Products not regulated as medical devices.
Published on 12/03/2020 3:34 pm Updated on 2/28/2023 5:58 pm
Updated on 05/10/2022
- CATEGORY 1: PRODUCTS USED IN EVALUATION, PREPARATION, MANUFACTURING OR PREPARATION
1. Dental amalgamator
2. Equipment for making prostheses
3. Equipment for making glasses lenses
4. Fractionator , doser or mixer of solutions or medicines
5. Barcode reader
6. Tablet Making Machine
7. Material for exclusive use in laboratories for making prostheses that do not come into contact with the patient.
8. Meter for evaluating lenses ( lensometer ) or eyeglass frames
9. Health product packaging sealer
- CATEGORY 2: PRODUCTS TO SUPPORT GENERAL LABORATORY ACTIVITY
1. Microtome Knife Sharpener
2. Solution shaker
3. Laboratory shaker, except blood and its derivatives
4. Distilled water
5. Microbiology Platinum Handle
6. Water Analyzer
7. Tablet and Capsule Dissolution Analyzer
8. Particle Size Analyzer
9. Karl Fisher apparatus, except indicated for clinical diagnosis (IVD)
10. Food analysis device
11. Apparatus for determining the friability of samples
12. Electrophoresis device, except indicated for clinical diagnosis (IVD)
13. Apparatus for pyrogenic testing on guinea pigs
14. Device for water treatment, except those indicated for purifying water for use in hemodialysis, for portable use.
15. Laboratory heater
16. Non-reagent plastic or glass laboratory article, except biological sample collectors or collection containers (IVD)
17. Autoclave, except for sterilization of medical devices
18. Laboratory scale
19. Histological bath
20. Water bath, except for implants and blood bags.
21. Calorimeter, except indicated for health diagnosis
22. Anaerobic chamber
23. Laminar flow hood, except indicated for laboratory use in healthcare ( ex : hood for handling organs and tissues for transplantation)
The. Chapel or cabin for preparing supplies, medicines or chemotherapy
24. Centrifuge, except indicated for use in a clinical laboratory (IVD)
The. Centrifuge, except indicated for use in blood banks
25. Emergency shower and eyewash
26. Colorimeter , except indicated for clinical diagnosis (IVD)
27. Conductivity meter , except indicated for health diagnosis
28. Colony or cell counter, except indicated for clinical diagnosis (IVD)
29. Atomic particle counter, except indicated for healthcare use
30. Microscopy slide stainer , except indicated for clinical laboratory use (IVD)
31. Dye or solution for preparing samples or substances, except indicated for clinical diagnosis (IVD).
32. Cryostat, except indicated for clinical diagnosis (IVD)
33. Chromatograph, except indicated for clinical diagnosis (IVD)
34. Stopwatch for measuring reaction times
35. Densitometer , except indicated for clinical diagnosis (IVD)
36. Digester
37. Sample Diluter
38. Automatic Dispenser (for filling bottles and tubes)
39. Histology Paraffin Dispenser/Remover
40. Device for opening or sealing articles
41. Sample Management Equipment
42. Personal protective equipment for exclusive use in laboratories
43. Spectrophotometer, except indicated for clinical diagnosis (IVD)
44. Spectrometer, except indicated for clinical diagnosis (IVD)
45. Greenhouse, except for sterilization of medical devices
46. Vacuum Centrifugal Evaporator
47. Crop fermenter
48. Filter for solutions
49. Muffle furnace
50. Flame photometer
51. Solution homogenizer, except for blood and its derivatives
52. Cassette and glass slide printer.
53. Incubator, except indicated for clinical diagnosis (IVD)
54. Solution sedimentation speed indicator
55. Physical, chemical or biological indicator
56. Washer for laboratory items, except for disinfecting washers for medical products.
The. Washer for laboratory items, except microplate washers and immunoassay washers (IVD)
57. Fluorescence reader, except indicated for clinical diagnosis (IVD)
58. Skin asepsis tissue
59. Freeze dryer
60. Luxmeter
61. Dissolved O2 meter in samples
62. pH meter, except indicated for clinical diagnosis (IVD)
63. Melting point meter
64. Microscope, except indicated for medical or dental procedures
65. Microtome for histology, except indicated for clinical diagnosis (IVD)
66. Laboratory furniture
67. Solid sample mill
68. Bacterial growth monitor, except indicated for clinical diagnosis (IVD)
69. Automatic slide and coverslip assemblers
70. Knives for microtomes and cryostats
71. Osmometer , except indicated for clinical diagnosis (IVD)
72. Automatic pipette
73. Manual pipette or micropipette, capillaries or microcuvettes (without reagents)
74. Heated/cooled plate for histology
75. Cotton holder
76. Paper holder
77. DNA processor, except indicated for clinical laboratory (IVD)
78. Tissue processor for histology, except indicated for clinical laboratory use (IVD)
79. Product for testing non-diagnostic application solutions
80. Radiometer, except for use in phototherapy devices
81. Container for disposal of organic waste (garbage)
82. Refractometer, except indicated for clinical diagnosis (IVD)
83. Laboratory item packaging sealer
84. Laboratory article support
85. Timer
86. Titulator
87. Viscometer, except indicated for clinical diagnosis (IVD)
- CATEGORY 3: PRODUCTS USED FOR HOSPITAL SUPPORT OR INFRASTRUCTURE
1. Wheelchair cushions, except for ulcer prevention
2. Almotolia
3. Apparatus for environmental treatment or conditioning
The. Air conditioners
B. Air Purifier
w. Air Sterilizer
d. Air humidifier
4. Dental use bib
5. Bucket
6. Trays / Boxes / Cases, including for sterilization (Labels for identifying boxes/racks)
7. Barrier for separating environments
8. Screen
9. Vacuum pump
10. Boiler
11. Surgical marking pen
12. Cover for mattresses, armchairs and pillows
13. Equipment Cover
14. Compressed air plant
15. Medical gas plant
16. Central vacuum
17. Bedpan/ rim vat/ parrot/ spittoon
18. Air compressor
19. O2 concentrator, except for personal use
20. Styrofoam cutter for making molds
21. Device that destroys and disables medical/counter products (needles, scalpels, among others)
22. Device for opening an ampoule bottle
23. Device for opening medical products
24. Packaging for sterilization of medical products
25. Packaging for transport and storage of organs
26. Equipment for packaging or transporting products
The. Emergency car (transport of medicines, equipment and instruments for medical procedures), except when it has a panel with electrical, hydraulic or gas connections for medical products.
27. Laundry Equipment
28. Staircase for patients, except indicated for therapy
29. Brush for cleaning products in general
30. Surgical cleaning and asepsis brush without antimicrobial
31. Hospital waste sterilizer, except for use at the healthcare procedure site
32. Food preparation stove
33. Gel for absorbing organic residues
34. Refrigerator and Freezer for general use (except for storing vaccines, blood bags, tissues and organs)
35. Steam generator
36. Plaster for making a dental model
37. Hamper (container for storing hospital clothes) and hamper bag
38. Medical waste incinerator
39. Physical, chemical or biological indicator
40. Seals, mats, supports, brushes for cleaning instruments
41. Tarpaulin/device/field for patient transfer
42. Table, chair or other support not indicated for supporting a medical or dental procedure.
The. Dental or surgical stool.
B. Waiting chairs
w. Office/clinic furniture (tables, chairs, cabinets and other supports).
d. Mayo table (surgical instrument support)
It is. Bedside table
f. Necropsy table
43. Negatoscope
44. Toilet paper/paper towel
45. Hospital sink
46. Product for collecting or disposing of sharp materials
47. Noise ear protector
48. Patient identification bracelets (including mother-child bracelets) and risk classification bracelets, plaques and other products for this purpose
49. Water purifier, except those indicated for water purification for use in hemodialysis, for portable use.
50. Container not attached to the body for collecting organic waste
51. Container for collecting or packaging products in general
52. Environmental temperature or humidity recorder ( thermohydrograph )
53. Endodontic ruler for measuring files
54. Restrictors used to restrain the patient
55. Bed linen, including disposable hospital linen
56. Bag for collecting hospital waste
57. Death bags/body bags
58. Orthopedic heels
59. Medical Air Dryer
60. Medical product packaging sealer
61. Hospital communication system
62. Hospital signage system
63. Electronic Dispenser used for packaging medicines and hospital materials
- CATEGORY 4: PRODUCTS FOR TEACHING OR MEDICAL TRAINING
1. Medical Training Mannequin
2. Organ Model for teaching
3. Physiological function simulator for teaching
- CATEGORY 5: PRODUCTS FOR COLLECTIVE HEALTH PREVENTION
1. Disinfestation trap
2. Pest control pump
3. Instrument for eliminating parasites and insects
4. Container for storing corpses
- CATEGORY 6: PRODUCTS FOR PHYSICAL CONDITIONING OR SPORTS
1. Gymnastics bar
2. Ball
3. Wheelchairs and bicycles for people with special needs for use in sports and competitions
4. Stopwatch
5. Training watch
6. Dart
7. Adhesive nasal dilator
8. Disco
9. Passive fitness equipment
The. Exercise bike (except indicated for medical diagnosis)
B. Dumbbells
w. Weight Stations
d. Rowers
It is. Abdominal machine
f. Treadmill (except for medical diagnosis)
10. Massage table or chair
11. Exclusive equipment for gyms or home use. (Except electrical muscle stimulators and tanning beds)
12. Pedometer (step counter/distance covered)
13. Non-orthopedic body parts protector
14. Table (except for physiotherapy)
15. Pole jumping
- CATEGORY 7: PRODUCTS FOR PERSONAL OR HOUSEHOLD USE
1. Sanitary napkin
2. Nail cutting pliers and scissors
3. Apparatus for environmental treatment or conditioning
The. Air conditioners
B. Air Purifier
w. Air Sterilizer
d. Air humidifier
4. Scales
5. Shaver
6. Cane or other support for non-orthopedic use
7. Piercing Earrings
8. Pacifier
9. Menstrual collector
10. Dental brush
11. Hair brush
12. Skin cleansing sponge
13. Floss
14. Disposable blade, except indicated for healthcare procedures
15. Lens to enlarge scales
16. Tongue cleaner
17. Gloves not indicated for health use
18. Bottle and nipple
19. Blankets and blankets without therapeutic indication.
20. Gum massager
21. Muscle massager (pillows, chairs, armchairs, mattresses, etc. ) without therapeutic indications
22. Teether for babies
23. Glasses for presbyopia
24. Toilet paper/paper towel
25. Floss threader
26. Piercing
27. Pipettes and glass bottles for collecting, storing and pasteurizing human milk
28. Product intended for cleaning eyeglass lenses
29. Product for sexual stimulation
30. Erotic products with no indication for health use
31. External breast prosthesis and bra to support the prosthesis
32. Nipple shield
33. Water purifier
34. Sauna
35. Hairdryer and brush
36. Motherly top, Sling
- CATEGORY 8: GENERAL PURPOSE PRODUCTS USED AS PARTS OR ACCESSORIES OF HEALTHCARE PRODUCTS
1. General purpose camera
2. General purpose computer equipment
3. Common general purpose photographic film
4. Film fixer or developer
5. Image recorder, except those indicated for recording medical signals or images
6. Printer, except those indicated for recording medical signals or images
7. Video monitor, except those indicated for displaying medical images
8. Lubricating oil
9. Thermosensitive paper , including suitable for recording medical signals or images
- CATEGORY 9: PARTS AND ACCESSORIES FOR PRODUCTS NOT CONSIDERED HEALTHCARE PRODUCTS
- CATEGORY 10: SOME PRODUCTS USED IN LABORATORIES
1. Glassware, material and instruments for general laboratory use (pipettes, tips, beakers, test tubes, coverslips, slides, cell counting chambers, petri dishes , etc. )
2. Isolated chemical reagents that do not have a specific purpose for in vitro diagnosis (acid/alkaline solutions, alcohols, pH indicators) and other reagents that are not directly related to or make up an in vitro diagnostic kit
3. Culture media and products not intended for human diagnosis (scientific research, veterinary use, water control, environmental control, medicine or food control, industrial analysis, among others)
4. Culture media in the form of dehydrated powders and supplements for enrichment of media and other unfinished products that require processing and controls carried out by the user
5. Biological indicators
6. Reagents and reference materials specifically intended for quality assessment in proficiency or interlaboratory comparison tests
7. Reagents or sets of reagents assembled in the service to be used exclusively in the same institution, following defined work protocols, with their sale or donation being prohibited
8. Laboratory reagents that are not intended for diagnosis in human samples
9. Products intended exclusively for sports doping control tests, the results of which are not used for treatment or health purposes
10. Products for exclusive use in research, including those imported and labeled as RUO – Research Use Only
11. Gas generators and anaerobic indicators
12. Reagents sold as inputs for the manufacture of in vitro diagnostic products and products in the intermediate phase of production
13. Products intended exclusively for legal medicine (police expertise and investigation).
14. Products used exclusively by technicians from the supplier of instruments for in vitro diagnostics in cleaning and maintenance procedures and which are not sold or made available to the market, such as calibration plates, standard for calibration of a specific test, cleaning and maintenance solutions , etc.
15. Streptavidin
16. Plastic cassette for histology
17. Cellular fixators
Source :ANVISA (PT)
