Services
Summary of our consulting services
Regulatory Approval of Health Products
- Registration and notification of medical devices.
- Registration and certification of in vitro diagnostic products (IVD).
- Regulatory approval of self-tests (HIV, glucose, Covid-19, etc).
- Registration of software as medical devices (SaMD).
- Update and maintenance of registrations with ANVISA.
Certification and Compliance
- Mandatory certification of equipment under health surveillance regime (RDC 549/2021).
- Compliance with technical standards (IN No. 283/2024 and INMETRO Ordinances).
- Consulting for clinical trials involving medical devices.
- Support in conformity assessment processes within SBAC.
Specific Materials and Devices
- Regulatory approval of syringes, needles, and single-use infusion sets.
- Registration of surgical and non-surgical gloves.
- Regulatory approval of orthopedic and breast implants.
- Registration of male condoms and IUDs.
- Consulting for dental whitening products and artificial skin pigmentation.
Good Practices and Inspections
- Implementation of Good Manufacturing Practices (GMP).
- Adjustment of storage and distribution processes.
- Preparation for national and international sanitary inspections.
- Training in traceability and Unique Device Identification (UDI).
Monitoring and Post-Market
- Consulting in Technovigilance (monitoring of adverse events).
- Support in recall processes and safety notifications.
- Continuous regulatory monitoring and updates.
- Risk management and post-market compliance.
Advantages of hiring our services
Specialization
Andraplan is a company specialized in guidance and support with ANVISA.
Experience
We have an experienced team, capable of conducting the process of registration, notification, and authorization of your products.
Complete service
We can provide services ranging from simple guidance to the preparation of all necessary product documentation.
Small businesses
Product consulting is also possible for small businesses. Contact us to learn about our solutions so your company can meet the regulatory requirements for notification, authorization, and product registration with ANVISA.
Reduced costs and suitable timelines
We carry out analyses of the product and the manufacturing process in order to achieve reduced consulting costs and timelines suited to your company’s needs.
List of the main products and services for which we provide consulting services for ANVISA registration, notification, and authorization
In vitro diagnostic products (IVD)
Self-tests (glucose, HIV, Covid-19, etc.)
Software as a medical device (SaMD)
Limulus Amebocyte Lysate (LAL) reagent
Respirators and pulmonary ventilators
Multiparameter monitors
Cardiac defibrillators
Infusion pumps
Hemodialysis equipment
CT scanners and X-ray machines
Diagnostic and therapeutic ultrasound
Neonatal incubators and radiant warmers
Anesthesia workstations
Endoscopic equipment
Dental equipment (intraoral and extraoral X-ray devices, dental chairs, suction units)
Phototherapy and light therapy equipment
Peritoneal dialysis equipment
Surgical tables and surgical lighting
Hospital beds
Sterile single-use hypodermic syringes
Hypodermic and gingival needles
Transfusion and infusion sets
Surgical and non-surgical gloves
Plastic bags for blood collection and storage
Male latex condoms
Intrauterine device (IUD)
Orthopedic implants
Breast implants
Textile threads with therapeutic properties
Dental whitening agents
Products for permanent artificial skin pigmentation
Hearing aids
Manual and powered wheelchairs
Battery systems and chargers for powered wheelchairs
Medical suction equipment
Assistive products for personal hygiene
How to obtain ANVISA notification, registration, or authorization? Contact us!
Get ANVISA registration, authorization, or notification for your products with our support.
Authorization, notification, and registration will add value to your products!
Let's go!
ANDRAPLAN is your consulting firm for regulatory matters related to INMETRO, ANVISA, MTE/SIT, ANATEL, and MAPA!
E-mail contato@andraplan.com.br