Obtaining registration to medicines and medical devices
Sanitary Authorization stated in medicines; just like medical gear, prosthetic and orthotic pieces, functional aid, diagnostic agents, dental supplies, surgery material, healing material and hygiene products. This registration is made by the COFEPRIS and it is based upon the General Health Law from Mexico.
- Drugs Registration
Medicines, including vaccines, represent preventive and quick measures; they are also an efficient health strategy that has been long proven. Medicaments are an essential tool used against diseases and their consequences; these substances have been one of the main features that have enhanced society health and life quality. There are several types of medicines: at ENTIMEM, your allopathic medicines registry is encouraged, for both the new or generic molecule composition (these medicines take part of IV, V & VI groups).
- Registration of Medical Devices
Medical devices encompass from curing material, dental supplies, medical gear, up to a transplant (functional aid); these devices are used to prevent, diagnose or substitute the functioning of a body part, and require a Sanitary Registration so that they can be manufactured, distributed commercialized or used Mexico. These registries are the authorization that the Federal Government grants once the petitioner has shown, with official evidence, that the product is safe, efficient and of quality. ENTIMEM will help you with the registration for medical devices type I, II & III.