As mentioned in our Classification and Grouping Ultimate Guide, 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 surgical instruments following simple general rules. We also detail some particularities that can be found according to our everyday experience.
General characteristics of Surgical Instruments
Talking about surgical instruments can embrace a wide range of specialties. Nevertheless, in this article we will focus on those common supplies used in medical practice during surgery (e.g. forceps, scalpels, clamps, retractors, and scissors).
Manufacturers of these instruments generally manage catalogues with hundreds of models that vary in size and intended use. We have seen for years that a normal practice in the manufacturing cycle is to receive an unprocessed instrument (or the raw material) from one country and process it in another. This particular case, when the instruments are processed in different sites, is a key point to identify the real manufacturer –a relevant entity in regulatory terms.
Every point described so far has regulatory implications that we will explain in the following sections.
Classification according to the level of risk
Surgical instruments by their nature are classified as Class 1 medical devices in Costa Rica according to Rule 3; however, single-use surgical instruments are classified as Class 2 by the Ministry of Health.
Grouping for Sanitary Registration purposes in Costa Rica
The classification for Surgical Instruments is pretty straightforward. Yet, it is still necessary to consider a few points regarding the grouping criteria. Specifically, surgical instruments can be grouped in the same sanitary registration if they have:
- Same intended use.
- Same manufacturer.
- Same design and manufacturing process.
- Differences in shape, color or size.
As referred at the beginning of this article, the manufacturer is not necessarily an obvious entity to define. For instance, some countries consider surgical instruments as low risk devices and exempt them from extensive review. Therefore, they get approval in industrialized countries (e.g. USA , Europe) but not in their country of origin.
In Costa Rica, Class 1 devices are no longer registered per regulation N° 41387-S issued on November 26, 2018. Additionally, something important to highlight is that the regulatory requirements for products approved by the FDA in the USA are less in Costa Rica. This is part of the Ministry of Health recognition of international agencies.
Another challenge to consider is grouping thousands of products –a common scenario within the surgical instruments field. The best way to proceed in such cases is grouping the instruments based on their intended use. Nevertheless, we also understand that grouping scalpels in one registration, retractors in another and so on, ends up in a considerable number of registrations and therefore, in an economic investment to take in mind. Therefore, a riskier strategy if the number of projects is out of budget, is to comply with the criteria referred at the beginning of this section. In other words, as many similar characteristics the products share each other, the better the chances to group them.
As a side note, instruments for the orthopedic sector follow a standard presentation on which implants and instruments are sold in separate non-sterile trays. This makes the grouping of the instruments easier. You can check more details about it in this article.
Thanks for reading this article. If you have any question, feel free to contact us at [email protected] or check our guides.
