Guide to regularization of implantable medical devices

Implantable Medical Devices (IMDs) are medical products designed to be inserted fully or partially into the human body through surgical procedures, with the intention of remaining in place for a long period of time.

Their main function is: to aid in the diagnosis, prevention, treatment or compensation of diseases, injuries or disabilities. Common examples include pacemakers, prostheses, stents and heart valves.

Their use requires strict control and monitoring, and in order to guarantee patient safety, tracking these devices is fundamental to achieving this goal:

• Device history: Provides information on the origin, manufacture and distribution of the device.
• Identification: Makes it easier to identify the product's characteristics in the event of problems.
• Safety: Helps identify possible faults or defects in the device.
• Surveillance: Helps monitor the safety of devices after they have been marketed.

IMDs have revolutionized medicine and brought remarkable advances to society's health and well-being. Implantable Medical Devices allow patients with chronic conditions or who have undergone surgery to lead more active and independent lives, and the possibility of less invasive and more effective treatments contributes to an increase in the population's life expectancy. It is hoped that in the long term, the use of IMDs can reduce health costs by avoiding complications and hospitalizations and also provide patients with a more productive life, both at work and in everyday life. The demand for these devices generates an incentive for research and the development of new technologies, which has an impact on job creation and, consequently, on the economy in a positive way.

Regulation protects consumers by ensuring that they have access to accurate information about products and can make informed decisions about their treatment. The regulations establish strict criteria for the development, manufacture and marketing of Implantable Medical Devices, with the aim of minimizing the risk of failures, infections and other complications.

The regulations also require manufacturers to provide clear and complete information about the devices, including instructions for use, precautions and possible adverse effects. Regulatory agencies such as ANVISA play a key role in this process, setting standards, carrying out inspections and taking measures to ensure that products comply with legislation.

The main stages involved are:

1. Planning and Development: Definition and development of the product.
2. Preparation of the Technical Dossier: Analysis of whether all the documentation complies with the requirements established by ANVISA and the applicable international standards.
3. Submission of the Registration Application: Submission of the complete technical dossier to ANVISA for analysis, and payment of the corresponding fees.
4. Analysis by ANVISA: Anvisa's technical team assesses the documentation submitted, checking that it complies with the legislation and that the product is safe. In some cases, an inspection may be carried out at the manufacturer's premises to check production conditions and quality control.
5. Obtaining registration: Once ANVISA has given its final approval, the product receives official registration, enabling it to be marketed in Brazil. From this point on, the product can be distributed, ensuring that it meets the safety and quality standards required for use on the market.

Stone Okamont is a consultancy specializing in regulatory affairs, which acts as a strategic partner for companies wishing to register their implantable medical devices, offering technical expertise, agility and security throughout the process.