Technical Documentation
NMRA · F-MDR-035 · Essential requirements · ISO 13485 · ISO 14971
Essential Requirements Compliance
All devices registered with the NMRA must demonstrate compliance with NMRA essential requirements for safety and performance. These are broadly aligned with EU Medical Device Directive essential requirements and cover:
General Requirements
- Device is designed and manufactured to be safe when used as intended and as reasonably foreseeable
- Known and foreseeable risks minimised; benefits outweigh residual risks
- Performance claims substantiated
Design and Construction Requirements
| Requirement Area | Key Standards |
|---|---|
| Chemical, physical, biological properties | ISO 10993 series (biocompatibility) |
| Infection and microbial contamination | ISO 11135, 11137, 17665 (sterilisation as applicable) |
| Construction and environmental properties | IEC 60601-1 (active devices), relevant performance standards |
| Devices with measuring functions | Accuracy and precision requirements |
| Radiation protection | AEA Act requirements (radiation-emitting devices) |
| Active devices — energy sources | IEC 60601-1 series |
| Software | IEC 62304, IEC 62366 |
ISO 13485 — QMS Certification
All Class I, IIa, IIb, and III devices require ISO 13485 certification of the manufacturer:
- Certificate from an internationally accredited certification body
- Scope covering the specific product category
- Current at time of submission (not expired)
- Covers the manufacturing site where the device is produced
ISO 14971 — Risk Management
Every device registration dossier must include a risk management summary:
- Hazard identification for the specific device in its intended use context
- Risk estimation for each identified hazard
- Risk control measures implemented
- Residual risk evaluation
- Benefit-risk analysis confirming benefits outweigh residual risks
The full ISO 14971 risk management file is held by the manufacturer; the dossier includes a comprehensive summary report.
Documentation Depth by Class
| Class | Documentation Expectation |
|---|---|
| Listed/I | Core essential requirements compliance; basic risk management; abbreviated CER for well-established technologies |
| IIa | Standard essential requirements checklist; clinical evaluation with literature review; ISO 13485 |
| IIb | Detailed clinical evaluation report; full risk management; MDEC review — prepare for deeper scrutiny |
| III | Comprehensive clinical data; rigorous CER; full design history; MDEC review |
Local Testing Requirements — LK-Unique
Certain device categories require physical testing to be conducted locally in Sri Lanka as part of the registration process. This is a distinctive NMRA requirement:
| Device Category | Local Testing Required |
|---|---|
| Devices that come into direct contact with the blood stream | ✅ Yes |
| Latex products — condoms | ✅ Yes |
| Latex products — surgical gloves | ✅ Yes |
| Latex products — examination gloves | ✅ Yes |
| Latex products — bandages with latex content | ✅ Yes |
| Feeding bottles | ✅ Yes |
| Toothbrushes | ✅ Yes |
| Medical gas cylinders | ✅ Yes |
To conduct local testing, a Sample Import Licence must be obtained before the samples can enter Sri Lanka. Budget the time and cost for local testing into your overall registration planning.
In ISO 13485 section, add: 'The certification body must be accredited to ISO/IEC 17021 standards and recognized by the NMRA. Confirm acceptability of your certification body with the NMRA before submission if using a less common auditor.'