Sri Lanka
1.2 Sri Lanka Regulatory Departments and Quality Control

Regulatory Authorities  

Function/ responsibilities

Ministry of Health, Food Control Administration Unit (FCAU)

FCAU (Food Control Administration Unit) is responsible for import control, domestic control of food and issuing export certificates for exporting food items according to the 1980 Food Act No.26.

Department of Imports and Export Controls

Responsible for issuance of import and export licenses for items subject to import and export control licenses including:

  • Issuance of import licenses for Pharmaceuticals;
  • Issuance of import licenses for Vehicles & Vehicle Parts;
  • Issuance of import licenses for Chemicals;
  • Issuance of import licenses for Communication Equipment;
  • Issuance of import licenses for Miscellaneous Items;
  • Debiting of Import Licenses;
  • Revision of Import and Export Licenses;
  • Gazetting of Standards.

The Department coordinates with the Sri Lanka Standards Institution in publishing specifications of standards relevant to such items.

Sri Lanka Standards Institute Sri Lanka Standards institute (SLSI)

SLSI plays an integral role with the FCAU and in formulation of National Standards under the Food Act. The Standards of the SLSI are mostly voluntary. Some of them are declared mandatory for verification of standard parameters at the point of import. The SLSI has mutual agreements with standards setting bodies of the exporting countries that certify the products exported from selected countries. Based on the certification of those bodies and verification checks carried out at national level the SLSI releases those products for further inspection and verification of FCAU. SLSI licenses the following items as of 10.2020:

SLSI License Items 1
SLSI License Items 2
SLSI License Items 3

National Drug Regulatory Authority

The National Medicines Regulatory Authority (NMRA) plays a leading role in protecting and improving public health by ensuring medicinal products available in the country meet applicable standards of safety, quality and efficacy. The Authority regulates medicines, medical devices, borderline products, clinical trials and cosmetics. The National Medicines Quality Assurance Laboratory (NMQAL), charged with ensuring quality of medicinal products, also functions under the purview of the NMRA.

Sri Lanka Telecommunication Regulatory Commission

  • Processing applications for the following licenses:
    • Licenses to operate telecommunication systems in Sri Lanka under Section 17 of the Act;
    • Licenses for use of radio frequency and radio frequency emitting apparatus under section 22 of the Act;
    • Licenses to operate a private network under Section 20(ii) of the Act;
    • Licenses for cabling works under Section 22A (1) of the Act.
  • Formulate pricing policies;
  • Monitoring and ensuring compliance with the Act (including rules and regulations made there under) and licenses by the licensed operators;
  • To monitor and ensure proper utilization of the radio frequency spectrum;
  • Providing information to the public on quality and variety of telecommunication services and encourage their participation by conducting public processes and public hearings.

Atomic Energy Regulatory Council of Sri Lanka

Protection of the general public, the radiation workers, patients and the environment from potentially harmful effects of ionizing radiation. Including:

  • Control and observation for the prevention of nuclear or radiological emergencies;
  • Cooperate with local and international organizations;
  • Inspect, review and assess practices and facilities;
  • Issue directives relating to corrective measures if unsafe or potentially unsafe conditions are detected at any location;
  • Grant approval to institutes or individuals involved in issuing certification on radiation measurement and calibration of radiation measuring equipment;
  • Conduct public awareness programmes on safety, security and emergency.

Consumer Affairs Authority (CAA)

Consumer Affairs Authority (CAA) is the apex government organization mandated to protect consumers’ interests and ensure fair market competition in Sri Lanka. It has been established under the Consumer Affairs Authority Act No.09 of 2003. The act has laid down the legal provisions empowering the CAA to take necessary actions to safeguard the interests of consumers while maintaining effective competition among suppliers of goods and services.

For more information on regulatory departments and quality control laboratories’ contact details, please see the following links: 4.1 Government Contact List and 4.3 Laboratory and Quality Testing Company Contact List.


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