According to the National Medicines Regulatory Authority Act No. 05 of 2015 the National Medicines Regulatory Authority shall be responsible for the regulation and control of registration, licensing, manufacture, importation and all other aspects pertaining to medical devices in a manner compatible with the National Medicines Policy;
Definition of a medical device:As defined in the Act a “medical device” means any instrument, apparatus, appliance, software, material or any other article, whether used single or in combination, including the software necessary for its proper application intended by the manufacturer used in or on human beings for the purpose of:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease;
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;
- Investigation, replacement or modification of the anatomy or of a physiological process;
- Control of conception;
and which does not achieve its intended action in or on the human body by pharmacological, immunological or metabolic means but which may be assisted in its function by such means;
A medical device does not include an Ayurveda device or a Homeopathy device;
Scope and Responsibilities of the NMRA in the approval of medical devicesThe National Medicines Regulatory Authority (NMRA) is responsible to build a healthier nation by ensuring that medical devices available for supply in Sri Lanka are of acceptable quality, safety and fit for their intended purpose. As such all Medical devices which are categorized as in above definition and should be registered with the Authority and license to be obtained for manufacturing, importation, re-packaging, sale, distribution and offered for sale in Sri Lanka.
All foreign medical device manufactures should submit application for registration through a Marketing Authorization Holder (local agent) in Sri Lanka who shall be responsible for the registration, licensing, importation, sale and distribution, handing of quality failures and all aspects pertaining to the particular medical device in Sri Lanka.
The Medical Device Evaluation Committee (MDEC) formed under NMRA Act carries out technical evaluation of the medical devices forwarded for registration by considering the quality, safety, effectiveness, need and cost of such devices. The MDEC consist of experts drawn from various specialties in medical and pharmaceutical fields who meets monthly to decide on applications submitted for marketing authorization of medicines and to make policy decisions relevant to marketing authorization of medicines.