Enforcement & Compliance
NMRA · NMRA Act No. 5 of 2015 · Market Control Division
Overview
The NMRA has broad enforcement powers under the NMRA Act No. 5 of 2015 to ensure that medical devices on the Sri Lanka market are safe, effective, and properly registered. Enforcement is conducted primarily by the Market Control Division (MCD) of the NMRA.
Market Control Division (MCD)
The Market Control Division oversees post-market compliance through:
- Market surveillance: Ongoing monitoring of devices available on the Sri Lanka market
- Establishment inspections: Inspections of MAH premises, importers, distributors, and warehouses
- Product sampling and testing: Sampling devices from the market for quality and safety testing
- Complaint investigation: Investigating reports from healthcare professionals and the public about non-compliant or unsafe devices
- Import monitoring: Coordination with Sri Lanka Customs to identify non-registered devices at ports of entry
Enforcement Actions Available to NMRA
| Action | Description |
|---|---|
| Written warning | Initial notice of non-compliance; requires corrective action within a specified timeframe |
| Registration suspension | Temporary suspension of device registration pending investigation or corrective action |
| Registration cancellation | Permanent cancellation of device registration for serious or persistent violations |
| Product seizure | Physical seizure of non-compliant, unregistered, or substandard devices from the market |
| Condemnation and destruction | Destruction of seized devices that pose a safety risk |
| Licence suspension / cancellation | Suspension or cancellation of MAH or importer licence |
| Prosecution | Criminal prosecution of responsible persons for serious violations |
| Public advisory | NMRA publication of safety alerts or public notices about non-compliant devices |
Penalties Under the NMRA Act
The NMRA Act No. 5 of 2015 provides for:
- Financial penalties for regulatory violations — amounts specified in the Act and subordinate legislation
- Imprisonment of responsible persons for serious offences (including supply of unregistered devices, falsification of registration documents)
- Court orders requiring recall, withdrawal, or disposal of non-compliant products
Priority Enforcement Areas
NMRA enforcement priorities for medical devices include:
- Unregistered devices: Supplying devices that require registration (risk Class I, IIa, IIb, III) without NMRA approval
- Non-compliant labelling: Devices without required English/Sinhala/Tamil labelling or missing mandatory label elements
- Substandard devices: Devices that fail to meet their claimed specifications
- Counterfeit devices: Fraudulent imitation of registered devices
- False advertising: Device claims not supported by registration or clinical evidence
Cooperation With NMRA Inspectors
When NMRA inspectors visit an establishment:
- Cooperate fully — obstruction is an offence
- Provide requested records (registration documents, distribution records, complaint logs) promptly
- Designate a responsible person to accompany inspectors
- Document the inspection, including any samples taken and notices issued
Responding to Enforcement Actions
If NMRA issues a non-compliance notice or enforcement action:
- Acknowledge receipt in writing within the specified timeframe
- Engage a regulatory affairs professional or legal advisor experienced in NMRA matters
- Prepare a CAPA response addressing all cited deficiencies with evidence of implementation
- Request NMRA guidance on compliance restoration if unclear
- Do not resume distribution of suspended products without written NMRA clearance
Whistleblower Reporting
Healthcare professionals, patients, and others may report concerns about unsafe or non-compliant devices directly to the NMRA. NMRA investigates such reports and maintains confidentiality of the reporter where appropriate.
Import Interception — Sri Lanka Customs
NMRA coordinates with Sri Lanka Customs to intercept shipments of unregistered or non-compliant medical devices at ports of entry. Importers should ensure:
- All imported devices are covered by a valid NMRA registration before shipment
- Import documentation includes the NMRA registration number
- Labelling of shipments matches the NMRA registration