Documented custody for medical devices means every lot moves with a defensible chain-of-custody file. Under the T21 column, FDA and COFEPRIS pressure makes custody the entry ticket — few sell it as a priced product.
- US sanitary regulator
- FDA
- Mexico counterpart
- COFEPRIS
- distribution discipline
- GDP/BPD
Cluster: hub · trip file · border margin.
What documented custody is
A continuous record that answers: which lot, which seal, which vehicle, which handler, which conditions, which delivery proof — without gaps a QA auditor can attack.
FDA and COFEPRIS roles
| Regulator | Logistics implication |
|---|---|
| FDA (US) | Device makers audited on distribution controls into the US |
| COFEPRIS (MX) | Mexican sanitary controls on manufacture / distribution |
Manufacturers must audit who moves product — your file becomes part of theirs.
Good distribution practice
See the glossary on good distribution practice (GDP/BPD). It is the playbook layer under custody: training, segregation, deviations, temperature when applicable.
Who must care
- Device manufacturers and importers
- Specialized carriers / 3PLs selling healthcare lanes
- Shippers whose customers treat logistics as a controlled process
Evidence per lot and trip
Elige un paso para ver el detalle
Detalle del paso · 01
Lot / serial references
From pickup to audit
Flow
Operable order
Pickup
Lot + seal
In transit
No gap
Deliver
POD
Audit
One file
Regulatory file
OCL agents assemble lot-level evidence (who, when, seal/temperature, integrity) on the trip ID with computer use. QA and regulatory counsel own the FDA/COFEPRIS conclusion. OCL is not a health authority.
Key takeaways5 points
- FDA (US) and COFEPRIS (Mexico) expect medical-device lots to travel with documented custody.
- Manufacturers must audit who moves product — custody becomes a switching cost.
- GDP / good distribution practice is the operational discipline behind that file.
- This is an entry ticket, not a linehaul discount.
- Trip file = lot + seal + temperature (if needed) + chain-of-custody + POD.
Related reading
Frequently asked questions
It is the closest sanitary counterpart for many device/drug controls — not a literal clone of every FDA program.
No. GDP/BPD is distribution quality practice; CTPAT is customs security partnership.
Who handled the lot, when, under what conditions, with which seals, and delivery integrity.
Changing movers can reopen the manufacturer’s audit — custody locks the relationship.
Assemble lot-level evidence on the trip ID; your team own regulatory judgment.