Among medical products, the orthopedic category refers to a broad range of devices and equipment designed to assist in the prevention, diagnosis, treatment, and rehabilitation of conditions related to the musculoskeletal system. These products are developed to support mobility, alleviate pain, correct deformities, and enhance the quality of life for patients with orthopedic injuries, illnesses, or disorders.
Some examples of orthopedic medical products include:
- Orthotics: Devices used to support, immobilize, or correct specific parts of the body. This can include cervical collars, ankle braces, knee braces, and wrist splints.
- Prosthetics: Artificial substitutes for body parts that have been amputated or did not develop properly. Orthopedic prosthetics include artificial limbs such as legs or arms.
- Rehabilitation Equipment: Many products are designed to aid in the rehabilitation of orthopedic injuries, such as exercise balls, resistance bands, balance pads, and physical therapy equipment.
- Traction Devices: Devices used to relieve pressure on the spine by gently stretching it. This can be useful for treating intervertebral disc problems or alleviating back pain.
- Immobilization Devices: Plaster casts, bandages, and other forms of devices used to immobilize areas of the body that need time to heal after an injury or surgery.
- Orthopedic Implants: These include hip, knee, and other joint prostheses, as well as plates and screws used in surgeries to fix fractured bones.
- Orthopedic Footwear: Shoes specially designed to provide additional support, cushioning, and correction for patients with foot, ankle, or knee issues.
- Surgical Instruments: Specialized tools used by orthopedic surgeons to perform complex procedures, such as implanting prostheses or correcting deformities.
Just like medical devices, orthopedic materials are classified by risk according to RDC No. 751/2022. Therefore, it is necessary to assess the usage instructions and their specificities in order to determine if conformity certificates, such as INMETRO certification, are required.
Regarding orthopedic implants, this category encompasses all implantable medical products with orthopedic purposes, which are directly used for joint replacement, bone synthesis, ligamentoplasty, and functional maintenance of the human spine. Similar to in vitro diagnostic devices, it is possible to group them into
families and systems for registration purposes, with RDC No. 59/2008 being the resolution that establishes the procedures to be followed.
Concerning the registration of orthopedic products with ANVISA, the technical dossier is assembled based on the product’s risk class. It is crucial to construct well-prepared documents in order to avoid rejection of the process by the Health Surveillance. Among common causes of rejection, the following can be listed:
- Absence of documents digitally signed by the Legal and Technical Representatives in accordance with the company’s AFE;
- Presence of sections (seals, phrases) in another language without sworn translation;
- Failure to provide evidence of product safety and efficacy requirements; and
- Issuance of a manufacturer’s statement without a phrase acknowledging compliance with the requirements of RDC No. 665/2022.
Ensuring that the technical dossiers and information meet the required specifications is essential to prevent the loss of financial resources in new processes and also to save time, especially as of September 2023, when the waiting time for the analysis queue for the registration of implantable orthopedic materials is 9 months.
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