Authorized Representative for Medical Devices – Sri Lanka
Medical devices in Sri Lanka are regulated by the National Medical Regulatory Authority (NMRA). Non-local manufacturers must appoint a local Authorized Representative (AR) to comply with regulatory requirements and facilitate product registration.
As of November 2023, the NMRA has not published a final version of its draft guidance or indicated a timeline for updates. Currently, a classification system exists for medical devices, and the registration process applies the same documentary requirements to all device categories.
A qualified Authorized Representative helps manufacturers navigate NMRA registration procedures, manage documentation, and maintain compliance, enabling medical devices to enter the Sri Lankan market efficiently and legally.
LOCAL REPRESENTATIVE
Non-local manufacturers shall have a local representative known as a Marketing Authorisation Holder (MAH). The MAH is responsible for registration, importation and sale and distribution, including vigilance activities. They can be considered the “owner” of the registration.
The Name and Address of the importer shall be identified on the labelling.
QUALITY SYSTEM REQUIREMENTS
Iso 13485 is recognised, however, the NMRA specify that local and non-local manufacturers must meet World Health Organisation (WHO) Good Manufacturing Principles (GMP).
THE QMS MUST CONTAIN THE FOLLOWING REQUIREMENTS
- Description of the interaction of processes as well as organisation chart
- Release procedure for finished products
- Supplier management
- Quality risk management
- Premise and equipment management
- Validation
- Quality control
- Distribution, complaints, product defects and recalls
- Auditing