As per This article
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.
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.
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.
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.
) – Unlike say the situation say for CE marking in the EU. Obviously registration will cost and if you have a large product portfolio – potentially a lot if by a country by country basis (even though HAS guidelines indicate registration via device ‘family’, ‘group’ etc – see Regulator Guidance on their (broken link removed)). I know one driver for this is hospitals etc in the region buying poor quality medical devices because items are based on cost only – and National Authorities now stamping down on this. Thus this requirement for registration and all the documentation required e.g. Common Submission Dossier Template (CSDT). In the case of Singapore HAS, this is I assume their ‘Essential Principles”, which is a rehash of MDD 93/42/EEC Annex I ‘Essential Requirements’.
