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Class 1 low risk Medical Devices in Costa Rica

costa rica medical devices

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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:

  1. Sanitary pads
  2. Disposable diapers for urinary incontinence in adults
  3. Hospital bed linen
  4. Medical clothing
  5. Plates, glasses, cups, platter, pot, pitcher(container)
  6. Cutlery
  7. Tongue depressor
  8. Hygiene items for patients
  9. Towel
  10. Housework gloves
  11. Hospital furniture (chairs, night stand, manual hospital bed, hydraulic hospital bed, infant cot)
  12. Home use scale
  13. Massage whirlpool
  14. Common use lamp
  15. Manual or battery lice combs
  16. Medical waste bag
  17. Exercise machines except those manufactured for therapeutic medical use
  18. Bedpan
  19. Pad for knee, elbow, wrist, fingers, ankle
  20. Maternity girdle
  21. Aesthetic shapewear
  22. Elastic stockings with a pressure less than 18 mm of mercury.
  23. Manual toothbrush
  24. Dental floss
  25. Hot or cold-water bag, ice application device, disposable, reusable and chemical
  26. Space heaters
  27. Environment humidifier
  28. Cotton swabs
  29. 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)
  30. Controlled atmosphere container
  31. Culture medium for environmental monitoring
  32. Antimicrobial susceptibility testing
  33. Ear molds
  34. Anti-snoring devices
  35. Dental plaster
  36. Medical plaster saw
  37. Plaster and metal polisher
  38. Bracket cleaner
  39. X-ray frame
  40. X-ray film hanger
  41. Cephalometric tracing paper
  42. Brushes for material application
  43. Braces box
  44. Instrument organizer
  45. Material organizer
  46. Pumice stone for dental use
  47. Rubber cup
  48. Mixing plaster spatula
  49. Investment ring
  50. X-ray viewer
  51. X-ray table
  52. Snellen eye chart
  53. Eye and ear dropper
  54. Helmets
  55. X-ray film dryer
  56. Hand grip
  57. Magnifying glass
  58. Cervical pillow
  59. Patient shaver kit
  60. Orthopedic shoes
  61. Heel socks / orthopedic support socks
  62. Liquid medicine spoon


Other products that should not be registered:

  1. Home use Massagers
  2. Sex toys, with the exception of condoms, lubricating gels and internal creams
  3. 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 or check our guides.

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