Sri Lanka Borderline Products and Device Determination

1. Key takeaways

Borderline products in Sri Lanka are products that sit in the grey zone between medicines, medical devices and cosmetics, and that require a determination of which regulatory category applies to them. NMRA provides a clear entry point for this determination, the Product Categorization Letter (PCL) procedure, associated with forms F-MDR-044 (application form), F-MDR-043 (checklist) and F-MDR-042 (acknowledgement). In addition, the NMRA website publishes a list of products that NMRA considers not to fall under medical device jurisdiction. The combination of an official determination procedure and an official exclusion list means that the classification of a borderline product does not need to rest on the applicant’s own interpretation: the channels for obtaining an authoritative answer exist, and they should be used before dossier preparation begins rather than after a deficiency letter arrives. For products that combine features of several categories, or whose intended purpose can be read in more than one way, the determination is the step on which every later decision depends, from the dossier structure to the fee schedule to the review body that will handle the file.

• Borderline products span the space between medicines, devices and cosmetics.
• The official determination channel is the Product Categorization Letter (PCL) procedure.
• The PCL procedure uses forms F-MDR-044, F-MDR-043 and F-MDR-042.
• NMRA publishes an official list of products it considers outside device jurisdiction.
• Ayurveda and homeopathy devices are excluded from the device definition by statute.

2. Legal basis

The table below collects the sources for each element of the borderline product framework: the existence of the category, the determination procedure, the three associated forms, the official exclusion list, and the statutory exclusions rooted in the device definition.

3. Expert insights

Insight 1: borderline status is not a grey zone through which products can pass freely; it is a status that must be determined before action. The fact that NMRA provides both the PCL procedure and the exclusion list shows that the responsibility for the determination rests with the applicant and that the channel for making it is ready at hand. Skipping this step and filing directly as a device, or filing directly as a non-device, places the entire risk on the applicant. If the category chosen is wrong, the dossier is built on the wrong foundation, the review either rejects it or redirects it, and the time invested in preparation is lost. Because the procedure exists precisely for this situation, an applicant who does not use it has chosen to carry a risk that the authority has already offered to remove.

Insight 2: the exclusion list is a dynamic official position, not industry speculation. The NMRA website expressly sets out the products that the authority considers not subject to device regulation. Citing this list is more reliable than citing any third-party interpretation, because it reflects the authority’s own current view of its jurisdiction. The list can change as the authority updates its position, which means that the check against the list should be repeated for each project, and the version consulted should be recorded. Where a product appears on the list, the device route is closed and the relevant alternative track must be identified; where it does not appear and the classification remains uncertain, the PCL procedure is the proper next step. In both situations the official source, rather than a consultant’s opinion or a competitor’s precedent, is what should be recorded in the project file as the basis of the decision.

Insight 3: traditional medicine devices are expressly excluded, and this is the first sieve in the determination. If the product belongs to the Ayurveda or homeopathy systems, it follows a separate body of rules and the device route does not apply. This exclusion is statutory, written into the device definition itself, and therefore outranks any argument that the product resembles a conventional device in form or function. Checking the traditional medicine exclusions before any other classification work saves the effort of building a device dossier for a product that the statute places outside the track altogether, and it directs the project toward the correct regulatory counterpart from the first day.

4. Practical recommendations

• The working method is to make the PCL part of the project start-up package: first submit the PCL and obtain the official classification letter, then determine the route and the dossier structure on the basis of that letter, and only then invest in technical documentation.
• This sequence avoids the loss of discovering, after the documentation is finished, that the category was determined wrongly from the start.
• Check the NMRA exclusion list on the NMRA website at the moment of the determination, and record the version and date consulted in the project file.
• File the PCL application form (F-MDR-044) with the checklist (F-MDR-043) attached, and retain the acknowledgement (F-MDR-042) once received.
• Where the product may belong to the Ayurveda or homeopathy systems, resolve that question first, before any device-track work is commissioned.

5. Verification checklist

• □ It has been judged whether the product is a borderline product.
• □ If it is a borderline product, the PCL application (F-MDR-044) has been submitted.
• □ The PCL checklist (F-MDR-043) has been attached.
• □ The PCL acknowledgement (F-MDR-042) has been obtained and retained.
• □ The NMRA exclusion list on the official website has been checked.

Regulatory information verified as of 28 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including Sri Lanka. Our team prepares dossiers to NMRA expectations, manages submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com