Costa Rica Registration Holder
The Costa Rica Registration Holder (CRH) is the physical or legal entity who manages the sanitary registration of an EMB (Equipment or Biomedical Material) or Medical Device and who acts as the primary point of contact with the Ministry of Health (MoH). In addition, the holder is in charge of submitting any regulatory requirement to the authorities. In other words, the CRH plays a key role as your partner during the life cycle of the sanitary registration in Costa Rica.
Similarly, the Product Holder is another relevant party involved in this regulatory process. The Product Holder owns the EMB with a specific commercial name. In most cases the Product Holder is the legal manufacturer.
Article 3rd of the directive in Costa Rica No. 34482-S is well-detailed about the definitions of these entities and others who play a relevant role in the regulatory cycle. We have selected those that we consider important:
Manufacturer
Any physical or legal person, responsible for the design, manufacture, packaging and labeling of EMB with the intention of being marketed under its own name, whether these operations are carried out by that same person or by third parties on their behalf.
Some of its responsibilities are
- Assure that the designed products work for the declared purpose.
- In case of local manufacturers, maintain the Costa Rica Ministry of Health authorization with the valid operation permit.
- Get and maintain a certificate of good manufacturing practices.
- Develop and present a surveillance program.
- Declare, in the case of refurbished or used EMBs, that the device preserves its quality, safety, and efficacy.
It is worth mentioning that the Manufacturer is who in other countries is considered as the real manufacturer. On the other hand, the Product Holder is who is considered the legal manufacturer.
Importer
Besides the relationship that it has with the Product Holder (the entity who owns the commercial name of the product), this entity imports the products and generally distribute them in the country
- The importer must work through an operation permit and be mentioned in the sanitary registration in order to import the products to Costa Rica.
Distributor
Any physical or legal person, national or foreign, who in his own name or that of a third party, is regularly engaged in distributing or marketing the EMB. As expected, the importer is usually the importer, as well.
When a distributor is not able to perform an importation or is not mentioned in the sanitary registration, it is known as a sub-distributor.
The role of the CRH in the Technovigilance
Many other countries with a strong regulatory system, identifies the term of “Technovigilance” as Post-Marketing Surveillance. This term refers to a system implemented by both the Ministry of Health and the private companies to monitor the approved medical devices that are being distributed in the country.
In Costa Rica, the Regulation of the National System of Technovigilance is identified with the code No. 39342-S and it seeks to establish the guidelines to implement the surveillance program.
The Costa Rica Registration Holder is the legal entity responsible to oversee the correct implementation of the technovigilance. Nevertheless, an efficient communication and interaction between all parties involved in the Medical Device cycle is a key factor for a successful surveillance program.