In response to the development of trade regionalization, ASEAN member countries have agreed to establish the ASEAN Economic Community (AEC) in 2015 to create a free flow of goods and services in the ASEAN region with the hope of improving the economy of ASEAN member countries. One of the sectors prioritized for ASEAN integration is medical devices, which will be regulated under the ASEAN Medical Devices Directive (AMDD). The medical devices sector plays an important role in the diagnosis, prevention, monitoring, and treatment of diseases and in improving the quality of life.

Indonesia, the world's 4th most populous country and the largest in Southeast Asia, is one of the world's largest markets for medical devices and healthcare. Imports of medical devices in Indonesia account for 97% of the market. Indonesia has more than 222 medical equipment manufacturers of which 90% are MSMEs that produce primary medical products such as surgical gloves, bandages and orthopedics, said the Chairman of the National Accreditation Committee (KAN), Prof.Dr. Bambang Prasetya when giving his speech at the Socialization of Medical Device Quality Management System Accreditation at Grand Sahid Jaya Hotel, Jakarta (25/02/2014).

The Socialization event was attended by approximately 70 people who were representatives of LSSM, LSPro, Association of Indonesian Certification Bodies (ALSI), ASPAKI, Association of Medical Devices and Laboratories (GAKESLAB), Ministry of Health, as well as Assessors and Technical Committee for Accreditation in the field of LSSMMAK from the National Accreditation Committee - KAN. Furthermore, Bambang Prasetya said that the development of a conformity assessment system is very necessary considering the role of this system in providing assurance of competence and or suitability of products, services, or systems in accordance with requirements or standards which in turn can increase the acceptance and certainty of products / services in trade transactions.

Assurance of conformity with standards/quality is key in efforts to improve product competitiveness, it is also a guarantee in efforts to protect the public in terms of health, safety and the environment. KAN conducts competency assessments of certification bodies to certify management systems, products, and personnel in all sectors of trade. Certification bodies must apply and uphold the principles of impartiality, competence, responsibility, openness/transparency, confidentiality, and responsiveness to complaints in the entire selection, determination and attestation process.

The accreditation and certification scheme for the quality management system of medical devices was launched on October 17, 2013 by the Director General of Pharmaceuticals and Medical Devices together with the Chairman of KAN and the Secretary General of KAN at the Indonesia Quality Expo at the Jakarta Convention Center. The KAN accreditation and certification scheme for Medical Device Quality Management System (SMMAK) is based on the international standard ISO 13485 which has been adopted as SNI ISO 13485.

With this scheme, we hope to facilitate business actors in proving their conformity to the consistency of products and services produced according to customer requirements and applicable regulations so that in the end they can increase the competitiveness of national products, said Bambang ending his speech.

Entering the panel discussion session, this activity presented 3 speakers, namely Dra. Lili Sadiah Yusuf, Apt. from the Directorate of Production and Distribution of Medical Devices, Ministry of Health RI, Konny Sagala, Director of Accreditation of KAN Certification Bodies, and Weni Widjajanto from ALSI, and moderated by the Head of Management System Accreditation-Center ALS BSN, Triningsih Herlinawati.

In her presentation on Regulations Related to the Quality Management System of Medical Devices, Lili Sadiah Yusuf, Apt explained the basic legal regulations related to health and medical devices. She also revealed that Indonesia is the country with the largest population in ASEAN, where Indonesia's economic level is getting better and is predicted to continue to increase, so that health programs are needed which require a lot of medical devices.

In addition, Lili Sadiah also explained how to anticipate the era of free trade, as well as how Indonesia is preparing for the implementation of AEC in 2015 where manufacturers of medical devices marketed in ASEAN are mandatory to implement ISO 13485.

In the next session, Konny Sagala explained about the SMMAK Accreditation and Certification Scheme. Konny explained several things related to this scheme such as the flow of the accreditation process, reference requirements of the SMMAK accreditation and certification scheme, reference requirements for medical device manufacturers, SNI ISO 13485: 2003 including its contents and requirements, steps to obtain certification from LSSMMAK, as well as reference requirements for LSSMMAK.

The last presentation, Weni Widjajanto discussed the Development of SMMAK Certification. This socialization is aimed at preparing Indonesian manufacturers of medical devices for the implementation of the ASEAN Medical Devices Directive (AMDD) and preparing the infrastructure of the National Medical Device Quality Management System Certification Institute in the KAN scheme so that it will facilitate manufacturers in obtaining SNI ISO 13485 certification at a relatively affordable cost.