As the Brazilian market continues to grow in prominence, ensuring that medical devices meet the highest quality standards is crucial. The Brazilian Good Manufacturing Practice (BGMP) is a regulatory framework established by ANVISA (National Health Surveillance Agency) that plays a pivotal role in ensuring the quality, safety and efficacy of medical devices sold in Brazil. This article outlines the key components of BGMP, steps for compliance, and the significant resolutions impacting the certification process, particularly ANVISA's RDC 687/2022.
What is BGMP?
Brazilian Good Manufacturing Practice (BGMP) regulations are enforced by ANVISA and apply to all Class III and IV medical devices. While Class I and II devices are not subject to BGMP certification, they must still comply with other Brazilian GMP requirements. Manufacturers of Class III and Class IV medical devices, whether local or international, need ANVISA’s BGMP certification before their devices can be registered in Brazil.
Key ANVISA Resolutions (RDCs) on BGMP
ANVISA's Resolutions (RDCs) on Brazilian Good Manufacturing Practices (BGMP) establish the regulatory framework for the medical devices and IVDs. Key resolutions include -
RDC 687/2022, which outlines the specific requirements for BGMP certification and emphasizes compliance with internationally recognized standards. Establishes criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices. enters into force on June 1, 2022. Administrative aspects
RDC 665/2022 further refines the requirements for Class III and IV medical devices, aligning them closely with global practices while addressing unique aspects of the Brazilian market. General aspects of BGMP requirements are covered in this Resolution.
RDC 850/2024: This regulation, effective April 2024, extends the validity of BGMP certificates for MDSAP participants from two to four years, reducing financial burdens for manufacturers by extending the certification renewal cycle.
ANVISA RDC 687/2022 : Brazilian Good Manufacturing Practices (BGMP) Certification for Medical Devices in Brazil
RDC 687/2022 introduced new administrative processes for BGMP certification, allowing manufacturers to submit audit reports from recognized third-party organizations. ANVISA may issue BGMP certificates based on document assessments or on-site inspections, depending on the results of a detailed risk analysis. This Resolution establishes that on-site inspections by ANVISA will continue to happen, after a priority analysis, and that issuing of GMP Certificates may be granted or renewed through the following scenarios:
Document and Audit Report Assessment
Companies with an audit report from a recognized Auditing Organization, issued within the last three years, can apply for certification. The audit must cover the relevant risk classes and production lines. The report should confirm compliance with Good Manufacturing Practices (GMP). If there are non-conformities, action plans must be submitted to ANVISA by the Auditing Organization. In case of any open Non-Conformities, AVISA would raise a request to the applicant. Failure to address these non-conformities can lead to rejection of the certification request.
Document Assessment and Risk Evaluation
Certification can be based on an assessment of documents and a risk evaluation using a tool available on ANVISA's website. This evaluation considers document assessment results, manufacturing complexity, technology used, product risk, and intended use. If there are non-conformities, action plans or proof of corrective actions must be provided. Unresolved non-conformities can result in rejection of the certification request.
ANVISA Inspection Report
Certification can also be granted based on ANVISA's inspection report following an on-site inspection. This applies when the conditions in the previous scenarios are not met, such as in the absence of an audit report or specific risk analysis.
ANVISA Resolution RDC 850/2024
ANVISA introduced RDC 850/2024 to further streamline the BGMP certification process for manufacturers participating in MDSAP. This resolution extends the validity of BGMP certificates from two to four years, provided manufacturers maintain continuous MDSAP participation. This change helps manufacturers reduce the costs associated with certification renewals and aligns Brazilian regulations with global standards. Here are the key highlights of the Resolution RDC 850/2024. The key change brought by RDC 850/2024 is the extension of the BGMP certificate’s validity period from two years to four years, exclusively for manufacturers participating in the MDSAP program.
The resolution came into effect from April 1st, 2024.
The 4-year validity is contingent upon the manufacturer’s continued participation in the MDSAP program during the BGMP certification period.
For BGMP applications submitted before the 1st April 2024 and under evaluation, the extended validity period will apply.
BGMP certificates that have already been issued before 1st April 2024 will be valid for their original 2-year validity.
Only new certificates and renewals will benefit from the extended validity period under the Resolution RDC 850/2024
Which devices are subjected to BGMP Certification ?
The manufacturing units of medical devices of risk classes III and IV that fit one of the conditions are subject to the BGMP Certification:
Manufacturing unit that manufactures a final product or carries out contract manufacturing for another company.
Manufacturing unit that performs the final release of the final product, associated with at least one production stage, excluding design, distribution, sterilization, packaging, and labelling.
The packaging activity for sterile medical devices is considered as a sterile barrier system, is considered as a production stage and is subject to BGMP Certification
The IVD manufacturing units that perform the stages of impregnation, lamination, or cutting of immunochromatography strips
Medical software manufacturing unit (Software as a Medical Device – SaMD).
Who Should Submit BGMP Applications ?
The Brazilian Registration Holder (BRH) must submit the applications for BGMP on behalf of the foreign manufacturers. The BRH will then be the official holder of the certificate issued by ANVISA.
How can one leverage MDSAP Certification?
As a member of MDSAP, ANVISA grants B-GMP certificates after analyzing the audit reports issued by Auditing Organizations that are accredited under the MDSAP program. The percentage of certificates issued based on MDSAP audits has been steadily increasing.
Certificates issued by MDSAP on audits | On-site Inspections by ANVISA |
38 Certificates Issued in 2017 (4.7%) | 238 Inspection (2017) |
107 Certificates Issued in 2018 (19.3%) | 110 Inspections (2018) |
374 Certificates Issued in 2019 (48.7%) | 84 Inspections (2019) |
544 Certificates Issued in 2019 (49.1 %) |
|
529 Certificates Issued in 2019 (51.4 %) |
|
Participation in the MDSAP program is a strategic advantage for manufacturers, as it not only expedites the certification process with ANVISA but now also provides an extended certificate validity compared to BGMP certificates obtained outside the program. The resolution is expected to reduce the financial burden on companies by lengthening the interval between certification fee payments in Brazil.
What are the documents to be submitted for BGMP Certification?
The Brazilian Registration Holder (BRH) must submit the applications for BGMP on behalf of the foreign manufacturers. The request should include –
Duly filled Application form for BGMP Certification
Manufacturing process flowchart for the manufactured products, identifying the stages are carried out in the facility in scope
Manufacturing Facility Layout including the floor plan of the manufacturing unit.
List of all products produced in the manufacturing unit including technical name, production line, and respective risk class. Note: The highest risk medical device manufactured in the facility must be included even if it is not intended for commercialization in Brazil
Statement indicating whether the products that are or will be commercialized in Brazil are regulated in the country of origin and MERCOSUR or IMDRF member countries.
List of all inspections or audits carried out in the last 3 (three) years, indicating the period of each inspection or audit; name of the authority or auditing organization responsible for it; conclusion and details of regulatory actions, if any.
Document attesting compliance or copy of the inspection report used to prove compliance with the Country of Origin GMP Regulations
Copy of the inspection report issued by the health authority of a country that is a member of a ANVISA recognized audit program or a statement confirming that the company participates in a ANVISA recognized audit program, when applicable.
Proof of payment of B-GMP certification
Document No. | Manufacturer located in Brazil* | Manufacturer located in Mercosur Countries** | Manufacturer Participates in ANVISA recognized audit Program# |
1 | Y | Y | Y |
2 | Y | Y | Y |
3 | Y | Y | Y |
4 | Y | Y | Y |
5 |
| Y | Y |
6 |
|
| Y |
7 |
| Y | Y |
8 | Optional | Optional | Y |
9 | Y | Y | Y |
*Inspection reports by the local – state or municipal – health authorities or a Declaration that the unit is participates in ANVISA recognized audit program
**Inspection reports by the local health authorities or a Declaration that the unit is participates in ANVISA recognized audit program
# For manufacturers participating in ANVISA recognized audit program, the audit reports must be made available by the respective Auditing Organization.
Validity of a BGMP Certificate issued by ANVISA
The GMP certificate is valid for two (2) years. The BGMP Certificate issued relying on the MDSAP is subject to renewal every 4 years
Renewal of BGMP Certificate issued by ANVISA in Brazil
The submission for renewal of BGMP Certificate must include all the documents originally submitted other than manufacturing flow chart, facility layout, product list and the plan for commercialization in Brazil. Any changes made in these documents ncessitates submission of revised documentation for renewal fo BGMP Certificate.
Achieving and maintaining BGMP certification is essential for manufacturers looking to enter the Brazilian market. BGMP ensures that medical devices meet rigorous quality and safety standards, thereby protecting public health and enhancing market credibility. By understanding and navigating the BGMP certification process, manufacturers can position themselves for success in Brazil's dynamic healthcare market.
For expert assistance with BGMP certification and compliance, contact Artixio. Our team of specialists is here to guide you through every step of the process, ensuring a smooth and successful certification journey. Reach out to us today at info@artixio.com to learn how we can support your regulatory needs and help you achieve your market goals.
References :
Comentários