List of products exempt from ANVISA registration

The registration of products is a fundamental regulatory requirement to certify the safety, efficacy and quality of commercialized items. In Brazil, ANVISA (the National Health Surveillance Agency) is the body responsible for regulating, inspecting and analyzing registration processes for various segments, such as food, cosmetics, medicines and sanitizers. The main objective of this mechanism is to protect public health, since strict control of the origin, composition and manufacture of products makes it possible to identify and mitigate potential risks to the population. In addition, registration makes it possible to adopt corrective and preventive measures, ensuring that only items that meet the established technical and legal standards are made available on the market.

When a product does not need to be registered with ANVISA (National Health Surveillance Agency), it means that it is not subject to the formal process of evaluation and prior approval by the agency before being marketed. This is because the product in question is considered to be of low risk to health or already has specific regulations that dispense with the need for registration.

ANVISA classifies products into different categories, such as medicines, cosmetics, food, health products, sanitizers, among others. For each category, there are specific criteria that determine whether or not the product needs to be registered. Products that do not require registration are generally subject to less rigorous control, but still need to comply with the quality, safety and efficacy norms and standards established by the agency.

It is important to note that even without registration, the manufacturer or importer is responsible for the safety and quality of the product, and ANVISA can inspect and take action if there are irregularities.

According to the ANVISA website, we have the following list:

CATEGORY 1: PRODUCTS USED IN THE EVALUATION, ELABORATION, MANUFACTURE OR PREPARATION

1. Dental amalgamator
2. Equipment for making prostheses
3. Equipment for making spectacle lenses
4. Solution or medicine fractionator, doser or mixer
5. Barcode reader
6. Tablet manufacturing machine
7. Material for exclusive use in the laboratory for making prostheses that do not come into contact with the patient.
8. Meter for evaluating lenses (lensometer) or spectacle frames
9. Sealer for health product packaging

CATEGORY 2: PRODUCTS TO SUPPORT GENERAL LABORATORY ACTIVITIES

1. Microtome knife sharpener
2. Solution stirrer
3. Laboratory shaker, except for blood and blood derivatives
4. Distilled water
5. Platinum loop for microbiology
6. Water analyzer
7. Tablet and capsule dissolution analyzer
8. Particle size analyzer
9. Karl Fisher apparatus, except indicated for clinical diagnosis (IVD)
10. Apparatus for food analysis
11. Apparatus for determining the friability of samples
12. Apparatus for electrophoresis, except indicated for clinical diagnosis (IVD)
13. Apparatus for pyrogen testing in guinea pigs
14. Apparatus 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 items for the laboratory, except biological sample collectors or collection containers (IVD)
17. Autoclave, except for sterilizing medical devices
18. Laboratory scales
19. Histological bath
20. Water bath, except for implants and blood bags.
21. Calorimeter, except indicated for health diagnostics
22. Anaerobic chamber
23. Laminar flow hood, except indicated for laboratory use in health (e.g. hood for handling organs and tissues for transplantation)
24. Chapel or cabin for preparing inputs, medicines or chemotherapy drugs
25. Centrifuge, except for clinical laboratory use (IVD)
26. Centrifuge, except for use in blood banks
27. Emergency shower and eyewash
28. Colorimeter, except indicated for clinical diagnosis (IVD)
29. Conductivity meter, except indicated for health diagnostics
30. Colony or cell counter, except indicated for clinical diagnosis (IVD)
31. Atomic particle counter, except indicated for health use
32. Microscope slide stainer, except for clinical laboratory use (IVD)
33. Dye or solution for preparing samples or substances, except indicated for clinical diagnosis (IVD).
34. Cryostat, except indicated for clinical diagnosis (IVD)
35. Chromatograph, except indicated for clinical diagnosis (IVD)
36. Chronometer for measuring reaction times
37. Densitometer, except indicated for clinical diagnosis (IVD)
38. Digester
39. Sample diluter
40. Automatic dispenser (for filling vials and tubes)
41. Paraffin dispenser/remover for histology
42. Device for opening or sealing articles
43. Sample management equipment
44. Personal protective equipment for exclusive use in laboratories
45. Spectrophotometer, except indicated for clinical diagnosis (IVD)
46. Spectrometer, except indicated for clinical diagnosis (IVD)
47. Oven, except for sterilization of medical devices
48. Centrifugal vacuum evaporator
49. Culture fermenter
50. Solution filter
51. Muffle furnace
52. Flame photometer
53. Solution homogenizer, except for blood and blood derivatives
54. Cassette and glass slide printer.
55. Incubator, except indicated for clinical diagnosis (IVD)
56. Solution sedimentation rate indicator
57. Physical, chemical or biological indicator
58. Washer for laboratory articles, except disinfectant washers for medical products.
59. Washer for laboratory articles, except microplate washers and washers for immunological assays (IVD)
60. Fluorescence reader, except indicated for clinical diagnosis (IVD)
61. Wipes for skin asepsis
62. Freeze dryerLuxímetro
63. Dissolved O2 meter in samples
64. pH meter, except indicated for clinical diagnosis (IVD)
65. Melting point meter
66. Microscope, except indicated for medical or dental procedures
67. Histology microtome, except indicated for clinical diagnosis (IVD)
68. Laboratory furniture
69. Solid sample mill
70. Bacterial growth monitor, except indicated for clinical diagnosis (IVD)
71. Automatic slide and coverslip mountors
72. Razors for microtomes and cryostats
73. Osmometer, except indicated for clinical diagnosis (IVD)
74. Automatic pipette
75. Manual pipette or micropipette, capillaries or microcuvettes (without reagents)
76. Heated/cooled plate for histology
77. Cotton holder
78. Paper holder
79. DNA processor, except suitable for clinical laboratories (IVD)
80. Tissue processor for histology, except for use in clinical laboratories (IVD)
81. Product for testing solutions for non-diagnostic use
82. Radiometer, except for use in phototherapy devices
83. Recipiente para descarte de resíduos orgânicos (lixo)
84. Refractometer, except indicated for clinical diagnosis (IVD)
85. Sealer for packaging laboratory articles
86. Stand for laboratory articles
87. Timer
88. Titleulator
89. Viscometer, except indicated for clinical diagnosis (IVD)

CATEGORY 3: PRODUCTS USED FOR HOSPITAL SUPPORT OR INFRASTRUCTURE

1. Cushions for wheelchairs, except for ulcer prevention
2. Cushions
3. Apparatus for environmental treatment or conditioning
   1. Air conditioners
   2. Air purifiers
   3. Air sterilizer
   4. Air humidifier
4. Dental 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. Pen for surgical marking
12. Mattress, armchair and pillow covers
13. Equipment cover
14. Compressed air unit
15. Medical gas plant
16. Vacuum plant
17. Comadre / kidney tub / parrot / spittoon
18. Air compressor
19. O2 concentrator, except for personal use
20. Styrofoam cutter for making molds
21. Device for destroying and rendering unusable medical products / counters (needles, scalpels, etc.)
22. Device for opening ampoule vials
23. Device for opening medical products
24. Packaging for sterilizing medical products
25. Packaging for the transportation and storage of organs
26. Equipment for packaging or transporting products
    1. Emergency trolley (transporting medicines, equipment and instruments for medical procedures), except when it has an IV stand and/or a panel with electrical, hydraulic or gas connections for medical products.
27. Laundry equipment
28. Stairs for patients, except when indicated for therapy
29. Brush for cleaning products in general
30. Brush for surgical cleaning and asepsis without antimicrobials
31. Hospital waste sterilizer, except for use at the health procedure site
32. Stove for food preparation
33. Gel for absorbing organic waste
34. General-purpose refrigerator and freezer (except for storing vaccines, blood bags, tissues and organs)
35. Steam generator
36. Plaster for making dental models
37. Hamper (container for storing hospital linen) and hamper bag
38. Hospital waste incinerator
39. Physical, chemical or biological indicator
40. Seals, mats, holders, brushes for cleaning instruments
41. Tarpaulin/device/field for patient transfer
42. Table, chair or other support not intended to support a medical or dental procedure.
    1. Dental or surgical table.
    2. Waiting chairs
    3. Office/clinic furniture (tables, chairs, cupboards and other supports).
    4. Mayo table (support for surgical instruments)
    5. Bedside table
    6. Necropsy table
43. Negatoscope
44. Toilet paper / paper towels
45. Hospital sink
46. Product for the collection or destruction of sharps
47. Noise protection earplugs
48. Patient identification bracelets (including mother-child bracelets) and risk classification bracelets, plaques and other products for this purpose
49. Portable water purifiers, except those for purifying water for use in hemodialysis.Recipiente não fixado ao corpo para coleta de resíduos orgânicos
50. Container for collecting or packaging products in general
51. Temperature or humidity recorder (thermohydrograph)
52. Endodontic ruler for measuring files
53. Restrictors used to contain the patient
54. Bed linen, including disposable hospital linen
55. Bags for collecting hospital waste
56. Death bags/corpse bags
57. Orthopaedic heels
58. Medical air dryer
59. Medical product packaging sealer
60. Hospital communication system
61. Hospital signage system
62. Electronic dispensers used for packaging medicines and hospital materials

CATEGORY 4: PRODUCTS FOR DIDACTIC OR MEDICAL TRAINING

1. Mannequin for medical training
2. Organ model for teaching
3. Physiological function simulator for teaching

CATEGORY 5: PRODUCTS FOR COLLECTIVE HEALTH PREVENTION

1. Traps for disinfestation
2. Dedetection pump
3. Instrument for eliminating parasites and insects
4. Container for storing corpses

CATEGORY 6: FITNESS OR SPORTS PRODUCTS

1. Fitness bar
2. Ball
3. Wheelchairs and bicycles for people with special needs for use in sports and competitions
4. Stopwatch
5. Training clock
6. Javelin
7. Adhesive nasal dilator
8. Disc
9. Passive fitness equipment
   1. Exercise bike (except indicated for medical diagnosis)
   2. Dumbbells
   3. Bodybuilding stations
   4. Rowers
   5. Abs machine
   6. Treadmill (except indicated for medical diagnosis)
10. Massage table or chair
11. Equipment exclusively for gyms or home use (except muscle stimulators and tanning beds)
12. Podometer (step counter/distance traveled)
13. Non-orthopaedic body protector
14. Platform (except for physiotherapy)
15. Jumping pole

CATEGORY 7: PERSONAL OR HOUSEHOLD PRODUCTS

1. Sanitary towels
2. Nail clippers and scissors
3. Environmental treatment or conditioning device
   1. Air conditioners
   2. Air purifiers
   3. Air sterilizer
   4. Air humidifier
4. Scales, except bioimpedance scales intended for health therapy or diagnosis.
5. Shavers
6. Cane or other support for non-orthopaedic use
7. Piercing earrings
8. Pacifiers
9. Menstrual cup
10. Dental brush
11. Hairbrush
12. Skin cleansing sponge
13. Dental floss
14. Disposable razor, except indicated for health procedures
15. Lens for magnifying scales
16. Tongue cleaner
17. Gloves not for use in healthcare
18. Bottle and nipple
19. Blankets without therapeutic indication.
20. Gum massager
21. Muscle massagers (cushions, chairs, armchairs, mattresses, etc.) with no therapeutic indications
22. Teether for infants
23. Glasses for presbyopia
24. Toilet paper/paper towels
25. Floss threader
26. Piercing
27. Pipettes and glass bottles for collecting, storing and pasteurizing human milk
28. Product for cleaning spectacle lenses
29. Product for sexual stimulation
30. Erotic products with no indication for health use
31. External breast prosthesis and prosthesis support bra
32. Nipple shield
33. Water purifier
34. Sauna
35. Hair dryer and brush
36. Maternity top, sling
37. Earring piercing device

CATEGORY 8: GENERAL PURPOSE PRODUCTS USED AS PARTS OR ACCESSORIES OF HEALTH PRODUCTS

1. General purpose cameras
2. General purpose computer equipment
3. General-purpose photographic film
4. Film fixer or developer
5. Image recorders, except those indicated for recording medical signs or images
6. Printer, except those indicated for recording medical signs or images
7. Video monitor, except those indicated for displaying medical images
8. Lubricating oil
9. Thermosensitive paper, including those indicated for recording medical signals or images

CATEGORY 9: PARTS AND ACCESSORIES FOR PRODUCTS NOT CONSIDERED HEALTH PRODUCTS

CATEGORY 10: SOME PRODUCTS USED IN LABORATORIES

1. General laboratory glassware, equipment and instruments (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 diagnostics (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, drug or food control, industrial analysis, among others)
4. Culture media in the form of dehydrated powders and supplements for enriching media and other unfinished products that require processing and controls carried out by the user
5. Biological indicators
6. Reagents and reference materials intended specifically for quality assessment in proficiency or inter-laboratory comparison tests
7. Reagents or sets of reagents assembled in-house to be used exclusively in the same institution, following defined work protocols, and their sale or donation is prohibited
8. Laboratory reagents that are not intended for diagnosis on 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 research use only, including those imported and labeled RUO - Research Use Only
11. Gas generators and anaerobiosis indicators
12. Reagents marketed as inputs for the manufacture of in vitro diagnostic products and products in the intermediate production phase
13. Products intended exclusively for forensic medicine (forensics and police investigation).
14. Products used exclusively by technicians of the supplier of in vitro diagnostic instruments in cleaning and maintenance procedures and which are not sold or made available to the market, such as calibration plates, standards for calibrating a specific test, cleaning and maintenance solutions, etc.Estreptavidina
15. Plastic cassette for histology
16. Cell fixatives

Stone Okamont combines technical expertise, regulatory knowledge and a personalized approach to meet the specific needs of each client. By working with us, the chances of your non-registered products complying with ANVISA standards increase, reducing risks and avoiding penalties. In addition, we optimize processes, allowing clients to focus on business growth while the regulatory side is managed efficiently and safely.

Still in doubt as to whether or not your product needs to be registered? Contact Stone Okamont.