The market of previously owned medical devices in Mexico works in different business models and therefore, arises questions about its regulatory requirements. For instance, public hospitals in Mexico are not allowed to buy previously owned medical equipment, but they can accept them by donation. It is also well known that used, refurbished or remanufactured medical devices are an attractive option for small clinics in the country. Then, it is not clear if through a donation the product safety is guaranteed or if small clinics import the products based on a sanitary registration.
Fortunately, the regulation of these products is well stablished in Mexico. Hence, in this text we focus on describing the restrictions and regulations involved in the purchase and import of such devices. We will consider the medical imaging equipment case, since it is the most common in this market. Nevertheless, the regulations to be discussed are applicable for all type of medical devices.
It is worth to mention the following definitions for a better understanding:
- Used: medical device that has being used for its purpose for a certain period of time, maintaining its original specifications.
- Refurbished: a product that has been restored to the specifications of the original manufacturer.
- Remanufactured: medical device that was processed, conditioned, repackaged, restored, or repaired.
- Previously owned: medical device that is used, refurbished or in a remanufactured condition.
Medical imaging equipment is a type of medical device with the following characteristics:
- Based on specific technologies such as MRI, NMR, PET, EBC and X-ray.
- Are expensive.
- Need special qualified personnel for its installation and operation.
- Require maintenance, service, and are susceptible to be repaired.
Because of the above-mentioned attributes, brand new medical equipment represents a high investment with long term returns for private hospitals with limited budget. Thus, preowned medical equipment has arisen as a cheap alternative to offer affordable medical services. This is not illegal and is not considered as a bad practice, in the meantime the quality, safety, and efficacy is maintained along with a strong post marketing surveillance system.
Even when there are not official numbers, some reports indicate the existence of a solid and growing market for previously owned medical devices. The offer of this kind of devices is often treated by companies as ecologic alternatives, that is the case of Siemens Healthineers and its Ecoline division.
Regulations and restrictions
(The case of Mexico)
Any hospital interested on bringing a previously owned medical device to Mexico must request an import permit directly to COFEPRIS. The importer must submit to COFEPRIS an invoice proving the medical equipment is not new and a document with a statement indicating that the device is working properly.
This type of import permit is requested for a small number of pieces, and the device cannot be sold to a third party.
Another common practice to bring medical equipment to the country is to declare it as spare parts or accessories. Because such products are not declared as medical devices, customs agents do not request import permits for release. This is a bad practice if the product is a medical device by itself because it needs a sanitary authorization.
In conclusion, import permits are the regulatory way to import a used, refurbished, used or preowned medical device into Mexico. Any other strategy is considered a bad practice and must be avoided. Otherwise, the safety and efficacy of the products cannot be guaranteed in the country.
If you are planning to import previously owned medical devices, please contact us at email@example.com for more details.