line with the 2-month sampling rhythm. Do not relax controls in periods when no sampling is known to have occurred; the cycle repeats routinely and any batch in circulation may be drawn.
• Build a process for adverse event collection and reporting. Cover both the distribution chain and the clinical side, so that events reach the responsible person quickly and completely before any external deadline is missed.
• Prepare clinical technical support material for high-risk products. Keep it ready for collaborative supervision involving clinical professionals, and update it whenever the product or its intended use changes.
• Ensure that market sample test results are traceable to batch records. Establish the correspondence between a tested sample and the batch documentation, so that any finding can be investigated and answered systematically rather than reconstructed under pressure.

5. Verification checklist

• □ The proactive layer has been confirmed as market sampling every 2 months
• □ The passive layer has been confirmed as covering AE reports and FSCA
• □ A continuously operating vigilance system has been established
• □ An adverse event collection and reporting process has been established
• □ Technical support material for high-risk products has been prepared
• □ Traceability between sample testing and batch records has been established
• □ The items have been incorporated into the registration ledger

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