Brazil

Cadastro

“Cadastro” is an admission procedure for medical devices of lower risk classes. Its documentation requirements are simplified.

Registro

For medical devices of higher risk classes the more extensive admission procedure “registro” has to be used. According to this a GMPC (good manufacturing and control practice) certificate of the ANVISA is needed. To get this ANVISA has to audit the manufacturer’s facilities.

Inmetro certificate for medical electrical devices

On June 21st 2011 The ANVISA stated, that the approval of medical electrical devices requires an evidence of safety (according to IEC 60601). Not only the product, but also the quality management system gets audited by an approved Brazilian certification center.

China

Following the issue of the State Council Order #650 in 2014, CFDA makes concreted efforts to continuously straighten out, revise and reform the Chinese medical device regulation system by releasing more regulations, guidance, national and industry standards. CFDA focuses on shaping two major aspects of the device industry in China: clinical data requirement and the supervision of the entire device development life cycle. The manufacturers have to meet this big challenge to fulfill and comply with tighten CFDA regulatory rules.
PROSYSTEM is the solid bridge between the manufacturers and the CFDA. We work closely together with CFDA and are familiar with the updated regulatory requirements for the device certifications in China. We assist the manufacturers in achieving different CFDA regulatory pathway milestones such as device clinical evaluation report, device GCP, China device clinical trial audit, manufacturer inspections, and device post-market surveillances. We develop strategies together with the manufacturers to streamline the device registration procedures in this emerging market.

Canada

The market for medical devices in Canada is observed by “Health Canada”. This institution is comparable to the US Food and Drug Administration or the ANVISA in Brazil. Medical devices are classified to one of four risk classes (I, II, III, IV) according to CMDR (Canadian Medical Device Regulation). The regulatory afford for manufacturers depends on the product’s classification.
If your company is not present in Canada, you need a local representative available for Health Canada. Medical devices have to be registered at Health Canada and for a successful approval you need sundry technical documents. This includes the intended use, risk management, clinical assessment, the user manual and applicable declaration of conformity. With the exception of low-risk medical products a license from Health Canada is needed to put a product on the market. For products of class II or above a quality management system according to ISO 13485 is required.
PROSYSTEM gives you support to a successful approval of your medical product on the Canadian market. Starting with product classification and the search for a local representative, across summary of technical documentation and implementation of a quality management system, right up to post-market surveillance activities, we are at your side.