In an effort to achieve health security, it is necessary to increase access to safe, quality, and innovative medical devices in regional and international markets which need to be supported by regulatory harmonization at the global level.
As one of the efforts to support regulatory harmonization at the global level and build cooperation between countries and international organizations, Indonesia is a member of the Global Hamonization Working Party (GHWP) which is a forum for preparing harmonization of medical device requirements, procedures and standards in its member countries.
GHWP regularly holds annual meetings to discuss global regulatory developments, establish guidelines developed by each working group, and conduct capacity building to improve members' knowledge and skills.
In 2024, Indonesia has the opportunity to host the 27th Annual Meeting of GHWP Technical Committee (TC) Leaders organized through the Directorate General of Pharmaceuticals and Medical Devices of the Indonesian Ministry of Health at Pullman Hotel Bali on June 12 to 13, 2024.
Representatives of the Directorate General of Pharmaceuticals and Medical Devices of the Indonesian Ministry of Health also oversaw this meeting, Director of Pharmaceutical and Medical Device Resilience Roy Himawan, Director of Medical Device Production and Distribution Dede Mulyadi and Director of Medical Device Control Eka Purnamasari.
In this meeting, Deputy Minister of Health Prof. Dante Saksono Harbuwono introduced the Balinese philosophy of "Tri Hita Karana" which simply translates as "three causes of well-being" or "three reasons for prosperity", where to get a happy life, life must be in harmony with God, in harmony with others, and in harmony with nature or the environment.
This philosophy is in line with the GHWP meeting where health thinkers and enthusiasts gather to exchange views on health in full, together envisioning a bright future in regulatory alignment, driving innovative development for global health.
Furthermore, the Deputy Minister of Health said that Indonesia is currently undergoing a major transformation in the health system, focusing on six key pillars, including the transformation of Primary Care, Referral Services, Health Security System, Health Financing System, Health Workforce Development, and Health Technology. These pillars represent the MoH's comprehensive approach to improving the accessibility, quality, and efficiency of health services across Indonesia.
”Saya ingin menekankan bahwa misi utama kami dalam GHWP adalah untuk mencapai konvergensi regulasi menuju praktik terbaik internasional di bidang alat kesehatan. Dengan menyelaraskan peraturan, kami dapat menyederhanakan proses persetujuan, mengurangi hambatan, dan memastikan bahwa kerangka kerja peraturan kami memenuhi standar global. Hal ini tidak hanya akan meningkatkan kualitas dan keamanan alat kesehatan, tetapi juga meningkatkan akses pasien terhadap produk- produk esensial ini,” ucap Wamankes.
Pertemuan ini diselengarakan agar alat kesehatan, alat kesehatan diagnostik invitro dan PKRT yang beredar di Indonesia memenuhi persyaratan keamanan, mutu dan manfaatnya ini dilakukan secara back-to-back dengan beberapa agenda terdiri dari GHWP TC Leaders Meeting, Capacity Building dan One-on-One Business Matching.
GHWP TC LeadersMeeting dilaksanakan dengan update dari masing-masing working group danclose door meeting yang diadakan secara terbatas, sedangkan Capacity Building yang diselenggarakan mengangkat tema Excellence In Medical Device Regulation And Innovation, terbagi menjadi Capacity Building untuk Regulator dan Industri alat kesehatan yang dilaksanakan secara bersamaan.
In addition, the One-on-One Business Matching activity brought together the medical device industry and medical device users to introduce domestic medical device products, in order to increase the use and awareness of domestic medical devices by health facilities. Participants of this business matching activity consisted of the Health Office and Regional Hospitals in Bali Province and also domestic medical device providers.