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 the decree 34482-S by the Ministry of Health of Costa Rica (MoH).
In this article, we will enlist the medical devices that are found in the Annex 1of the decree 34482-S and are considered as class 1 medical devices. We also discuss about some particularities that can be found according to our everyday experience.
Class 1 Medical Devices
As referred in our Regulatory Affairs Guideline, Class 1 medical devices in Costa Rica are exempt of registration. This is because they are considered as low risk, based on article 7 of the decree 34482-S. Such products are enlisted by the Ministry of Health as follows:
- Sanitary pads
- Disposable diapers for urinary incontinence in adults
- Hospital bed linen
- Medical clothing
- Plates, glasses, cups, platter, pot, pitcher(container)
- Cutlery
- Tongue depressor
- Hygiene items for patients
- Towel
- Housework gloves
- Hospital furniture (chairs, night stand, manual hospital bed, hydraulic hospital bed, infant cot)
- Home use scale
- Massage whirlpool
- Common use lamp
- Manual or battery lice combs
- Medical waste bag
- Exercise machines except those manufactured for therapeutic medical use
- Bedpan
- Pad for knee, elbow, wrist, fingers, ankle
- Maternity girdle
- Aesthetic shapewear
- Elastic stockings with a pressure less than 18 mm of mercury.
- Manual toothbrush
- Dental floss
- Hot or cold-water bag, ice application device, disposable, reusable and chemical
- Space heaters
- Environment humidifier
- Cotton swabs
- General chemistry laboratory equipment (graduated cylinder, Erlenmeyer, beaker, non-graduate pipettes, racks, filter paper, glassware in general, except for test tubes used to take blood samples)
- Controlled atmosphere container
- Culture medium for environmental monitoring
- Antimicrobial susceptibility testing
- Ear molds
- Anti-snoring devices
- Dental plaster
- Medical plaster saw
- Plaster and metal polisher
- Bracket cleaner
- X-ray frame
- X-ray film hanger
- Cephalometric tracing paper
- Brushes for material application
- Braces box
- Instrument organizer
- Material organizer
- Pumice stone for dental use
- Rubber cup
- Mixing plaster spatula
- Investment ring
- X-ray viewer
- X-ray table
- Snellen eye chart
- Eye and ear dropper
- Helmets
- X-ray film dryer
- Hand grip
- Magnifying glass
- Cervical pillow
- Patient shaver kit
- Orthopedic shoes
- Heel socks / orthopedic support socks
- Liquid medicine spoon
Other products that should not be registered:
- Home use Massagers
- Sex toys, with the exception of condoms, lubricating gels and internal creams
- Exercise machines
Given the large amount of medical devices in the industry, it is possible that your medical device is not included in this list, although you have identified it as Class 1. In such cases, we recommend to directly approach to the Ministry of Health in Costa Rica, looking forward for their confirmation. When received, such communication would be accepted for importation, tenders and commercialization purposes.
Thanks for reading this article, if you have any question about this topic, feel free to contact us at contact@veraqueconsulting.com or check our guides.
