All medical devices are regulated by the Ministry of Health (MoH) via the Registration and Drug Control Department
Medical Device Definition
"Medical device" means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article (a) intended by the manufacturer to be used alone or in combination for human beings for one or more of the specific purpose(s) of diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; investigation, replacement, modification, or support of the anatomy of a physiological process; Supporting or sustaining life; Control of conception; Disinfection of medical devices; and providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body and (b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.
Classification of Medical Device
||Those needing the lowest level of regulation because of low risk to the patient except sterile products. They are subject to the General Controls requirements. Declaration of conformity is accepted from the legal manufacturer.
||Invasive in their interaction with the human body, but the methods of invasion are limited to natural body orifices. The category may also include therapeutic devices used in diagnosis or in wound management
||Low - Moderate
||They are either partially or totally implantable within the human body, and may modify the biological or chemical composition of body fluids.
||High - Moderate
||Require design/clinical trial reviews, product certification and an assessed quality system involving clinical trials. These devices affect the functioning of vital organs and/or life-support systems. Devices are usually invasive, life-sustaining, life-supporting, or is used "in preventing impairment of human health or if the device presents a potential unreasonable risk of illness or injury".
Validity and Postmarket
|Post Market Surveillance
||Medical Device Vigilance System must be implemented and maintained: Maintain distribution procedures record. Maintain adverse incident reporting procedures and records. Have procedures to promptly and effectively execute investigations and recalls of defective medical devices.
||-Licenses can be acquired in nine months
-Some devices may apply for an intermediate importation approval in only two months.
Documents may be submitted in English
* Recognized countries: Europe, the US, Australia, Canada or Japan