Medical devices checklist · Updated October 2026
Medical Device Traceability Checklist: 23 Checks for Indian Manufacturers (2026)
Medical device traceability means you can follow every unit or batch backward to its component lots, suppliers, operations and inspections, and forward to the customer it was shipped to. Indian manufacturers licensed under the Medical Devices Rules, 2017 rely on these records for audits, complaints and recalls. This checklist scores how ready your records are.
Who it is for: This checklist is for quality, production and operations heads at Indian medical device manufacturers with roughly ₹10–500 crore annual turnover.
Disclosure: Bsquare Solutions makes Pothera ERP, one of the options this guide discusses. We compare categories of ERP, not named vendors, and we say plainly where Pothera ERP is not the right fit.
Built by Bsquare Solutions Pvt. Ltd., Noida · part of The Nambiar Group · 25 years in business · 1,000+ manufacturing and trading clients.
Bsquare’s take
“Ask one question to test any device maker’s traceability: give me the list of customers who received devices built with this component lot. If the answer takes days, the quality system is working on goodwill, not records.”
The two directions of traceability
| Direction | Question it answers | Records needed |
|---|---|---|
| Backward | What went into this device, and who made and checked it? | Supplier lots, incoming inspection, device history record, calibration |
| Forward | Where did every device from this lot or batch go? | Dispatch by lot or serial and customer; installation and service history |
The checklist: 23 traceability checks
Answer each of the 23 checks for your plant today. Nothing you enter leaves your browser.
1. Design and device master
| Check | Your answer |
|---|---|
| 1. Each device has a controlled BOM and specification, with revision history | |
| 2. Engineering changes are approved, dated and effective from a known batch or serial | |
| 3. Inspection and test plans are defined for every product |
2. Suppliers and incoming material
| Check | Your answer |
|---|---|
| 4. Critical components come only from approved suppliers | |
| 5. Every incoming lot is recorded with supplier lot number and certificate | |
| 6. Incoming inspection results are recorded against the lot | |
| 7. Rejected lots are quarantined and cannot be issued |
3. Production records (device history)
| Check | Your answer |
|---|---|
| 8. Each batch or serial has a record of component lots used | |
| 9. Operations, operators and dates are recorded for each batch or serial | |
| 10. In-process and final inspection results are linked to the batch or serial | |
| 11. Equipment used is under current calibration, with records | |
| 12. Release is approved and recorded before dispatch |
4. Identification and labelling
| Check | Your answer |
|---|---|
| 13. Every finished unit or pack carries a lot or serial number | |
| 14. Labels are generated from the system, not typed by hand | |
| 15. Labelling meets the requirements that apply to your device class and markets |
5. Quality events
| Check | Your answer |
|---|---|
| 16. Non-conformances are recorded against the lot or serial | |
| 17. Corrective and preventive actions (CAPA) are tracked to closure | |
| 18. Complaints are linked to the device serial or lot | |
| 19. Changes to records leave an audit trail |
6. Distribution, service and recall
| Check | Your answer |
|---|---|
| 20. Every dispatch records lot or serial and customer | |
| 21. Installation and service history is held against the serial | |
| 22. You can list all customers for a component lot within hours | |
| 23. You have run a mock recall in the last 12 months |
How Pothera ERP supports traceability
- Lot and serial tracking from incoming component to dispatched device, with barcode-enabled stock.
- Device master and device history records, engineering change orders, non-conformance, CAPA and audit trails.
- Installation, complaints and service history by serial through Pothera CRM – Service X. See ERP for medical device manufacturers.
Frequently asked questions
What is medical device traceability?
Medical device traceability is the ability to follow each device or batch backward to its components, suppliers, production steps and inspections, and forward to the customers who received it.
What are the two main types of traceability?
Backward traceability links a device to its inputs — components, suppliers and production records. Forward traceability links a device or lot to where it was shipped, installed or serviced.
What are medical device traceability requirements in India?
Manufacturers licensed under the Medical Devices Rules, 2017 must run a quality management system meeting the Fifth Schedule, which includes identification and traceability. Licensing applies to Class A and B devices from 1 October 2022 and Class C and D from 1 October 2023.
What is a device history record?
A device history record is the production record for a batch or serial number: component lots, operations, inspections, labelling and release, showing it was made to its device master record.
How do you run a mock recall?
Pick a component lot, list every finished batch or serial that used it, then list every customer who received them. Time the exercise and note any step that needed paper or phone calls — those are your gaps.
Does this checklist confirm regulatory compliance?
No. It is a self-assessment of record-keeping readiness. Use the Medical Devices Rules, 2017, the standards that apply to your devices and your auditors to judge compliance.
Sources and methodology
This guide compares categories of ERP, not named products. The criteria come from Bsquare’s own implementations for Indian manufacturers and traders, the questions buyers ask most often in Google India search, and the official GST and MSME rules cited below. Compliance thresholds are taken from the government sources listed; check them against the current notification before you rely on them. Reviewed by the Bsquare implementation team.
Related
ERP for medical devices
Lot and serial traceability, DHR, NC and CAPA.
Asset Management & CMMS
Assets, maintenance, complaints and AMCs.
Manufacturing ERP glossary
Steel, cable, auto, medical devices, pharma and job-work terms.
ERP for pharma manufacturing
Batch records, QC, shelf life and traceability.
ERP demo questions checklist
35 questions to ask every vendor, with a free scoring tool.
All industries
Pothera ERP by industry.
Run a mock recall with us
Give us one component lot from a recent build. We will show the backward and forward trace in Pothera ERP.