Passing Brazil’s Inspections to Take Product to Market

With a population of more than 190 million people and a number of medical device companies interested in conducting business in its maturing healthcare system, Brazil represents the largest medical equipment market in South America and one of the largest markets in the world. To conduct business there, manufacturers will face a progressive regulatory approvals system (including mandatory device registration). Because the Brazilian market represents such a significant prospect, orthopaedic device manufacturers can benefit from understanding the regulatory requirements and the registration and certification process for their products. This article explains the Agencia Nacional de Vigilancia Sanitaria (ANVISA) foundation upon which the regulatory framework is established. I call upon years of defending this challenge to orthopaedic companies to help explain the logistics of planning for and administering this type of inspection.

Over the past few years, I have had the opportunity to help orthopaedic medical device companies prepare for and logistically manage inspections conducted by ANVISA (Created by Law # 9.782). This Brazilian Agency was established in 1999 to control medical devices classified as high risk. (In Brazil, health products such as devices are categorized into four levels of risk, I and II being low risk, and III and IV classed as high risk.) ANVISA is designated an autonomous agency operating under a special regime. This means that ANVISA is an independently administered, financially-autonomous regulatory agency managed by a Collegiate Board of Directors, comprising five members. Presently, there are more than 3,300 medical devices manufacturers registered worldwide with ANVISA to enable the import of their medical devices into Brazil. In order to import and distribute a medical device in Brazil, the medical device must be registered with ANVISA. The length of time between filing an application for registration and final approval by the government varies, but often takes three months to two years to complete, depending upon the complexity of the device and the quality and sufficiency of information accompanying the submission.

The institutional purpose of the agency is to foster protection of the health of the population by exercising sanitary control over production and marketing of products and services subject to sanitary surveillance. Sanitary surveillance of imported orthopaedic devices embraces premises and manufacturing processes, as well as the range of inputs and technologies concerned with the design and development. ANVISA is strategically aligned with the priorities of the Brazilian Foreign Affairs Policy (PEB) and the guidelines of the Brazilian Health Policy to: 

• Promote solidarity among nations
• Focus on strengthening partnerships with other countries
• Strengthen institutional representation with other Regulatory Agencies
• Promote new spaces for regulatory cooperation
• Promote the exchange of information and experiences between regulators and World Health Organization (WHO) regional offices

Presently, ANVISA focuses inspections on medical device companies manufacturing products of class risk III and IV. (Risk classification based on GHTF guideline SG1-N15:2006)

Submission Requirements for Medical Devices

For medical devices classified as Class I or II, the importer or distributor must:

• Pay an inspection fee to ANVISA 
• Complete a registration form available from ANVISA

For Class III and IV devices, the importer or distributor must provide the following documentation:

• A copy of payment bank receipt provided by ANVISA
• Identification of the manufacturer or importer of medical device
• A copy of authorization of the manufacturer to import and market its medical device in the country
• A copy of registration or certificate of free trade or equivalent document issued by the competent authority where the product is manufactured or marketed
• A copy of the certificate of accomplishment of legal requirements determined by technical regulations, in the format of ANVISA’s legislation for medical products
• Documentation indicating that the device complies with the essential principles of safety and effectiveness established by Brazil

The Inspection Requirement

ANVISA announced that as of May 2010, it would require plant inspections of all medical device manufacturers marketing Class III and IV products in Brazil, and would no longer accept cGMP-QSR certificates issued by the U.S. Food and Drug Administration or ISO 13485:2003 certification (the latter necessary for CE Marking). Brazilian regulation, which came into effect in May 2010, set forth an inspection scheme for these manufacturers. In the event of a satisfactory result, the relevant company receives a certificate. In the case of a negative result, the procedure will be terminated and the manufacturer is not awarded a certificate. FDA is not contacted in either case.

Process Notes and Logistics

Inspection Schedule – Once the schedule has been confirmed, a copy of this schedule is sent to the importing company. The date arranged for the sanitary inspection will not exceed a period of 60 days following approval of the written application for the inspection to take place.

Carrying out the Inspection – The team responsible for carrying out the inspection will comprise two members of the technical staff of the Office of Inspection. After completion of the inspection in the relevant production plant, a technical report is drawn up containing information regarding the hygiene and sanitary conditions found in the plant and a conclusive recommendation for or against the issuing by the Brazilian Sanitary Surveillance Agency of the Certificate of Good Practice of Production and Control for the Purpose of Authorization. In the event of non-recommendation, the respective company is not awarded this certificate.
The final result of the inspection will be sent by the Office of Inspection and Control of Food Risks to the interested companies and to the General Office of International Affairs. The latter is responsible for dispatching the result to the sanitary authority of the country of origin.

Procedures for Inspection of Premises in the U.S. – The importer (with the approval of the producer in the case of a contract manufacturer) makes contact with ANVISA on the appropriate form and pays the relevant fee. After completing the inspection, the Foods General Office communicates the result of the same to the General Office of International Affairs of ANVISA and the interested companies, and the General Office of International Affairs informs the Sanitary Authorities of the country of origin of the result.

A Typical Agenda of Topics Covered During an ANVISA Inspection

The scope of the pre-license inspection includes verification of compliance with the following ISO-aligned topics:

Day One 
• ANVISA audit activities and presentations
• Company overview – in relationship to the customer’s responsibilities
• Tour of facilities – plant overview, warehouses, manufacturing areas, QC areas
• Quality manual review (sometimes the quality manual is reviewed prior to arrival)
• Organizational chart
• Document control and quality records
• Human resources (job descriptions, hiring practices, training, competency determinations)

Day Two 
• Quality System Management review
• Internal audits
• Design controls/history file
• Process validation
• Device Master Record
• Change controls

Day Three 
• Purchasing controls – incoming products
• Identification and traceability
• Tour of raw material/components warehouse
• In-process and final inspections
• Non-conforming product
• Manufacturing controls
• Labeling controls

Day Four 

• Final release of medical device(s)
• Device history record review
• Tour of manufacturing and finished goods warehouse
• Environmental controls (clean rooms and environmentally controlled rooms)
• House-keeping (cleaning, pest control, building maintenance)
• Calibration and preventative maintenance

Day Five 
• Handling, storage, distribution, delivery
• Field service – as applicable
• Complaint handling
• Audit findings discussion (ANVISA auditors only)
• Closing meeting and final comments

In Conclusion

For all registrations a Brazilian GMP certificate must be provided as issued by ANVISA. Severe penalties are incurred by companies that do not comply with the requirements listed above, including assessment of stiff fines and even confiscation of medical devices and equipment. Therefore, it is critical that U.S. exporters of medical devices and equipment coordinate the transaction closely with the Brazilian importer. U.S. companies should retain the services of a reputable Brazilian customs brokerage firm with significant experience related to import of medical equipment.

Before being visited by an ANVISA inspector, your company should have in place an inspection procedure that prepares for any eventuality. Your procedure should detail company policy regarding an inspection and, very importantly, designate those individuals who will work with the inspector. Try to anticipate situations and have written procedures covering them. These procedures will provide continuity and help assure that corporate policies are followed by employees receiving and accompanying the ANVISA team.

Each person designated as an ANVISA contact should be chosen carefully and be thoroughly familiar with the inspection procedure and company operations. The contact should be familiar with the ISO 13485 Standards and practices and be able to anticipate problems or requests. These contacts should be knowledgeable about plant operations and able to answer or obtain answers to the inspector’s questions. Having accurate and complete knowledge of what an inspector has done is an important part of handling an ANVISA inspection. Good notes written by a designated individual on the inspection team will be used to record this information. Comments and suggestions made by the inspector’s unanswered questions and promises should all be recorded. General information on the areas of the plant the inspectors visited, to whom he or she spoke, etc., can help when answering findings with corrective action plans, making corrections to the facilities or QA system, or advising top management of the results of an inspection.

The final step for your company is to determine what can be learned from the inspection so that the business can operate in a better state of control, improve quality assurance and ensure future compliance.

For more on Brazil, read our Q&A with orthopaedic professionals based in the country.

John Gagliardi has had success over the past 40 years in the Medical Device and Pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. John specializes in building systems in a compliant and business-ready manner. John can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..

MidWest Process Innovation, LLC
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