As mentioned in our Device Classification and Grouping Ultimate Guide for Costa Rica, there are a series of rules to consider when classifying and grouping medical devices. The above-mentioned rules are fully explained in Decree 43902-S by the Ministry of Health.
In this article, we will focus on explaining strategies to classify and group orthopedic implants following simple general rules and some particularities that can be found in these types of devices according to our everyday experience.
General characteristics of Orthopedic Implants
Most orthopedic implants are sold with the surgical instruments necessary for their placement. These devices are packed in stainless steel boxes including non-sterile implants and instruments to be autoclaved. However, there are cases in which the instruments or implants are sterilized from origin by the manufacturer.
On the other hand, any company could have a single kit of surgical instruments to be used with several commercial brands of orthopedic implants. In Costa Rica, this situation has regulatory implications to be explained in the following sections.
Classification according to the level of risk
Orthopedic implants by their nature are classified as long-term implantable (invasive) medical devices and according to their level of risk are generally classified as Class 3 by Rule 1.
On the other hand, instruments used to place these implants are considered reusable surgical instruments and can be classified as Class 1. These instruments are generally intended for surgical purposes to cut, drill, close, scarify, scrape, clamp, retract, trim or other similar procedures, without being connected to any active medical device and that can be used again after all relevant procedures. In case these instruments are single use Class 2 by Rule 1 must be applied.
Grouping for Sanitary Registration purposes in Costa Rica
Regarding grouping, as mentioned in our Classification and Grouping Guide
certain concepts are worth knowing to properly group a medical device in Costa Rica. For orthopedic implants the following concept is key:
- EMB group: It comprises a collection of EMBs that are presented for commercialization together to be used in a specific procedure. Its components may differ from each other and can be made by different manufacturers.
Even though instruments to place the orthopedic implants are considered class 1, when they come with the orthopedic implant (as a complementary tool), the Ministry of Health could consider them as a part of it, so it is possible to group them in a single sanitary registration. This is applicable in the meantime the instruments are intended to be used with those implants.
In addition, in case there a different types of implants (different intended use, manufacturer and/or design and manufacturing process), such products must be registered in separate registrations. In other words, you can group implants in the meantime they share the same intended use, manufacturer, design and manufacturing process.
Thanks for reading this article, if you have any questions about this topic, feel free to contact us at [email protected] or check our guidelines.
