ACCSQ-Medical Devices Product Working Group

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Introduction

ASEAN Consultative Committee for Standards and Quality - Product Working Group on Medical Device (ACCSQ-MDPWG)

The ASEAN Consultative Committee for Standards and Quality was formed by the ASEAN Economic Minister in 1992 with the aim of removing technical barriers to trades in order to facilitate the implementation of the Common Effective Preferential Tariff (CEPT) Agreement to realize the ASEAN Free Trade Area (AFTA).

At the 4th Senior Economic Officials Meeting (SEOM) held in Medan , Indonesia on 8-10 September 1997, the SEOM authorized ACCSQ to involve regulatory bodies in order to achieve its mandate of eliminating technical barrier to trade. During the 24th ACCSQ Meeting on 3rd to 4th August 2004, the formation of a Product Working Group on Medical Device (ACCSQ-MDPWG) was proposed to implement specific measures on medical device under the roadmap for healthcare integration. This is to be in-line with the decision of the ASEAN Leaders on the establishment of the ASEAN Economic Community (AEC) by the year 2020 and fast- track integration of the eleven priority sectors including healthcare sector. The ACCSQ-MDPWG proposal was approved by the SEOM I/36 held on 17-19 January 2005 in Yogyakarta , Indonesia.

Objectives and Scope of the ACCSQ-MDPWG

The MDPWG will assist the ACCSQ in implementing specific measures to facilitate the integration of the medical devices sector through elimination of technical barriers to trade in ASEAN. These measures, among others, include the following:

1	Developing a common submission dossier template for product approval in ASEAN
2	Exploring the feasibility of an abridged approval process for medical devices which regulators of benchmarked countries or recognized regulators have approved
3	Exploring the feasibility of adopting a harmonized system of placement of medical devices into the ASEAN markets, based on a common product approval process
4	Formalizing of a post-marketing alert system for defective or unsafe medical devices.
5	All ASEAN countries to consider joining the Asian Harmonization Working Party (AHWP) and work in parallel with the Global Harmonization Task Force (GHTF) on technical harmonization efforts

The structure of ACCSQ-MDPWG within the ASEAN Economic Minister Meeting

Definition of Medical Device

`Medical device' means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator,
software, material or other similar or related article:

a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

-	diagnosis, prevention, monitoring, treatment or alleviation of disease,
-	diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
-	investigation, replacement, modification, or support of the anatomy or of a physiological process,
-	supporting or sustaining life,
-	control of conception,
-	disinfection of medical devices,
-	providing information for medical or diagnostic purposes by means of in-vitro examination of specimens derived from the human body;

and

b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.

Note 1: The definition of a device for in vitro examination includes, for example, reagents, calibrators, sample collection and storage devices, control materials, and related instruments or apparatus. The information provided by such an in vitro diagnostic device may be for diagnostic, monitoring or compatibility purposes. In some jurisdictions, some in vitro diagnostic devices, including reagents and the like, may be covered by separate regulations.

Note 2: Products which may be considered to be medical devices in some jurisdictions but for which there is not yet a harmonized approach, are:

-	aids for handicapped people,
-	devices for the treatment/diagnosis of diseases and injuries in animals,
-	accessories for medical devices (see Note 3),
-	disinfection substances,
-	devices incorporating animal and human tissues which may meet the requirements of the above definition but are subject to different controls.

Note 3: Accessories intended specifically by manufacturers to be used together with a 'parent' medical device to enable that medical device to achieve its intended purpose should be subject to the same GHTF procedures as apply to the medical device itself. For example, an accessory will be classified as though it is a medical device in its own right. This may result in the accessory having a different classification than the 'parent' device.

Note 4: Components to medical devices are generally controlled through the manufacturer's quality management system and the conformity assessment procedures for the device. In some jurisdictions, components are included in the definition of a 'medical device'.

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