Quality Standards for Medical Devices


There has always been a need to know that healthcare products and services meet certain quality standards in medical devices as well as being adequate and useful for the patient.
In the past, everything was based on a pharmacopoeia, a word that comes from Latin and literally means drug preparation, which is a collection of official standards for active ingredients and drugs. It includes instructions for quality control tests to be performed on drugs and raw materials used in production.

It is a vital reference for individuals and organizations involved in the research, development and quality control of medicines, as its primary purpose is to ensure the good quality of medicines.
Most countries have an official pharmacopoeia and all manufacturers of drugs or substances for pharmaceutical use must comply with its quality and safety standards.
In Europe, the European Pharmacopoeia provides the legal and scientific basis for quality control during the development, production and marketing of medicines in the European member states.

Throughout history, European nations have written and maintained their own local or national pharmacopoeias, but after World War II, the trend was born to create international pharmacopoeias in collaboration with some clinical research groups from different countries to create common works, although they keep the main works like other countries such as the USP of the United States.


Current pharmacopoeias are aimed at compliance with standards and quality. The precepts of modern pharmacopoeias now include the following points:

  • Quality standards for active ingredients
  • Formulation standards
  • Standards for drug manufacturing
  • Finished product monographs
  • Standard terminology


In addition to all the issues that we have seen that are taken into account for the manufacture, control and marketing of medicines. We can also say that there are currently many ways to monitor compliance with best practices in the manufacture of medicines, such as the regulatory bodies of each country, in addition to all the support issues that exist in the health sector.

In Mexico, in addition to having an updated pharmacopoeia and international reference as the local ones of all the participating countries, there is COFEPRIS that determines the free access or free sale medicines, which are defined as those medicines whose sale does not require a medical prescription and are mainly used by consumers under their own initiative and responsibility.


In our country there are 6 classifications of how a medicine is sold or dispensed. In Article 226 of Mexico’s General Health Law, Sections V and VI refer to drugs that are freely available for sale and dispensed to the public; in contrast, Sections I to IV require a prescription. Section V refers to over-the-counter drugs authorized for sale exclusively in pharmacies.

In the case of drugs in section VI, they may be purchased without a prescription and may be sold in establishments other than pharmacies, hence the medical advice or recommendation is centered on the labeling (label) of the product or its instructions. The same Law states that medicines or other health supplies may not be sold in semi-fixed stalls, mobile or ambulant modules.

In addition to all these options, many companies or organizations opt for international standards such as ISO standards, which within their requirements and those of the organizations can comply with many of the legal terms that these companies or organizations must comply with.

To learn more about the standards applicable to medical devices, we invite you to contact us, in QAlliance we are ready to provide you with the information you need, in addition to guide you to your certification in ISO standards.