Emergo Podcast: ANVISA medical device approval in Brazil

June 25, 2015 By MassDevice Leave a Comment

By Stewart Eisenhart, Emergo Group

Brazil’s medical device market offers significant growth potential for foreign manufacturers, but the country’s device approval process is challenging.

In this podcast, Emergo Vice President of Business Development Ann Marie Boullie provides an overview of Brazil’s regulatory requirements for medical device registration, including:

Determining your device classification based on ANVISA recommendations
Brazil Good Manufacturing Practice (BGMP) quality management system compliance
INMETRO certification for certain types of medical devices
Brazil Registration Holder (BRH) authorized representation for foreign manufacturers

Additional Emergo resources for medical device companies interested in the Brazilian market include our video overview of Brazilian registration, our regulatory chart of the ANVISA approval process, and our whitepaper on BGMP QMS implementation.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

Only a Few More Days to Register for the most anticipated conference of the winter!

DeviceTalks West is just a few days away. Join more than 300 of your peers for a day of world-class education, networking, and a technology exhibition featuring the leading companies in the industry.

Don’t miss out on this premier opportunity to come together and share perspectives with the best of the best in the industry.

REGISTER NOW

Use code LASTCHANCE to save an additional 20%.

Strata Skin Sciences adds license for excimer laser vitiligo treatment
Strata Skin Sciences(NSDQ:SSKN) said it has reached an agreement with an “internationally acclaimed health institution” giving Strata an exclusive license to treat vitiligo using its Xtrac excimer laser. In a novel treatment for vitiligo, the excimer laser incrementally increases the light emitted in the UVB range to restore pigmentation to skin areas affected with vitiligo.… […]
5 questions you need to ask when engaging a medical device outsourcer
A methodical, structured process is key when lining up a medical device outsourcer. That was one of the top takeaways from a webinar that Medical Design & Outsourcing held with top officials at contract manufacturing giant Integer last week. “It’s time well spent to do your due diligence, to dig into these details, and to… […]
In2Bones intros ‘see-through’ implant for flat feet
Orthopedic surgical device developer In2Bones announced the global launch of its “see-through” PitStop implant for children and adults with flat feet. One of the most common foot deformities, flat-foot often starts during adolescence and continues into adulthood. In2Bones (Memphis, Tenn.) developed the PitStop subtalar implant to restore the stability of a patient’s arch during the walking process. Get… […]
Olympus fined $85 million in duodenoscope case; former exec faces prison
Olympus (TYO:7733) and a former senior executive in Japan have pleaded guilty in Newark, N.J., to failing to file required adverse event reports involving infections connected to duodenoscopes, and to continuing to sell the devices in the United States despite those failures, the Justice Department announced. Tokyo-based Olympus and Hisao Yabe, 62, both entered guilty pleas before… […]
Cardinal Health launches supply chain solution
Cardinal Health has launched a supply chain automation solution that is designed to address the challenges in the operating room. The single health system-wide platform allows hospitals to streamline OR processes, reduce costs and improve efficiency with real-time inventory visibility and prescriptive analytics. The system also offers real-time insights and wrap-around logistics. “We recognized that… […]
Millar wins expanded CE Mark for Mikro-Cath pressure catheter
Millar has received a CE Mark approval expansion for its Mikro-Cath Pressure Catheter. The expansion now includes airway and intra-compartmental pressure measurements. The new expansion will give physicians the opportunity to make improvements in respiratory care while delivering a continuous monitoring technique for measuring compartment pressure and diagnosing acute compartment syndrome at onset. Mikro-Cath can… […]
How technology can ensure MDR compliance – and better business performance
The mid-2020 deadline for MDR compliance is getting closer. Here’s how companies can use technology to ensure compliance. Melonie Warfel, Veeva Systems As we enter 2019, the mid-2020 deadline for the Medical Device Regulation (MDR) is getting closer. It will change the rules for medical device manufacturers and distributors operating in Europe, replacing the current… […]
FDA grants breakthrough status to joint Merck-Bayer AI program
Merck and Bayer have been granted FDA Breakthrough Device Designation for the collaborative Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Artificial Intelligence Pattern Recognition software. CTEPH can be difficult to diagnose because its symptoms are similar to asthma and chronic obstructive pulmonary disease symptoms. CTEPH affects five people per million annually worldwide. Computed tomography pulmonary angiography and… […]
Nexxt Spine launches Saxxony posterior cervical spine system
Nexxt Spine has received FDA 510(k) clearance and has commercially launched its Saxxony Posterior Cervical Thoracic System. The system is designed to stabilize cervical (C1 to C7) and thoracic (T1 to T3) spinal segments through posterior screw fixation. “The Saxxony System adds a robust posterior complement to our well received anterior cervical fixation offering as… […]
MICROMO launches miniature gearheads with integrated leadscrews for linear actuation
MICROMO has launched a new series of linear actuators that feature standard gearheads with an integrated leadscrew that allow for any rotary motor to produce linear micro motion. The company suggests that the gearheads with integrated leadscrew offer a cost advantage to engineers and also provide a more compact motion solution when compared to conventional… […]
How Reggie Groves reinvented Medtronic’s atrial fibrillation biz
Reva Medical (ASX:RVA) CEO Reggie Groves got her start in the medical device industry at medtech titan Medtronic. In her upcoming keynote interview at DeviceTalks West, Groves will discuss how that experience has shaped her as a leader and an innovator. Here’s a preview: When Reggie Groves joined Medtronic (NYSE:MDT) in 2002, she didn’t know very much about… […]