EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2014

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34 | Spring 2014 European Medical Device Technology emdt.co.uk markets branches. Philips, in particular, is expand- ing investment in its ultrasound production facilities, trying to reach the domestic con- tent requirement of 60% to qualify for the benefits granted to locally manufactured medical technology. Market access for foreign medical device manufacturers can be difficult, however, because administrative obstacles for importers remain high. Admission requirements continue to cause significant delays, for example. As a result, manufac- turers and Brazilian consumers alike end up at a disadvantage. Doctors, for exam- ple, often observe the impact of innovative products and techniques launched abroad for months or even years before they are permitted into their own market. Audits are also hindering market access. In 2010, the Brazilian licensing authority ANVISA introduced an audit according to Brazilian GMP for all medical technology products. While the procedure is overall very similar to ISO 13485 standards, which applies in Europe, Japan, Australia/ New Zealand and Canada, problems arise with regard to the delayed assignment of these audits. This delay has a signifi- cant impact on the manufacturers' time and expenses. It also presents particular challenges for small and medium-sized businesses, ultimately resulting in not introducing their products to the Brazilian market at all, in some cases. ANVISA has repeatedly announced its commitment to diminishing these delays by raising the number of investigators and standardizing training. Overcoming the staffing shortage would be a step in the right direction; but, given the wide range of product categories within ANVISA's jurisdiction, it remains to be seen how many of these news posts will actually be deployed in auditing medical technology products. In a recent position paper, German industry association SPECTARIS sug- gested three possible approaches to tackling the problem: In the short-term, authorities could agree on a transition period, during which ANVISA recognizes existing ISO 13485 certificates until an audit in accordance with Brazilian GMP can be conducted. This way, the delay Market access for foreign medical device manufacturers can be diffcult because administrative obstacles for importers remain high ES431022_EMDT1405_034.pgs 04.29.2014 04:33 UBM black yellow magenta cyan

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