One of the requirements to register a medical device in Mexico is to have a warehouse to store the product. Although there are no rules regarding the exact size of the warehouse, whether it is a small space with a few square meters or a large depot, there is a defined list of requirements that must be implemented by the establishment. This applies both to the Sanitary Registration Holder and to the distributors listed in the registration.
To legally operate a warehouse in Mexico, COFEPRIS requires submitting a Warehouse Notice, which informs the health authorities of the activities that will be carried out in the establishment.
A key point to consider is that the warehouse also requires a Quality Manager or Sanitary Responsible, who is the person responsible for all the activities developed in the establishment. The Quality Manager must be a health professional with experience in the field and must be declared in the Warehouse Notice.
In addition, warehouses for medical devices must be compliant with the requirements of the following standards:
- Official Mexican Norm NOM-241-SSA1: Good manufacturing practices for establishments dedicated to the medical device manufacture
- Supplement for establishments dedicated to the sale and supply of medicines and other health supplies
- Supplement for Medical Devices. Pharmacopoeia of the United Mexican States (latest edition)
- Official Mexican Norm NOM-240-SSA1-2012, Installation and operation of technovigilance
- Official Mexican Norm NOM-137-SSA1-2008 for labeling of medical devices
As stated in these documents, the warehouse must have a Quality Management System (QMS) with minimum requirements, such as:
o Scope for Good Documentation Practices (GDP)
o Scope of Good Storage and Distribution Practices (GSP)
o Being based on risk management principles
This QMS can be supported by international standards such as ISO 9001, ISO 31000, and ISO 13485 (current versions).
Finally, we recommend bearing in mind that the Quality System contains different elements developed according to the specific activities of the company. Some of these elements are:
- Quality manual
- Audits system
- Complaints management
- Handling of non-conforming product
- Deviation management and CAPA
- Product recall
- Control of changes
- Validation Master Plan
- Product monitoring and measurement
- Risk management
- Documentation control
- Product returns
FAQ: Medical Devices Warehouses in Mexico
- What are the basic requirements for a medical device warehouse in Mexico?
A medical device warehouse in Mexico must submit a Warehouse Notice, appoint a Quality Manager or Sanitary Responsible, and comply with applicable NOMs and quality system requirements such as GDP, GSP, and risk‑based processes.
- Is a warehouse required to register medical devices in Mexico?
Yes. COFEPRIS requires that all medical devices be stored in a properly compliant warehouse as part of the registration process, whether managed by the Registration Holder or an authorized distributor.
- What conditions must a medical device warehouse in Mexico maintain?
It must maintain controlled conditions aligned with good storage and distribution practices, documentation controls, monitoring, and a functional Quality Management System.
- Does the size of the warehouse matter for COFEPRIS?
No. There is no specific size requirement. The warehouse can be small or large as long as it complies with the regulations and supports its declared activities.
Conclusions
Based on the information provided, in Mexico all medical devices must be stored in a proper warehouse with controlled conditions. Such warehouse must submit a Warehouse Notice to COFEPRIS to legally operate.
In addition, the warehouse must implement a Quality Management System to ensure the quality, safety and effectiveness of the medical devices kept in the establishment until they are delivered to the final users.
If you need help to establish a medical device warehouse and meet all Mexican regulations, please contact us at [email protected]