Combination products and regulatory approach in Mexico

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In general terms, combination products consist in a pharmaceutical product including chemical synthesis molecules, biologic or biotechnological API’s, that are contained in a medical device. Such products are already being regulated in the USA and EU. In Mexico, it can be confusing registering a product combining medicines and medical devices. In this article we will discuss about this interesting topic.


Definitions and examples


The definition of combination products is complex, but can be summarized as follows:


A product composed by any combination of a drug, biologic and/or medical device. It can be single products, separated, packed together or intended to be used together for the same purpose or therapeutic indication.


Typical examples of these kind of products are:


  1. Stent eluting a drug such as paclitaxel
  2. Hyaluronic acid with lidocaine prefilled in syringes
  3. IUD with drug such as levonorgestrel
  4. Condom with spermicide
  5. Insulin injection pen
  6. Metered dose inhaler


USA Regulations


The USA Food and Drug Administration (FDA), is a lead agency in the regulation of combination products. This term is included in 21 CFR 3.2 (e). In addition, several Guidance Documents have been released since 2004.

The most recent release is the document called Principles of Premarket Pathways for Combination Products Guidance for Industry and FDA Staff issued on January 2022.


UE Regulations


The European Medicines Agency (EMA) has been also considering combination products and recently has release his Guideline on quality documentation for medicinal products when used with a medical device EMA/CHMP/QWP/BWP/259165/2019.


This guidance became valid on January 2022 and is intended to be aligned and complementary to the Medical Devices Regulation (MDR).


The case of Mexico


Grouping combination products is not well defined in Mexico. Then, it may be confusing to define if the product need a Sanitary Registration as a Medicine, Medical Device or both separately.


Here we give some tips and hints to avoid drawbacks and delays in such cases:


  1. Identify the main therapeutic indication or intended use of your product.
  2. List all the components of your product.
  3. Confirm if the main intended use of your product is granted mainly by pharmacological, immunological, or metabolic pathways or not.
  4. Define if your product or any component can be classified as a medical device.
  5. Find out if you can fill all the general requirements to whether register your product as a medical device or as a medicine.


Based on this criteria you can identify other similar cases and compared them with your product. This process will also help your regulatory consulting team to better evaluate the case in Mexico.




Combination products are becoming more common, and some countries and regions are already considering them in their regulations. However, in Mexico its authorization may become complex because the lack of local regulations. If you need to get a Sanitary Registration for combination products in Mexico and have further doubts, please contact us at