Which are the products that do not need to be regulated at Anvisa?

Did you know that some products do not need to be regulated at Anvisa? In our consultancy, we come across many customers who have this question, and in this blog post, you will understand better about the regulation of products and which of them have another form of registration.

Product registration

Concerning the product registration, it is important to know that every company that manufactures, sells, or imports products related to health surveillance must be properly regulated by Anvisa following the legislation to be able to carry out the activities.

In addition to product registration, the company needs to be regularized so that product regulation can be carried out.

know more about how to regularize your company.

Classification of products

The classification of products is one of the factors that will determine the regulation of the product. As stated by Anvisa, the classification is made according to the type, that is, the product category and its degree of risk.

There are four product classifications, which are risk classes I, II, III, and IV. See below:

• Risk rating I: registered products
• Risk classification II: notified
• Risk classification III and IV: registered

Since the products of risk classes III and IV the factory needs the Certificate of Good Manufacturing Practices.

Products that do not need regulation at Anvisa

According to Anvisa’s rules, some products do not need to be regulated, going through a simpler approval process by the regulatory agency.

CATEGORY 1: PRODUCTS USED IN THE EVALUATION, PREPARATION, MANUFACTURING, OR PREPARATION

1. Dental amalgamator
2. Prostheses making machine
3. Equipment for the preparation of spectacle lenses
4. Fractionator, doser, or mixer of solutions or drugs
5. Barcode reader
6. Tablet making 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 glasses frames
9. Health product packaging sealer

CATEGORY 2: PRODUCTS TO SUPPORT GENERAL LABORATORY ACTIVITY

1. Knife sharpener for microtome
2. Solution shaker
3. Laboratory shaker, except blood and blood products
4. Distilled water
5. Platinum handle for microbiology
6. Water analyzer
7. Tablet and capsule dissolution analyzer
8. Particle size analyzer
9. Karl Fisher device, except 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 pyrogenic testing in guinea pigs
14. Apparatus for water treatment, except those indicated for water purification for use in hemodialysis, for portable use.
15. Laboratory heater
16. Plastic or glass article without laboratory reagent, except biological sample collectors or collection containers (IVD)
17. Autoclave, except for sterilization of medical products
18. Laboratory balance
19. Histological bath
20. Water bath, except for implants and blood bags.
21. Calorimeter, except for health diagnostics
22. Anaerobic chamber
23. Laminar flow hood, except for laboratory health use (eg, chapel for manipulating organs and tissues for transplantation).

23.1 Booth for the preparation of supplies, medicines, or chemotherapy

1. Centrifuge, except for use in a clinical laboratory (IVD)

24.1 Centrifuge, except for use in blood banks

1. Emergency shower and eyewash
2. Colorimeter, except for clinical diagnosis (IVD)
3. Conductivometer, except for health diagnostics
4. Colony or cell counter, except for clinical diagnosis (IVD)
5. Atomic particle counter, except for health use
6. Slide stainer for microscopy, except for use in the clinical laboratory (IVD)
7. Dye or solution for preparing samples or substances, except as indicated for clinical diagnosis (IVD).
8. Cryostat, except for clinical diagnosis (IVD)
9. Chromatograph, except for clinical diagnosis (IVD)
10. Stopwatch for measuring reaction time
11. Densitometer, except indicated for clinical diagnosis (IVD)
12. Digester
13. Sample thinner
14. Automatic dispenser (for filling bottles and tubes)
15. Paraffin wax dispenser/remover for histology
16. Device for opening or sealing articles
17. Sample management equipment
18. Personal protective equipment for exclusive use in laboratories.
19. Spectrophotometer, except for clinical diagnosis (IVD)
20. Spectrometer, except for clinical diagnosis (IVD)
21. Greenhouse, except for sterilization of medical products and products for beautification or aesthetics
22. Centrifugal vacuum evaporator
23. Crop fermenter
24. Filter for solutions
25. Muffle furnace
26. Flame photometer
27. Solution homogenizer, except for blood and blood products
28. Cassette and glass slide printer.
29. Incubator, unless indicated for clinical diagnosis (IVD)
30. Solution settling speed indicator
31. Physical, chemical, or biological indicator
32. Washer for laboratory articles, except medical product disinfecting washers.

56.1 Washer for laboratory articles, except microplate washers and washers for immunological assays (IVD)

1. Fluorescence reader, except for clinical diagnosis (IVD)
2. Skin asepsis handkerchief
3. Freeze dryer
4. Luximeter
5. O2 meter dissolved in samples
6. pH meter, except for clinical diagnosis (IVD)
7. Melting point meter
8. Microscope, except for medical or dental procedures
9. Microtome for histology, except for clinical diagnosis (IVD)
10.  Laboratory furniture
11.  Solid sample mill
12.  Bacterial growth monitor, except for clinical diagnosis (IVD)
13.  Automatic slide and coverslip assemblers
14. Razors for microtomes and cryostats
15. Osmometer, except for clinical diagnosis (IVD)
16. Automatic pipette
17. Manual pipette or micropipette, capillaries or microcuvettes (no reagents)
18. Heated/cooled plate for histology
19. Cotton holder
20. Briefcase holder
21. DNA processor, except indicated for clinical laboratory (IVD)
22. Histology tissue processor, except for use in the clinical laboratory (IVD)
23. Product for testing non-diagnostic application solutions
24. Radiometer, except for use in phototherapy devices
25. Container for disposal of organic waste (garbage)
26. Refractometer, except for clinical diagnosis (IVD)
27. Laboratory goods packaging sealer
28. Support for laboratory items
29. Timer
30. Titrator
31. Viscometer, except for clinical diagnosis (IVD)

CATEGORY 3: PRODUCTS USED FOR HOSPITAL SUPPORT OR INFRASTRUCTURE

1. Wheelchair cushions, except for ulcer prevention
2. Oilseed
3. Apparatus for environmental treatment or conditioning
   1. Air conditioners
   2. Air purifier
   3. Air sterilizer
   4. Air humidifier
4. Bib for dental use
5. Bucket
6. Trays / Boxes / Cases, including for sterilization (Labels to identify boxes / racks)
7. Barrier for separation of environments
   1. Screen
8. Vacuum pump
9. Boiler
10. Pen for surgical marking

CATEGORY 4: PRODUCTS FOR TEACHING OR MEDICAL TRAINING

1. Medical training manikin
2. Organ model for teaching
3. Physiological functions simulator for teaching

CATEGORY 5: PRODUCTS FOR THE PREVENTION OF COLLECTIVE HEALTH

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 PRACTICE

1. Gym bar
2. Ball
3. Wheelchair and bicycles for people with special needs for use in sports and competitions.
4. Stopwatch

4.1 Training Watch

1. Dart
2. Adhesive nasal dilator
3. Disc
4. Passive fitness equipment

CATEGORY 7: PERSONAL OR HOUSEHOLD PRODUCTS

1. Hygienic absorbent
2. Pliers and scissors to cut nails
3. Apparatus for environmental treatment or conditioning
   1. Air conditioners
   2. Air purifier
   3. Air sterilizer
   4. Air humidifier
4. Scales
5. Shaver
6. Cane or other non-orthopedic support
7. Piercing earrings
8. Pacifier
9. Menstrual collector
10. Dental brush

CATEGORY 8: PRODUCTS OF GENERAL USE USED AS PARTIES OR ACCESSORIES OF HEALTH PRODUCTS

1. General-purpose photo camera
2. General-purpose computer equipment
3. Common photographic film for general use
4. Fixer or developer of films
5. Image recorder, 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. Thermo-sensitive paper, including indicated for recording medical signs or images

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

CATEGORY 10: SOME PRODUCTS USED IN LABORATORIES

1. Laboratory glassware, material, and instruments for general 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 diagnostics (acid / alkaline solutions, alcohols, pH indicators) and other reagents that are not directly related 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, medication or food control, industrial analysis, among others)
4. Culture media in the form of dehydrated powders and supplements to enrich media and other unfinished products that require processing and controls performed by the user
5. Biological indicators
6. Reagents and reference materials specifically intended for quality assessment in proficiency tests or interlaboratory comparison
7. Reagents or reagent sets assembled in the service itself to be used exclusively at the same institution, following defined work protocols, and their commercialization or donation is prohibited
8. Laboratory reagents that are not intended for diagnosis in a human sample
9. Products intended exclusively for sports doping control tests, the result of which is not used for treatment or health
10. Products for exclusive use in research, including those imported and labeled as RUO – Research Use Only

Source: Anvisa

To see the complete list of unregulated products click here and check the Anvisa’s page.

Should you want to know more about this and other subjects, please read our blog or contact us and shed some light on your doubts with our specialists.