AUTHORIZED REPRESENTATIVE (MEDICAL DEVICES - SRI LANKA)

REGULATING MEDICAL DEVICES

Medical Devices in Sri Lanka are regulated by the National Medical Regulatory Agency (NMRA).

As of November 2023, no final version nor further revisions to this draft guidance have been published, nor has the NMRA indicated a timeline for implementation of the guideline. Thus, there is currently a classification system for medical devices implemented in Sri Lanka. The current registration system has the same documentary requirements for all medical devices.

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