New ASEAN draft Medical Device Directive: Will it create the hoped for economic boost for the region?
The internationally-renowned medical device regulatory expert, Haroon Atchia, has written a critical examination of the draft ASEAN Medical Device Directive
London, 23 May 2013
Haroon Atchia – CEO of the London-based medical device regulatory consultancy Quality First International – has written a critical examination of the draft Association of Southeast Asian Nations (ASEAN) Medical Device Directive (MDD).
The document entitled “Examination of the ASEAN draft Medical Device Directive” explores the proposed new directive and examines questions related to device registration, market placement, controls and responsibilities. In particular, Atchia compares the scope and content of the draft ASEAN MDD with the requirements of the European MDD to help readers who are not familiar with the current ASEAN regulations to understand the draft ASEAN MDD.
The draft ASEAN MDD is expected to produce significant advantages to the economy of the region. It is also anticipated that, over time, the ASEAN MDD will yield the same benefits (as well as drawbacks) as the European MDD. However, the examination identifies considerable improvements needed in numerous fundamental areas before it becomes a workable scheme.
A 3-page summary of the ASEAN MDD is available for FREE download from www.qualityfirstint.com. The summary will also be available in French and German shortly.
The full, detailed report of approx. 150 pages will be published soon.
About Quality First International
Quality First International (QFI) is a London-based medical devices consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. Quality First International provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian, Mexican and Chinese marketplaces. All submissions made by Quality First International have fulfilled the compliance requirements first time round, consistently. Quality First International’s clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting edge, minimally invasive and cardiovascular products and implants.
For further information, please contact: