Overview
In Sri Lanka, National Medicine Regulatory Authority (NMRA), under the Ministry of Health (MoH), is responsible for regulation and control of registration, Licencing, manufacturing, importation, and other aspects pertaining to medical devices. Under the NMRA there are sub- divisions which take up the task for labeling approval and advertisement. Medical Device Evaluation Committee (MDEC) within the NMRA evaluates the medical devices applications and oversees Sri Lanka Medical Device Registration.
The NMRA regularly updates the guidelines with current situation and technical requirements and evaluates the policy process in line with GMP.
Sri Lanka Medical Device Classification
As on November 2020, there are no specific classification rules in effect for Medical Devices. NMRA has however, released a draft guideline in October 2019, which is expected to be in effect at any time. As per the new guidelines, Medical Devices are classified into five (5) Classes and In-Vitro Diagnostic (IVDs) devices are classified into four (4) 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 |
Sri Lanka Medical Device Registration
The pathway towards launch of a device in Sri Lankan market is a three 3-phased process that includes:
Import License for 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 the Local Agent in e-NMRA portal.
- Manufacturers of Class IIb, III and Class D IVDs shall submit 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: Submit 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 to external evaluation along with the samples.
Step 3: Import License
- Manufacturer, through the Local Agent, shall apply for import license once the device registration is obtained.
Key Notes
- In case of devices with multiple components, different applications shall be submitted for individual component and each of them should be registered separately.
- A medical device consisting a collection of devices and has a common intended purpose or 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 year.
Product maintenance & compliance
Validity
Sample licence will be issued in three (3) copies and will be valid for one (1) year from issuing date.
The Medical Device registration licence is valid up to five (5) years.
Renewal
The registered medical device should be renewed before six (6) months from the date of expiry of registration.
Post Approval Changes
Any changes of 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 Licence 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
