Importation and Distribution Records: Traceability Requirements and Retention Periods

1. Key takeaways

Requirement. Under AO No. 2025-0030 (effective 6 May 2026), companies must maintain importation and distribution records that support traceability. The records must contain the name and address of the initial consignee, device identification and quantity, date shipped, and lot/batch number or serial number. The retention period is the longer of the following: the expected useful life of the device (following the guidance of ISO/TR 14969), or 2 years from the date of shipment; for devices intended solely for export, 2 years from the date of shipment.

• Six data elements are mandatory: consignee, device identification, model, lot or serial number, quantity and shipment date.
• Retention is product-specific, not a single number. The longer-of rule means the retention table must be built by product category.
• Complaint records carry a different, longer clock: the expected useful life plus 5 years.
• Implant data needs its own procedure, because the data originates with healthcare facilities rather than with the company.
• Batch-level records are the precondition for a bounded recall; without them the recall scope defaults to the entire product line.

2. Legal basis

The obligation sits in AO No. 2025-0030 and is being further specified in a draft FDA guideline that is still open for comment. The table below summarises the elements that matter when designing the record system. Two points deserve attention before the table is read: the record requirement attaches to the transaction, not to the invoice, so internal stock transfers between affiliates and consignment movements also need to be captured; and the retention rule is expressed as a formula, which means each company must compute its own answer for each product rather than adopt a published figure.

3. Expert insights

Insight 1: the design objective of traceability is the ability to withdraw completely and quickly.

The logic behind the required data elements is straightforward: if a recall becomes necessary, the company must be able to answer who received this shipment, which lot went out, how many units, and when. A record without a lot or serial number forces the withdrawal scope to expand to the entire product, and the cost rises by orders of magnitude. Lot-level records are therefore not a formality; they are the control mechanism for recall cost. The same data set also determines how quickly a field action can be closed, because every consignee that cannot be identified individually must be contacted as part of a general notification.

Insight 2: the longer-of retention rule hits implantable devices hardest.

For ordinary consumables, 2 years is usually the ceiling. For implantable devices, the expected useful life can run far beyond 2 years (orthopaedic implants and heart valves are the obvious examples), and the retention period extends accordingly. Companies should not set a single 2-year retention policy across the portfolio; they should set a retention table by product category, with the basis for each period recorded next to it. That table then becomes the reference for both the SOP and any inspection response.

Insight 3: complaint records are retained for the expected life plus 5 years, longer than distribution records.

This is an easy point to confuse. Distribution records follow the longer of the expected life or 2 years; complaint records follow the expected life plus 5 years. The complaint period is materially longer because those records carry the complete evidence of the product safety history. Mixing the two rules in a single retention schedule is a common internal error, and it usually surfaces only when a regulator asks for records from an older batch.

Insight 4: retaining implant data is a separate obligation.

AO No. 2025-0030 requires companies to have a procedure for retaining implant data provided by healthcare facilities. For implant manufacturers this is an additional duty that sits outside the ordinary distribution record: it requires an established channel with hospitals for receiving and storing the data, and a defined format for what is handed over. A company that has never received such data has no channel to receive it, and the gap is only discovered when the data is needed.

4. Practical recommendations

• Build a retention table by product category. Do not apply 2 years uniformly; extend the period for implantables according to expected useful life, and record the reasoning for each category.
• Standardise the record fields. Consignee, product name, model, lot or serial number, quantity and shipment date are mandatory on every transaction line, with no free-text substitutes.
• File complaint records separately and retain them for the life plus 5 years. Keep the schedule distinct from the distribution record schedule so the two rules are never merged in practice.
• Open a channel for implant data. Agree with healthcare facilities how data will be transferred, in what format and at what interval, and keep evidence of the agreement.
• Connect the record system to the recall process. Confirm that a complete distribution list can be produced within 24 hours when a recall is initiated, and test that capability rather than assuming it.

5. Verification checklist

• □ The six record elements are captured on every transaction (consignee / product and model / lot or serial number / quantity / date / device identification)
• □ Distribution record retention set as the longer of expected life or 2 years
• □ Export-only device retention set at 2 years after shipment
• □ Complaint record retention set at expected life plus 5 years
• □ Implant data procedure documented, with a hospital agreement in place
• □ Recall traceability tested: a complete distribution list can be produced within 24 hours

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