Medical Device Regulatory Support in Sri Lanka

Overview

In Sri Lanka, the National Medicine Regulatory Authority (NMRA), under the Ministry of Health (MoH), is responsible for the regulation and control of registration, licensing, manufacturing, importation, and other aspects pertaining to medical devices. Under the NMRA, there are sub-divisions that take up the task of labeling approval and advertisement. The Medical Device Evaluation Committee (MDEC) within the NMRA evaluates the medical device applications and oversees the Sri Lankan medical device registration.

The NMRA regularly updates the guidelines per the current situation and technical requirements and evaluates the policy process in line with GMP.

Medical Device Classification

As of November 2020, there are no specific classification rules in effect for medical devices. The NMRA has, however, released a draft guideline in October 2019, which is expected to come into effect any time. As per the new guidelines, medical devices are classified into five (05) Classes, and In-Vitro Diagnostic (IVDs) devices are classified into four (04) Classes. Grouping of devices is feasible in Sri Lanka.

Medical Devices

Device Risk

Listed Medical Device

Lowest risk

Class I

Low risk

Class IIa

Medium risk

Class IIb

Medium High (Moderate) risk

Class III

High risk

IVD

Risk

Class A

Low individual and public health risk

Class B

Moderate individual and low public health risk

Class C

High individual and moderate public health risk

Class D

High individual and public health risk


Medical Device Registration

The pathway towards the launch of a device in the Sri Lankan market is a three (03)-phased process that includes:

Import License for the importation of commercial consignments

Medical Device Registration: Sample Import License; Sample importation and Testing; Device Registration Application and License

Appointment of Local Agent and Manufacturing Site Registration

Step 1: Manufacturing Site Registration:

  • Foreign manufacturers shall appoint and register a local agent in the e-NMRA portal.
  • Manufacturers of Classes IIb, III, and Class D IVDs shall submit the Site Master File (SMF) documents.

Step 2: Medical Device Registration:

  • Sample Import License Application: Request letter for registration, business registration certificate BR (1), and a copy of free sales shall be submitted along with the application.
  • Device Registration: Manufacturers have to submit an application for device registration along with the registration sample. Applications are subjected to basic evaluation by internal evaluators. If the application is in order, it is further pushed towards an external evaluation along with the samples.

Step 3: Import License

  • The manufacturer, through the local agent, shall apply for an import license once the device registration is obtained.

Key Notes

  • In the case of devices with multiple components, different applications shall be submitted for individual components, and each of them should be registered separately.
  • A medical device consisting of a collection of devices that have a common intended purpose or an IVD consisting of reagents or articles to be used in combination for a specific intended purpose can be registered as a group.
  • Under certain circumstances, provisional registration will be granted for a maximum period of one (01) year.

Product Maintenance & Compliance

Sl. No

Validity

Renewal

Post Approval Changes

01

A sample license will be issued in three (03) copies and will be valid for one (01) year from issuing date.

The Medical Device registration license is valid for up to five (05) years.

The registered medical device should be renewed before six (06) months of the date of the expiry of registration.

Any changes to the registered medical device should be sent to the NMRA with relevant documents.

Freyr Expertise

  • End-to-end Medical Device Registration
  • Medical Device Compliance in Sri Lanka
  • Authorized Local Agent
  • Manufacturing Site Registration
  • Sample Import License Support
  • Application Submission to the NMRA
  • Query Support Management till Approval
  • Post-Approval Device Life Cycle Management
  • Import License for Commercial Imports
  • Artwork Management
  • Labeling Management
  • Translation Services

Location

No. 724, 7th Floor, Janajaya City, Rajagiriya, Colombo, Sri Lanka

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