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As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.
New regulations affecting classification of vitro diagnostic (IVD) devices in Brazil will take effect in May.
RDC 61/2011 (Portuguese only) will replace RDC 206/2006 as of May 18, 2012. The new regulation will change the classifications of Class I, II, III and IIIa IVD devices to Class I, II, III and IV. IVD reclassifications will be more aligned with Global Harmonization Task Force risk-based classification criteria.
Emergo Group will provide additional details as they become available.
Brazilian medical device market regulatory ANVISA has announced tighter controls over sales of breast implants in the country following revelations of defective implants manufactured by French firm Poly Implant Prothese (PIP).
According to the Chicago Tribune, Brazilian regulators will require INMETRO quality control certification for all breast implant products; implants will be evaluated for physical strength, tear resistance and toxic materials.
ANVISA will allow manufacturer to choose either certification via pre-market testing on batches of their devices or on-site inspections of production processes. On-site inspections of implant production processes will occur separately from routine facility inspections conducted by ANVISA, the Tribune explains.
All new Brazilian market entrants selling breast implants will have to comply with the new rules. As for implant manufacturers already on the Brazilian market, these firms will have to comply once their current five-year device registrations come up for renewal.
Medical device manufacturers interested in submitting comments to Brazilian regulator ANVISA regarding proposed new grouping criteria have until May 8 to do so.
The regulator began soliciting public comments April 8 on specific criteria for grouping health supplies into families for registration and cadastre purposes. The proposed rules are available on ANVISA’s website (Portuguese only).
Interested parties may email comments to tecnologia [dot] produtos [at] anvisa [dot] gov [dot] br with the subject line “Specific Requirements for Grouping Health Supplies in Families for Registration and Cadastre.” Firms can also fax comments to +1.61.3448.1058, or send written comments to the following address:
National Health Surveillance Agency
General Management of Technology Products for Health
SEPN 515, Bloco B, Ed Omega
Asa Norte, Brazil 70770-502
Brazil’s National Agency for Sanitary Surveillance (ANVISA) will purportedly begin charging inspection fees for Certificates of Good Manufacturing Practice and Quality Control (Brazil GMP) every two years rather than on an annual basis.
According to the Brazilian Association of Equipment Importers, Products and Medical Supplies (in Portuguese), ANVISA’s move is intended to clear up confusion stemming from § 1 of Article 1 of Law No. 11972 established in 2009, which mandated annual quality system inspection fees even though Brazil GMP certification is renewable on a two-year basis. The regulator ratified requirements on March 22; collection rates now coincide with validity timeframes.
During years in which Brazil GMP quality system inspection is not scheduled, manufacturers should perform self inspections and submit reports of those inspections to ANVISA.
The Brazilian National Congress’s Committee on Constitution and Justice and Citizenship has approved the incorporation of medical treatments and equipment into new reimbursement rules under the country’s public health care system, Unified Health System (SUS).
According to Emergo Group consultants in Brasilia as well as Brazilian press reports, the new proposal still requires presidential approval prior to implementation. The new rules will allow health care providers to submit requests for new treatments, drugs and devices to the SUS’s National Incorporation of Technologies unit for review; reviews should take no more than 270 days to complete, after which products gaining approval will be published in the SUS’s reimbursement tables. If the review period for a particular device exceeds the 270-day period, that device will be published by the SUS until the completion of the review.
Proponents of the measure in the Brazilian government have cited the need for clearer regulatory parameters in order to facilitate faster uptake and support of—and thus reimbursement for—new and better medical technologies by the SUS. (Current health care reimbursement rates in Brazil have been characterized as highly inadequate and cumbersome.)
Industry impact: Setting in place a more regimented and (hopefully) efficient reimbursement process in Brazil should make it easier for health care providers to utilize cutting-edge medical devices in their treatment regimens, boosting demand among public health system professionals now able to seek financial support from the government for such products.









