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Services

Sanitary Registration

In Costa Rica, for the commercialization of medical devices, food products and cosmetics products, a sanitary registry is required. At SOLUMARK® we are specialists in the field and we can support you, accompany you and carry out the registration process in an orderly, economical and efficient manner.

Our services includes:

  1. Goverment Health Registrations
    • Medical Equipment Registrations
    • Cosmetics products Registrations
    • Food products Registration
  2. Trademark Registration

The service includes: inscriptions, renewals, changes post registration and more.

REGISTRATION PROCESS IN COSTA RICA:

How to make a health registrations in Costa Rica

In Costa Rica a health registry has four figures:

Local Legal Representative/ Registration Holder (Local company or Costa Rican person)

International Legal Representative/ Owner Operator (The company authorized by the manufacturer to sell the product, when the company doesn’t have a reseller, the manufacturer is the Legal Representative.

Manufacturer 

Distributors (companies in Costa Rica authorized by the International Legal Representative, they must be authorized by the Registry Holder)

If you have no local office in Costa Rica, you must designate a Costa Rica Registration Holder to interact with the Ministry of Health and manage the approval process on your behalf. This is an essential step in registering your medical device for sale in Costa Rica

Contact us!

Medical Device Registration

Medical devices are classified as Class 1, 2, 3, 4 in Costa Rica. The classification depends of the risk of the product, devices class 1 (low risk) don’t require a medical registration.

The most important requirement for the registration is the Free Sale Certificated issued by the Ministry of Health of the origin country, it must include all the codes or models of the devices to register, this document must be apostilled.

Also we will need the user manual or IFU and general catalog of the product to register, for class 3 and 4 we will need more information. If you are interested you can contact us at any time.

Medical Devices Representation service:

SOLUMARK® provides this service acting as a Registration Holder for companies that do not have direct operation in Costa Rica and wish to maintain control and autonomy of all the registrations.  Our service as Registration Holder is responsible for submitting all your medical device registration processes to the Ministry of Health and controlling your device registration once they are approved.

Our service includes:

  • Coordinate and summit necessary registration documents to the Ministry of Health of Costa Rica
  • Manage all changes, modifications, renewals, change distributors, or cancellations to your registration certificate

We have more than 12 years of experience and we work professionally and confidentially with each client.

We are neutral, we are not distributors of medical devices in Costa Rica, we are 100% independent and client focused.

Cosmetics Product Registration

A cosmetic product is any substance or preparation intended to be brought into contact with the various superficial parts of the human body (epidermis, hair and capillary systems, nails, lips and external genital organs) or with the teeth and oral mucosa, with the exclusive or main purpose of cleaning, perfuming, modifying their appearance and correcting body odors and/or protect them or keep them in good condition.

There is a list of cosmetic products that can be registered immediately you can ask us for more information about it.

The requirements to register a cosmetic products are:

  1. ISO 22716 or Good Manufacturing Practices of the manufacturer. Apostilled
  2. Power of Representation to the company in Costa Rica. Apostilled
  3. Quali-Quantitative formula
  4. Label of the product
  5. COA of the finished product

For more information contact us!

Food Sanitary Registration

The requirements to register food at the Ministry of Health in Costa Rica depends of the activity, if the company import of manufacture them here.

For importation:

1. Permiso de funcionamiento de Salud (PFS), its the authorization from a local office of the Ministry of Health that declarates that you have a warehouse in Costa Rica.
2. Label of the product.
3. Free Sale Certificate of the manufacture. Apostilled.

Manufacturing in Costa Rica:

1. Permiso de funcionamiento de Salud (PFS), its the authorization from a local office of the Ministry of Health that declarates that you manufacturer in Costa Rica.
2. Label of the product.

Contact us for more information!

Training

In the business world information becomes obsolete in a short time. Continuous training is part of the differentiation and focused approach towards the client. We offer trainings and training sessions inside and outside of your company and virtual mode, according to the needs of the business.

  1. Medical Device registration training
  2. Sales Workshops
  3. Customer Service Workshops
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