DID YOU KNOW WHAT?  

If your company is subject to SECTOR SALUD regulations, you need to have this guidance information. 

National Health Regulation Authority:  

It is an agency of the Ministry of Health, composed of five directorates. Each one of them is in charge of, among other duties, the regulation and supervision process for the process of HEALTH RECORDS, Licensing, establishment qualification, authorization and registration of health professionals. Everything concerning the regulations that establish the procedures to evaluate, register, control, authorize the manufacture, importation, donation, exportation, commercialization, storage, distribution of cosmetic and hygienic products, food, medical devices and others related to health.  

Directions:

• Health Regulation 
• Food and Beverage Regulation
• Pharmacy 
• Medical Devices 
• Quality Control Laboratory

Sanitary registrations are formalized, managed and processed before this institution, which is necessary and required for different types of products, the most common being: medical devices, natural products derived from plants, animals or minerals, which have specific therapeutic indications; food supplements, processed, unprocessed and semi-processed foods; processed beverages, alcoholic beverages, pharmaceutical, cosmetic and hygienic products; etc.

Regulates the advertising of health-related products and services.

It issues authorizations and registers professionals and licenses establishments. 

Each sanitary registration has different technical procedures contemplated in the provisions issued in this regard and other legal instruments on the matter. There are different regulations issued through technical standards that also apply to this registration process.

The following are not subject to Sanitary Registration: Food and beverages in their natural state, whether or not they are packaged for commercialization, such as grains, fruits, vegetables, meats and eggs, among others.

About MEDICATION REGISTRATIONS: 

The registration of drugs for human use is a process that involves a series of stages to evaluate the quality of drugs from a technical, pharmacological and legal point of view, which provides the regulatory authority with the basic criteria necessary to determine the quality of drugs and thus authorize, through a Health Registration certificate, the distribution and/or marketing of pharmaceutical products, whether domestic or imported.