Brazil QMS requirements

for medical device

manufacturers
What you need to know about ANVISA B-GMP compliance

Michael Dun, RAC

Country Manager, Australia
michael.dun@ul.com

April 2019
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Background of
Brazil Good
Manufacturing
Practice

The Brazilian medical device and IVD market is historically complex. The changing legislative
landscape, combined with the lack of resources at the Brazilian National Health Surveillance Agency
(ANVISA), has been a source of frustration for domestic and foreign manufacturers.

However, nothing exasperated manufacturers more than ANVISA’s 2009 decision to introduce
obligatory Brazil Good Manufacturing Practice (B-GMP) quality system certification for medical device
and IVD registration. Although Brazilian manufacturers were previously required to hold B-GMP
certification, ISO 13485 certification or local GMP licenses were sufficient for foreign manufacturers.
Requiring foreign manufacturers to have their quality management systems certified to B-GMP
presented a substantial burden for these firms.

At that time, even the US FDA recognized the resource limitations of its international inspection program. ANVISA had
only nine federal inspectors, yet it ignored the counsel of other regulatory agencies and industry bodies (including Abraidi,
Abimed, and CBDL1) and published the requirement in Resolution RDC 25/2009.

Since 2009, ANVISA has fought an uphill battle with industry, Brazilian federal courts, and a lack of resources. As a result,
the agency made changes to B-GMP applicability. ANVISA also provided additional options for foreign manufacturers to
demonstrate GMP compliance by recognizing auditing organizations participating in the Medical Device Single Audit
Program (MDSAP).

This paper covers current B-GMP requirements and applicability, and indicates recent changes in the B-GMP certification
process relevant to international device manufacturers.

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Comparing Brazil GMP to US FDA QSR and

ISO 13485
When Resolution RDC 25/2009 was published, Brazilian GMP requirements were described in Resolution RDC 59/2000
(medical devices) and Ordinance SVS/MS 686/98 (IVDs), and were largely based on the US FDA Quality System Regulation
(QSR). However, there were a number of key areas and concepts lost in translation. For example, an annexed checklist in
Resolution RDC 59/2000 that indicated the applicability of GMP requirements based upon the device class and nature of
the registrant’s activities (e.g., manufacturing or distribution) caused confusion and contention among inspectors
and manufacturers.

In 2013, ANVISA published Resolution RDC 16/2013 — a single piece of legislation with new B-GMP requirements
applicable to medical devices and IVDs. This resolution dispensed with the controversial annex and integrated QSR and ISO
13485:2003 requirements. Figure 1 shows the correlation between the QSR, ISO 13485:2003, and Resolution RDC 16/2013.

NOTE: We discuss ISO 13485:2016 on page 5.

US FDA QSR Brazil GMP ISO 13485:2016

Subpart A
General Provisions Chapter 1 Clause 1
General Provisions Scope
Subpart B
Quality System Requirements
Chapter 2
Subpart C General Quality
Design Controls Clause 2
System Requirements Normative Reference
Subpart D
Document Controls
Chapter 3
Subpart E Quality Documents & Records
Clause3
Purchasing Controls Terms & Definitions

Subpart F
Identification & Traceability Chapter 4
Design & RMP
Subpart G Clause 4
Production & Process Control Quality Management Systems

Subpart H Chapter 5
Acceptance Activities Process & Production Control

Subpart I Clause 5
Nonconforming Product Management Responsibility
Chapter 6
Subpart J Handling, Storage,
Corrective & Preventive Action Distribution & Traceability

Subpart K Clause 6
Labeling & Packaging Control Chapter 7 Resource Management
Corrective & Preventitive Actions
Subpart L
Handling, Storage, Distribution & Installation

Subpart M Clause 7
Chapter 8 Product Realization
Records Installation & Servicing

Subpart N
Servicing
Chapter 9 Clause 8
Subpart O Statistical Techniques Measurement Analysis
Statistical Techniques & Improvements

Figure 1 – QSR / RDC 16 / ISO 13485 Correlation Chart

Source: Emergo b y UL

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The requirements in Resolution RDC 16/2013, the FDA QSR, and ISO 13485:2003 overlap in many areas, such as the
types of records (e.g., DHF, DMR, DHR, complaint file) and procedures (e.g., training, design control, CAPA, identification/
traceability) required. Some of the differences between B-GMP requirements and FDA QSR or ISO 13485:2003 include:

• Inclusion of specific risk management requirements and terminology/definitions

• The requirement to establish procedures for meeting current legislative requirements
• Specific qualification requirements for consultants
• Historical record of the project (RHP) content
• Specific separation of design transfer and design release activities
• No requirement for an independent reviewer during design reviews
• Requirements linked to biosafety and occupational health and safety

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Harmonization with ISO

13485:2016
The publication of ISO 13485:2016 reduced the differences between ISO 13485
and Resolution RDC 16/2013 even further, particularly as the ISO standard was
revised for further integration with risk management requirements and now includes
specific RHP content requirements. However, a number of differences remain, so full
compliance with Resolution RDC 16/2013 is required.

When required for device registration purposes, adherence to B-GMP is

demonstrated by the presentation of a GMP certificate issued by ANVISA. The
agency issues these certificates through one of the following scenarios, as
established in Resolution RDC 183/2017:

• Presentation of a valid audit report, issued by a third-party auditing organization,

in accordance with specific programs, both recognized by ANVISA;
• From the use of confidential information on inspections, received within the
scope of Agreements or Covenants with sanitary authorities of other countries;
• Assessment of inspection or audit reports issued by the sanitary authority
of an IMDRF member country or by a third-party organization accredited by
the country;
• Assessment of audit reports issued by a third-party auditing organization that
has been recognized by ANVISA;
• Risk analysis to assess the need for the execution of an on-site inspection prior
to the granting of GMP certification, in the case of requests that do not fall under
or meet the requirements established for the above situations.

Therefore, in contrast to the scenario prior to the publication of Resolution RDC

183/2017 whereby all foreign manufacturers requiring B-GMP certification had to
undergo an on-site ANVISA inspection or MDSAP audit, it is now possible that a
foreign manufacturer may not actually require such an inspection or audit in order to
obtain B-GMP certification based upon the risk analysis performed by the agency. When subject to
an on-site ANVISA
The risk analysis performed by ANVISA considers the following information: inspection, all
• Intrinsic product risk; manufacturers will
• Product indication for use;
receive a copy of the
• Complexity of the manufacturing processes;
final inspection report
• Technology involved;
in Portuguese.
• Historical data on inspections, monitoring, and product registration.

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For plants that have been previously certified by ANVISA, the agency will also take the following into consideration during
the risk analysis:

• B-GMP compliance history;

• History of deviations, technical complaints, adverse events, field action notifications, and/or previous sanitary infractions;
• Time passed since the last inspection;
• Product registration status.

There are some important details regarding B-GMP certificates, including the following:

• Certificates are issued for each product line. There are two different product lines defined by ANVISA: (1) Equipment/
materials; and (2) IVDs.
• Certificates are issued for the class(es) of device(s) manufactured.
• Certificates are specific to each Brazil Registration Holder-manufacturer combination. For example, if a manufacturer
already possesses B-GMP certification for one BRH, the manufacturer must obtain a separate B-GMP certificate for a
different BRH.
• Certificates are valid for two years from the date of publication.

At the end of 2016, legislation allowing manufacturers to transfer Brazilian device registrations between different
Registration Holders came into force. While the cooperation of the current Brazil Registration Holder is necessary, it is also
possible to transfer Brazil GMP certificates between Registration Holders. However, registrations for all products covered by
the GMP certificate must be transferred, otherwise a second GMP certificate will be necessary.

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Who must meet B-GMP requirements?

After the publication of Resolution RDC 25/2009, ANVISA found itself in the very situation predicted by industry: a growing
backlog of foreign companies waiting for inspections. The agency increased the size of its team of federal inspectors by
relying on municipal and state branches to handle national inspections, but to no avail. By 2014, the situation was completely
unsustainable. The wait time for foreign manufacturers requiring B-GMP certification increased to five years, the same
amount of time Brazilian device registrations are valid and more than double the time B-GMP certificates are valid (two years).

In an effort to trim this list to a manageable size, ANVISA published Resolution RDC 15/2014 in March of 2014 stating that
B-GMP certification would only be issued and required for manufacturers of Class III and IV higher-risk devices. Regardless
of this change, this same resolution states that all manufacturers selling medical devices or IVDs in Brazil must comply with
B-GMP requirements, regardless of device class.

It is important to remember that some GMP requirements also apply to Brazilian importers and distributors, as outlined in
Normative Instruction 8/2013. Figure 2 identifies applicable requirements for relevant parties. As part of the qualification
process, manufacturers should ensure all relevant parties implement appropriate controls for the applicable
GMP requirements.

B-GMP Applicability for Importers, Distributors, and Warehousers

RDC 16/2013 Importer Distributor Warehouser

Chapter 1 - General Provisions 1.1.2 1.1.2 1.1.2

Chapter 2 - General Quality All All except for 2.4 All except for 2.4
System Requirements

Chapter 3 - Quality Documents 3.1 and 3.3 3.1 3.1

& Records

Chapter 4 - Design Control 4.2.1, 4.2.1.4, 4.2.1.5 Not applicable Not applicable
& RMP

Chapter 5 - Process & 5.1.2, 5.1.3, 5.1.4, 5.1.2, 5.1.3, 5.1.4, 5.4 5.1.2, 5.1.3, 5.1.4, 5.4
Production Controls 5.2.2, 5.3, 5.4

Chapter 6 - Handling, Storage, All except for 6.5.3 All except for 6.5.3 All except for 6.5.3
Distribution &
Traceability
Chapter 7 - Corrective & All All All
Preventive Actions

Chapter 8 - Installation & All applicable All applicable Not applicable

Servicing

Chapter 9 - Statistical Techniques All Not applicable Not applicable

Figure 1 – Source: Emergo by UL

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Companies using OEM
manufacturers or other third parties
for manufacturing activities have
some important considerations
regarding the applicability of B-GMP.
In late 2017, with the publication of
Resolution RDC 183/2017, ANVISA
updated previous requirements
regarding the applicability of B-GMP
certification for legal and contract
manufacturers. Combined with the
changes of Resolution RDC 15/2014,
B-GMP certification applicability for
legal and contract manufacturers can
be outlined as:
*Final product is defined by ANVISA as being a single product, family, system, or set that is apt for use or functionally complete, that may or
may not have undergone packaging, labeling, or sterilization.
1. Manufacturing plant that While GMP certification is
produces a final product* in its only issued for Class III and IV
name or for another company; manufacturers, manufacturers of
Class I or II devices should remember
2. Manufacturing plant that
that ANVISA inspectors can write up
performs final release of
nonconformities against
product, associated with at least
B-GMP requirements.
one production step, excluding
the steps of design, distribution,
sterilization, packaging and
labeling; and
3. Manufacturing plant for medical
software (Software as a Medical
Device — SaMD).
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What is the submission process?
If you require B-GMP certification,
a request for certification must be
formally filed with ANVISA for each
facility. The documentation required
for ANVISA submission includes:
• A completed copy of the
ANVISA B-GMP certification
request form (a standard form
available from the agency’s
website that includes such
information as facility and
product details);
• Evidence of payment of the
B-GMP certification fee. For
Brazil and countries that are
Mercosur2 members, there is a
sliding fee scale that depends on
the size of the company, ranging
between 750 and 15,000
Brazilian reais. Manufacturers
from all other countries must
pay a flat fee of 72,806
Brazilian reais;
• Copy of the manufacturer’s
quality manual*;
• List of all of the products
manufactured at the
establishment to be certified,
with an indication of those that
are or will be subject to export
to Brazil*;
*In accordance with ANVISA requirements, documents not provided in English, Spanish, or Portuguese must be accompanied by an English,
Spanish, or Portuguese translation.
• General flowchart of the • Copy of the most recent
manufacturing process for inspection or audit report issued
the products manufactured, by a regulatory authority from
identifying those steps that are an IMDRF member country or
executed at the establishment by an auditing organization
subject to certification*; accredited by this country,
when applicable*;
• Layout of the establishment to
be certified, including factory • Copy of the most recent audit
floor plan*; report issued by a third-party
auditing organization recognized
• In the case of electromedical
by ANVISA, when applicable*.
devices, a copy of their valid
INMETRO certificate;
Once a certification request has
• List of all inspections or audits
been submitted, it enters the queue
performed at the establishment
at ANVISA. Processing times
subject to certification over
can vary, depending upon the
the last three years, with an
circumstances of the manufacturer
indication of audit/inspection
requesting certification. For example,
duration, name of the regulatory
manufacturers presenting MDSAP
agency/auditing organization,
audit reports demonstrating
audit/inspection conclusion,
compliance with B-GMP
and details of any subsequent
requirements can expect processing
regulatory action*;
times of up to three months,
• Declaration that indicates in whereas other manufacturers can
which countries the products expect much longer lead times
that are or will be exported depending upon whether the agency
to Brazil are registered, with has determined that an on-site
evidence of registration*; inspection is necessary.
• Copy of the most recent
inspection or audit report
issued by the regulatory agency
in country of origin or by an
auditing organization accredited
by this agency*;
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Expediting your B-GMP

submission
Industrial bodies took legal action against ANVISA to mitigate the impact on
manufacturers caused by long delays for B-GMP inspections. These actions
presented two submission options for manufacturers.

Abimed decision
In 2010 the industry body Abimed used a legal recourse against ANVISA due to the
significant delays in the processing of foreign GMP plant inspection requests.
In 2012, a federal judge ruled in favor of Abimed. The decision states that ANVISA
must accept evidence of international compliance with GMP or QMS requirements
if the agency has not performed an on-site inspection within six months of receipt of
a GMP inspection request submission, when required for the registration of medical
devices. There are three important caveats regarding this decision:

• Your Brazil Registration Holder must be an Abimed member.

• Although international evidence of GMP or QMS compliance can be
demonstrated for device registration purposes, your facility must still undergo an
ANVISA on-site inspection.
• If the agency determines in their inspection that you do not meet the
requirements of Resolution RDC 16/2013 or that proposed corrective actions are
insufficient, it may revoke your device registrations.

CBDL decision
The second option is known as the CBDL decision, and is even more favorable for
foreign IVD manufacturers. The industry organization CBDL presented a similar
justification as that used by Abimed. In 2013, federal judges found in favor of CBDL
and exempted foreign IVD manufacturers from presenting evidence of compliance
with B-GMP. These organizations are therefore exempt from any inspection and are
GMP certification not subject to the inspection fee charged by ANVISA. For foreign manufacturers to
must be renewed make use of this decision, their Brazil Registration Holders must be
every two years. CBDL members.

For those manufacturers that have been inspected by ANVISA, the audit report
and the agency’s decision regarding the issuance of GMP certification are typically
published within one to three months after the on-site inspections.

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Recent changes to GMP certification

requirements in Brazil
As a member of the International Medical Device Regulators Forum (IMDRF), ANVISA participates in the Medical
Device Single Audit Program (MDSAP), which moved from the pilot to the operational phase at the beginning of 2017.
The program’s purpose is to reduce the need for multiple audits or inspections by allowing a single audit, performed by an
independent auditing organization, to serve as sufficient evidence of quality system GMP compliance recognized by any one
of the participating regulators.

During the execution of the MDSAP pilot program,
ANVISA introduced Law 13,097/2015, which allowed
for the possibility of the agency extending the validity
of Registro registrations from five to ten years and
accepting inspection reports or results issued by regulatory
authorities from other countries or certifying organizations.
These possibilities have entered into force with the
publication of the following regulations:
• Resolution RE 2,347/2015: Recognition of the
MDSAP program for the purposes of Brazil GMP
certification whereby auditing organizations that meet
MDSAP programs are recognized by ANVISA through
the publication of individual legislative instruments;
• Resolution RDC 183/2017: Requirement of the
presentation of audit and inspection reports issued
by regulatory authorities from other countries or
recognized certifying organizations for B-GMP
certification applications;
• Resolution RDC 211/2018: Extension of Registro
registration validity from five to ten years.
• ANVISA acceptance of inspection reports or results
issued by regulatory authorities from other countries
or certifying organizations.
As a result of this legislation, ANVISA began publishing
formal recognition of auditing organizations participating
in the MDSAP program, even during its pilot stage, in
the Official National Gazette beginning December 2015.
Upon publication of this recognition, ANVISA accepts
MDSAP certificates issued by the corresponding auditing
organization in place of the agency performing an on-site
inspection of the manufacturing facility. Currently, the
auditing organizations with formal ANVISA recognition
under the MDSAP program are:

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1. BSI Group America Inc.
2. DEKRA Certification B.V.
3. DQS Medizinprodukte GmbH
4. Intertek Testing Services NA Inc.
5. Laboratoire National de Métrologie et d’Essais (GMED
Certification Division)
6. Lloyd’s Register Quality Assurance Inc.
7. National Standards Authority of Ireland (NSAI)
8. TUV SUD America Inc.
9. UL Medical and Regulatory Services
10. SGS United Kigdom Ltd.
11. NSF Health Sciences Certification, LLC
12. TUV Rheinland of North America, Inc.
For MDSAP certificates to be accepted by ANVISA,
manufacturers must verify with the auditing organization
that applicable Brazilian requirements are within the scope
of the MDSAP audits performed, which will be indicated in
the issued MDSAP certificates.
If ANVISA rejected your GMP certification request due
to nonconformities detected during their inspection, an
MDSAP certificate will not be accepted by the agency in
place of a repeat ANVISA on-site inspection.
ANVISA’s acceptance of MDSAP certificates presents
a faster track for foreign manufacturers to obtain
B-GMP certification. Requests are typically processed
approximately one month from submission, five months
faster than using the Abimed decision and years ahead of
the current waiting list for on-site inspections.
While the agency does accept MDSAP certificates
issued by these recognized auditing organizations,
the manufacturer must still pay the applicable B-GMP
certification fee to ANVISA (every two years) in addition
to the auditing organization fee for the realization of
the MDSAP audit. While there are reduced certification
timeframes, the MDSAP option comes with
added costs.
Beyond MDSAP recognition, ANVISA took a number
of measures in 2017 to address the lengthy wait times
that manufacturers experience as part of the B-GMP
certification process. Specifically:
• The agency began trials of an accelerated on-site
inspection process. Under this process, manufacturers
would supply copies of their quality management
system manual and procedures ahead of the on-site
audit. These would be reviewed by ANVISA and
followed up with an on-site audit conducted over
two-and-a-half days by three inspectors (as opposed
to two inspectors for routine foreign inspection) with
a focus on critical process. This trial was only being
performed in locations where two manufacturers were
located in close proximity (i.e., the same city);
• The publication of Resolution RDC 183/2017, as
previously discussed in this white paper, has provided
greater flexibility to ANVISA’s inspection team and
allows for the agency to perform a risk analysis in
determining the need for an on-site inspection. It also
allows for the execution of desktop inspections to
some extent.
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Summary +
Conclusion

If your organization has discounted the Brazilian market previously due to the barrier of B-GMP certification, now may be a
good time to reassess your stance.

ANVISA has taken great strides over the last two years in addressing the long wait times associated with the B-GMP
certification process. By allowing foreign manufacturers to leverage their MDSAP certification and introducing the possibility
of desktop inspections (based upon risk analysis), ANVISA has greatly reduced the barriers for market entry into Brazil when
compared with other markets.

Now all that remains for the agency to do is to adjust the B-GMP certification fee for manufacturers leveraging their MDSAP
certification to accurately reflect the costs associated with this certification pathway.

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End Notes
1. Abraidi = Brazilian Association of Implant Importers and Distributors ; Abimed = Brazilian Association of High Technology
Medical and Hospital Equipment, Products and Suppliers ; CBDL = Brazilian Chamber of Laboratorial Diagnostics

2. Mercado Comum do Sul or Southern Common Market, comprises Argentina, Brazil, Paraguay, Uruguay and Venezuela.
Associate countries include Chile, Bolivia, Colombia, Ecuador and Peru. Observer countries are New Zealand and Mexico.

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 Learn more
Need help with ANVISA compliance? Emergo by UL helps medical device companies with regulatory compliance and market
access in Brazil and other markets worldwide. Here’s how we can help:

• Device and IVD classification and assessment

• B-GMP implementation and audits

• Brazil Registration Holder service

Learn more about how we can help you with Brazilian medical device compliance at EmergobyUL.com.

About the author

Michael Dun, RAC is the Australia Country Manager and Director at Emergo. He has more than 13 years of experience in
quality systems, auditing, regulatory affairs, and research and development across the biotechnology, IVD, and medical device
manufacturing and services industries. His areas of expertise include QMS implementation and audits, risk management, and
device registration and documentation in the US, EU, Brazil, and Australia.

Emergo by UL and the Emergo by UL logo are trademarks of Emergo Global Consulting LLC © 2019. All rights reserved. This document may not be copied or distributed, in whole or
in part, without express written permission from Emergo by UL. It is provided for general information purposes only and is not intended to convey legal or other professional advice.