by
Joan Trombetti, Writer | November 12, 2008
Plans for an Association of Southeast Asian Nations (ASEAN) medical device directive (AMDD) could bring tighter regulation and harmonization to the region's device market.
The proposed 18-article directive would cover a broad scope of activities - from registration and placement of devices on the market to conformity assessment and creation of a postmarket alert system.
Manufacturers would be required to register with the national regulatory authorities in whose markets they do business and to provide a comprehensive package of technical documents on their products.
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According to an outline of the first draft, prepared by Singapore's Health Sciences Authority (HSA), conformity assessments will cover quality management systems, technical documentation, postmarket surveillance, declaration of conformity and registration of devicemakers and their products. A reference to ISO 13485, which lays out quality management systems requirements for medical devices, will be included in the directive, the HSA said.
Member countries will hold national public consultations on the draft AMDD beginning this month and running through next April. The Medical Device Product Working Group hopes to finalize the directive by 2010.
