National Regulatory System - (RS)
Legal provisions and regulations define requirements of transparency and dissemination of information to the public and relevant stakeholders.
Registration and Marketing Authorization - (MA)
Web site or other official publication
with SPC-like
information is
available and regularly updated.
Vigilance - (Vl)
Vigilance activities and relevant feedback are appropriately communicated to the public.
Market Surveillance and Control - (MC)
Documented and implemented procedures and mechanisms exist to prevent, detect and respond to substandard and or falsified medical products.
Licensing Establishments - (LI)
In order to protect public health, licensing activities are of outstanding importance and are considered fundamental, together with inspections activities, for guaranteeing the quality, safety and efficacy of medical products used within or exported out of the country.
Regulatory Inspection - (RI)
A database is established and regularly updated of all establishments which may be subject to inspection, along with their relevant regulatory decisions.
Laboratory Testing - (LT)
Laboratory testing activities are appropriately communicated to the public community.
Clinical Trials Oversight - (CT)
There are guidelines on the format and content of Clinical Trial applications.