One of the requirements to register a medical device in Mexico, is to have a warehouse to store the product. It is true that there are not rules about the extension of the warehouse, but either it is a regular place with few square meters or a big depot, there is a list of requirements that must be implemented by the establishment. It is worth mentioning, that this is applicable for both the Sanitary Registration Holder and the distributors listed in the registration.
Then, in order to have a warehouse, COFEPRIS will require to get a Warehouse Notice, a notification submitted to the health authorities informing the activities that will be developed 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 is also declared in the Warehouse Notice.
In addition, warehouses of medical devices must be compliant with the requirements of the following standards:
- Official Mexican Norm NOM-241-SSA1-2021: 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. Fourth edition. Pharmacopoeia of the United Mexican States
- 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 based on compliance with international standards such as ISO 9001, ISO 31000 and ISO 13485 current version.
Finally, we recommend bearing in mind that the Quality System contains different elements that are developed in accordance to the specific activities of the company. Here are some of these elements:
- 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
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 contact@veraqueconsulting.com
