Labelling & Advertising
NMRA Act §77 · Prior advertising approval · LK-Unique monthly committee review
Labelling Requirements — NMRA Act Section 77
All NMRA-registered devices must carry labelling complying with Section 77 of the NMRA Act No. 5 of 2015.
Minimum Label Contents
| Element | Requirement |
|---|---|
| Device name / trade name | Required |
| Manufacturer name and address | Required — full legal name |
| MAH name and address | Required — Sri Lanka contact |
| Lot / batch number | Required |
| Manufacturing date | Required |
| Expiry date | Required where applicable |
| Intended purpose | Required where not obvious |
| Warnings and precautions | Required for safety-critical information |
| Storage conditions | Required where specific conditions apply |
| Single-use symbol | Required where applicable |
Primary and Secondary Labels
NMRA requires both primary (directly on device/smallest packaging) and secondary (outer packaging) labels to contain the approved device name, manufacturer, MAH, and other required information. The primary and secondary labels must be consistent with the labelling approved during registration.
IFU (Instructions for Use)
- Must accompany the device unless the label alone provides sufficient information for safe use
- Must be comprehensive: intended purpose, indications, contraindications, warnings, adverse effects, performance characteristics, maintenance, disposal
- Must be accurate and consistent with the approved registration
Device Advertising — Prior Written Approval Mandatory — LK-Unique
One of the most distinctive features of Sri Lanka's framework: All advertising for NMRA-registered medical devices requires prior written approval from the NMRA before publication or broadcast. This requirement is explicitly provided in the NMRA Act.
What Counts as Advertising?
Any promotional communication about an NMRA-registered medical device, including:
- Print advertisements (journals, magazines, newspapers)
- Online and digital advertising
- Television and radio commercials
- Promotional materials distributed to healthcare professionals
- Website product pages with promotional content
- Social media promotional posts
- Direct mail campaigns
Advertising Evaluation Sub Committee — LK-Unique
Advertising applications are reviewed by the NMRA Advertising Evaluation Sub Committee, which meets monthly. The committee reviews the content for accuracy, truthfulness, and consistency with the approved registration.
Timeline implication: Plan your advertising development and approval process with a lead time of at least 4–8 weeks before intended publication, accounting for the monthly review cycle.
Prohibited Advertising Claims
- Claims that exceed the approved intended purpose
- Misleading or exaggerated claims about device performance
- Promotion of devices to the general public for treatment of specified diseases/disorders (prescription-type devices should only be promoted to healthcare professionals)
- Claims that have not been validated in the registration dossier
Post-Approval Labelling Changes
Any significant change to device labelling after registration must be notified to the NMRA and approved before implementation. Significant changes include:
- Changes to the device name or trade name
- Addition or deletion of warnings
- Changes to the approved intended purpose or indications
- Changes to storage conditions