NABH Medical Equipment Requirements: A Checklist for Hospitals
Getting ready for NABH, or buying for a hospital that will apply? This guide shows what the new rules ask for medical devices, the records to keep, and what to get from your supplier on day one.
NABH's 6th edition rules, in force since 1 January 2025, deal with medical devices in FMS.5. It has eight parts: a plan, a device list with logs, a service plan, checks and calibration, trained staff, rules to retire old devices, action on recalls and device faults, and a record of how long key devices are out of use.
What NABH Asks For
NABH is the national body that accredits hospitals in India. It released the 6th edition of its hospital rules in September 2024, and they have applied since 1 January 2025. Medical devices sit in the chapter on facility safety (FMS), under FMS.5. Here is what each part asks for.
| FMS.5 element | What it means | Proof to keep |
|---|---|---|
| 5a. Planning | Choose equipment to match the services you offer | Equipment plan; purchase committee minutes |
| 5b. Inventory and logs | Know every device you own and its history | Inventory list; a log or history sheet per device |
| 5c. Operation and maintenance plan | Planned preventive and breakdown maintenance | PM schedule, PM checklists, breakdown plan |
| 5d. Inspection and calibration | Check that devices measure and work correctly | Calibration certificates, schedule and labels |
| 5e. Qualified and trained staff | Users and service staff know the equipment | Training records; biomedical staff qualifications |
| 5f. Replacement and disposal | Written rules for when and how to retire devices | Condemnation policy and disposal records |
| 5g. Adverse events and recalls | Act on recall notices and report device problems | Recall file; adverse event reports |
| 5h. Downtime of critical equipment | Track how long critical devices are out of use | Complaint register with start and end times |
A hospital training summary marks 5c as a core part and 5h as a higher-level part. Each hospital must name its own list of key devices. Examples include ventilators, anaesthesia machines, monitors, the cath lab, CT, MRI, ultrasound and lab machines.
Records Checklist
A biomedical team checklist for NABH lists these records. Keep them for every device:
- Purchase papers: the bill, the licence, the quality mark and the maker's test report.
- Log: the date you bought it, each service and check, each upgrade and each spare part fitted.
- Planned service: a schedule that you follow, and a checklist used at each visit.
- Repair plan: who checks a broken device and who fixes it, under warranty, AMC or CMC.
- Calibration: a report, a schedule, and a label on the device with the last and next dates.
- Training: a record of who was trained on each device and how to use it safely.
- Complaints: a register with the time each fault was reported, seen and fixed.
- Contracts: a list of which devices are under warranty, AMC or CMC.
The same checklist asks for a set time to respond to faults, with ICU and OT first, and help at any hour for key devices.
Buying equipment for an NABH hospital?Get a written quote, brochure or demo from the Pulse team.
Adverse Events and Recalls
India tracks harm from medical devices through a national programme called MvPI. It started on 6 July 2015. Since January 2018, the Medical Device Rules 2017 have required hospitals and makers to report such harm.
New MvPI advice, reported in September 2026, asks hospitals to report serious harm, such as a death, within 15 days. Other faults should be reported within 30 days, even before the cause is clear. Each hospital should name one person to lead this. Under NABH 5g, a recalled device must not be used on patients until the fault is fixed.
What to Ask Your Supplier
Most of these records start on the day a device arrives. Ask every supplier for:
- The CDSCO licence, quality marks and the maker's test report.
- A calibration report when the device is set up, and a schedule for the next ones.
- The maker's service schedule and checklist.
- Training for your staff on day one, with a signed list of who came.
- User and service manuals.
- A written promise to tell you about recalls and safety alerts.
- How fast they will respond, how much uptime they promise, and spare parts after the warranty.
To compare the cost of AMC and CMC contracts, see our after-sales service guide.
Pulse Support for NABH Hospitals
Pulse plans what each department needs, supplies the devices, sets them up, trains your staff and looks after service once you open. Ask for set-up, calibration and training records with every delivery, so your NABH files are complete from day one. See Pulse Service and Support and our hospital setup checklist.
NABH Medical Equipment Requirements: Key Facts
- NABH's 6th edition hospital rules have applied since 1 January 2025.
- Medical devices fall under FMS.5, which has eight parts, from planning to tracking downtime.
- Every device needs a log, a service schedule, calibration records and a calibration label.
- Since 2018, Indian law requires harm from medical devices to be reported to the national MvPI programme.
- New 2026 advice asks hospitals to report serious device harm within 15 days.
NABH Medical Equipment Requirements: FAQs
What are the NABH requirements for medical equipment?
Under the 6th edition, FMS.5 asks for a plan, a list of every device with its log, a service plan, checks and calibration, trained staff, rules to retire old devices, action on recalls and faults, and a record of downtime for key devices.
Which NABH chapter covers medical equipment?
The chapter on facility safety, called FMS. In the 6th edition, FMS.5 covers medical devices.
What records does NABH need for each device?
Keep the purchase papers, a log, the service schedule and checklists, calibration reports and a calibration label, training records, a fault register and the warranty, AMC or CMC status.
When did the NABH 6th edition start?
NABH released the 6th edition hospital rules on 17 September 2024. They have applied since 1 January 2025.
Do hospitals have to report medical device adverse events?
Yes. Since 2018, the Medical Device Rules 2017 have required harm from devices to be reported to the national MvPI programme. New 2026 advice asks for serious harm to be reported within 15 days.
Can Pulse help with NABH equipment records?
Yes. Pulse sets up and services its devices and trains your staff. Ask for set-up, calibration and training records with every delivery. Message +91 90711 01108 to talk about your project.
Sources
- Notification: Implementation Plan of 6th Edition NABH Accreditation Standards for Hospitals (NABH, 10 September 2024): release and effective dates
- NABH 6th Edition: FMS chapter training notes (hospital training site): FMS.5 objective elements, critical equipment, recalls, downtime
- Checklist of biomedical engineering department for NABH preparation (RelyHealthTech, accessed November 2026): records and policies
- Materiovigilance Programme of India (National Health Systems Resource Centre): launch, IPC role, Medical Device Rules 2017 reporting
- Hospitals face stricter medical device reporting rules (OC Academy, 22 September 2026, citing IPC and ETHealthWorld): 15-day and 30-day reporting timelines
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