Sri Lanka Medical Device Advertising: NMRA Pre-Approval and Content Restrictions

Sri Lanka Medical Device Advertising: NMRA Pre-Approval and Content Restrictions

Advertising and promotional activities for medical devices in Sri Lanka are tightly controlled by the National Medicines Regulatory Authority (NMRA), specifically through its Advertising Evaluation Sub Committee. Unlike many jurisdictions, a formal pre-approval process is mandated for all promotional materials.

---

Mandatory Pre-Approval Requirement

Any form of communication—written, printed, spoken, or visual—that directly or indirectly promotes the manufacture, sale, or disposal of a medical device is considered an advertisement under NMRA rules.

• Prior Written Approval: Prior written approval from the NMRA is mandatory before any advertisement may be published, broadcast, or otherwise used.
• Review Process: Applications are reviewed by the Advertising Evaluation Sub Committee, which typically meets once a month. The process requires a comprehensive submission package and a processing fee of approximately USD 1,000.

Restrictions on Public Advertising

The NMRA enforces strict ethical and accuracy standards. A major restriction concerns the target audience and the claims made:

• Prohibited Public Promotion: Products must not be advertised or promoted to the general public for the treatment, prevention, or cure of any diseases, disorders, or abnormal physical states prescribed by regulation.
• Scope: The Sub Committee ensures that all commercials, infomercials, and public service announcements comply with NMRA guidelines, verifying that claims are substantiated by supporting documents (e.g., clinical data, test reports).

---

Advertising Application Procedure

Applicants must follow a structured procedure for submitting an advertisement for approval:

1. Submission: Submit the completed application form, a copy of the valid registration certificate, and a storyboard of the advertisement.
2. Payment: Obtain a payment note and pay the processing fee (approx. USD 1,000).
3. Dossier Submission: Submit the final file, including the payment receipt, signed application, registration certificate(s), three printed sets/storyboard, and two CDs if the ad includes audio or video.
4. Review and Collection: After the committee review, evaluation reports are sent via email, and the final approval letter is collected at the NMRA issuing counter.

Mandatory Content in Advertisements

When designing advertising materials, applicants should ensure the following information is clearly included, where applicable:

• Active ingredient(s) or generic name (must be prominently displayed).
• Any special warnings relevant to the product.
• Therapeutic claims (if applicable and approved).
• Price of the product.