Mexico's Social Insurance Institute (Instituto Mexico del Seguro Social, IMSS) requires medical device manufacturers to follow the requirements of good Good Manufacturing Practices (GMPs) when applying for medical device registration certificates. GMP is a set of international standards to ensure quality and safety in the manufacturing of medical devices, covering all aspects of production, inspection, packaging, storage and distribution. The following is an example of the GMP review process for the IMSS registration certificate in Mexico:
A description of the manufacturing process, including steps such as raw material procurement, production, assembly, testing, and packaging.
A list of equipment and tools, including the specifications and performance parameters of the equipment.
Samples of production records and quality control records.
Description of cleaning and maintenance procedures.
Personnel training records.
Documentation and resolution of adverse events and quality issues.
2.Application Submission:The manufacturer submits the medical device registration application and the relevant GMP documents to the IMSS. Applications typically include detailed manufacturing and quality control information, as well as technical specifications and performance data about the medical device.
3.Document Review:The submitted GMP documents will be reviewed by IMSS's review team to ensure that they comply with GMP requirements and regulations in Mexico. A review typically includes a check of the completeness, consistency, and accuracy of the document.
4.On-site review:If the preliminary documentation review passes, IMSS may schedule an on-site audit to verify that the manufacturer's actual manufacturing process meets GMP requirements. The on-site audit includes inspections of:
Cleanliness and sanitation of manufacturing facilities.
Maintenance and calibration of equipment.
Quality control of raw materials and finished products.
Monitoring and documentation of the manufacturing process.
Training and practice of employees.
Procedures for handling adverse events and quality issues.
5.Reports and Recommendations:The IMSS's review team will prepare a report based on the results of the document review and the on-site review and make recommendations. If a violation or non-compliance with GMP requirements is found, the manufacturer will be asked to take corrective action.
6.Corrective Actions:Manufacturers are required to take corrective action based on IMSS's recommendations to address the identified issues. This may include equipment repairs, staff training, document revisions, and more.
7.Final Approval:IMSS will finalize the approval of the medical device registration certificate after satisfactory with the corrective actions taken by the manufacturer. The registration certificate will include requirements for GMP compliance, which manufacturers will need to comply with on an ongoing basis.
It is important to note that GMP review is an important part of ensuring the quality and safety of medical devices, and manufacturers need to fully understand and comply with GMP requirements to ensure the compliance of medical devices. Cooperation with IMSS and timely corrective action is key to ensuring the approval of the registration certificate.