In a previous article, we talked about the Good Manufacturing Practices (GMPs) certificates that can be used in Mexico. This certificate is broadly used in the Medical Device Industry, and it is a way to demonstrate that processes are followed to guarantee the quality of the product.
In this document, we will discuss about the Good Manufacturing Practices issued by COFEPRIS for medical devices made in Mexico. This is particularly interesting, for those International medical device companies looking to expand their manufacturing facilities to other countries.
In Mexico, the Good Manufacturing Practices certificate is applicable to the manufacture of medicines, medical devices or other health supplies manufactured and marketed in the country.
The Mexican regulations related to GMP’s are:
- The General Law of Health
- Regulations for Health Supplies
- Regulations from the General Law of Health regarding to Controls for Health-related Activities, Establishments, Products and Services
- NOM-241-SSA1-2021, Good Manufacturing Practices for the establishments dedicated to produce medical devices
- This standard defines all the regulatory conditions to be audited and considers both, documentary and infrastructure requirements for the manufacturing facility.
Any medical device manufacturer interested to establish a health supplies manufacturing site in Mexico, must satisfy the above-mentioned regulations before requesting a GMP certificate. It is worth mentioning, that this is not mandatory if the facility is located abroad the Mexican republic. That being the case (having a facility outside Mexico), it is still necessary to present a GMP certificate like ISO 13485, MDSAP, CE certificate, or the GMPs certificate released by the Ministry of Health in the country of origin.
Contract manufacturers are also subject of this GMP certificate. These facilities generally produce a medical device under the brand of the legal manufacturer. Such contractors are also obligated to request an audit to COFEPRIS for the GMP certificate from COFEPRIS if located in Mexico.
Then, in order to receive the GMPs certificate from COFEPRIS, the first step is to apply for a Sanitary Verification Visit (an audit). For such visit, it is necessary to comply with the following requirements:
- Official Format (COFEPRIS-05-016-C)
- Payment of fees
- General data of the establishment
- Medical device(s) to be audited
- Establishments involved in the manufacturing process
- Process carried out in each establishment
- Indication of use of the medical device(s) to be audited
- Person designated to attend the visit
On the other hand, the technical requirements are:
- Organizational charts
- Description of the production areas
- Flowchart of the manufacturing processes
- Summary of the Quality Management System
- Validation and qualification reports.
This process is mandatory for all manufacturers located in Mexico, but optional for foreign manufacturers. For instance, it could be useful when the manufacturer that will register and sell their products in Mexico, is not able to provide a GMP or ISO 13485 certificate.
In more recent developments, an announcement was made on July 7, 2023, regarding COFEPRIS’ criteria regarding MDSAP certificates and its viability as an alternative for GMP certificate. It states that, in order to harmonize with global regulatory standards, the MDSAP certificate will now officially be recognized as an equivalent to GMP for new registrations, renewals, and modifications of sanitary registries. This recognition applies to products manufactured both within and outside Mexican territory.
It is important to note that the validity and application of the contents of this announcement rely solely on COFEPRIS’ criteria. We will closely monitor any further developments related to this new announcement.