Sri Lanka IVD Classification: Class A to D

1. Key takeaways

The root of the Sri Lankan arrangement, in which IVDs use Class A to D and general devices use Class I to III, lies in the fact that the country overall follows the European Union tradition of two separate pieces of legislation with two separate classifications: general devices are classified into four classes (I / IIa / IIb / III) under the classification principles and rules of the EU medical device legislation, while IVDs are classified separately into four letter classes (A / B / C / D). This design is stated explicitly in GL-037 and is cross-repeated in the eligibility conditions of the NMRA low-risk pathway. Understanding the logic of the two systems matters operationally, because the risk questions asked of an IVD are not the questions asked of a general device, and the dossier elements differ accordingly. A project team that identifies the correct system at the start avoids class naming errors in every downstream document, from the application form to the labelling review.

• General devices are classified under the classification principles and rules of the EU medical device legislation.
• IVDs use a separate letter scale from Class A to Class D.
• The two systems are mutually exclusive and are referenced separately in the low-risk pathway conditions.
• IVDs submitted as combined dossiers require performance evaluation test reports, both analytical and clinical.
• The definition of general devices, as products other than IVDs, comes from GL-034.

2. Legal basis

The table below collects the sources for each element of the dual classification arrangement, from the classification basis for general devices to the additional evidence required for IVDs submitted as combined dossiers.

3. Expert insights

Insight 1: the risk logic of IVDs differs from that of general devices. For general devices, risk arises mainly from the mode of contact and the degree of invasiveness; for IVDs, risk arises mainly from the clinical consequences of the test result, for example the consequences of an error in blood screening for transfusion or in testing for infectious disease. This is the technical reason why two classification systems coexist in one framework. A scale built around invasiveness and contact duration cannot express the differences between a screening assay whose failure affects the blood supply and a simple qualitative test, so the letter scale is used instead. Teams that apply device-style risk reasoning to IVD projects misjudge both the class and the evidence expectations, so the two logics should be kept clearly separate in planning documents.

Insight 2: the low-risk pathway is open to IVDs only at Class A. GL-037 is explicit: the listed low-risk scope covers listed devices, Class I general devices and Class A IVDs, and only where they are non-sterile, non-active and without a measuring function; Class B, C and D IVDs do not qualify. The great majority of IVD products therefore cannot use the low-risk pathway, since most diagnostics fall above Class A or carry one of the disqualifying characteristics. IVD project plans should be built on the assumption of the full registration route unless the Class A and product-characteristic checks have both been passed, and the plan should be revised only after those checks are documented. Treating the pathway check as a formal gate, rather than as an assumption, keeps the timeline credible in front of the client.

Insight 3: the IVD dossier carries its own additional documents. An IVD submitted as a combined dossier must include performance evaluation test reports, both analytical and clinical. These belong to a different document series from the specialised requirements applied to general devices, such as electrical safety or sterilisation validation, and cannot be substituted by them. Preparing the two streams with the same template set is a common cause of deficiency letters, so the IVD evidence stream should be planned as its own workstream with its own owners, its own laboratory arrangements and its own timeline running alongside the general dossier elements.

4. Practical recommendations

• The advice given to IVD clients is direct: first confirm whether the product is Class A, because that single determination decides whether any simplified route exists at all.
• If the product is not Class A, prepare for the full PRD route and build the plan accordingly, without assuming that pathway shortcuts will become available later.
• Plan in parallel the timeline for the Sample Import Licence (SIL) and the submission of samples for testing, so that sample logistics do not become a late discovery.
• Recognise in the project schedule that the bottleneck of an IVD project is usually not the review itself but the sample testing stage, and sequence other preparation work around that constraint.
• Document the class determination and the evidence list before dossier drafting starts, so that the performance evaluation reports are commissioned early enough to arrive before submission.

5. Verification checklist

• □ It has been confirmed whether the product is a general device or an IVD.
• □ The IVD has been assigned to Class A / B / C / D.
• □ If Class A, it has been checked whether the product is non-sterile, non-active and without a measuring function.
• □ Performance evaluation test reports (analytical and clinical) have been prepared.
• □ The schedule for sample import and testing has been arranged.

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