Quality assurance and safety of medical devices have been mandated both at the global level by the Food and Drug Administration (FDA) and the World Health Organization (WHO) and nationally in Law Number 36 of 2009 concerning Health to protect the public from medical devices that do not meet the requirements and are very risky to health or safety.

Control of medical devices is carried out by pre-market and post-market supervision, including certification of medical device production and distribution facilities and product certification. Efforts to maintain the safety, quality and benefits of medical devices during the production and distribution of medical devices are carried out by certifying the quality management system of Good Medical Device Manufacturing Methods (CPAKB) and Good Medical Device Distribution Methods (CDAKB) for medical device manufacturers and distributors.

In line with the transformation of the health system, especially in increasing the resilience of the pharmaceutical and medical device sectors, increasing the production of domestic medical devices must be followed by the fulfillment of quality assurance, safety and benefits so that there are no doubts from users in their use and can compete at the global level.

To provide awareness for medical device manufacturers and distributors about the regulations for accelerating the certification of CPAKB and CDAKB quality management systems and to encourage the improvement of the quality of domestic medical device products, the Directorate of Medical Device Supervision in collaboration with the IndoHCF Foundation, ASPAKI and GAKESLAB held a Webinar on Medical Device Quality Policy and Certification. The webinar, which was held online on May 21, 2022, was attended by more than 500 participants, consisting of manufacturers and distributors of medical devices and observers of domestic medical devices.

The government has made various efforts to encourage the development of the medical device industry, including by ensuring the needs of health care facilities for medical devices, increasing the use of domestic medical devices and utilization of research results, facilitating business licensing and accelerating quality management certification, improving the supporting ecosystem of the medical device industry, providing incentives and disincentives for the development of the medical device industry, and integrating integrated information systems. By improving the quality of medical devices, it is hoped that the Indonesian medical device industry will not only become a player in the country but also be able to contribute to the international arena.