Medical devices are one of the important components used to diagnose, prevent, monitor, treat or alleviate disease, as well as to correct injuries or support life for people with disabilities. Meanwhile, Household Health Supplies (PKRT) are tools, materials or mixtures of materials for the maintenance and treatment of human health, which are intended for use in households and public facilities. Therefore, medical devices and PKRT must be useful, of good quality, and safe when used, so they must be properly produced and distributed according to standards and regulations to remain qualified, precise and safe.

Quality assurance and safety of medical devices have been mandated globally by the world institutions Food and Drug Administration (FDA) and World Health Organization (WHO) through the obligation to implement the production and distribution of medical devices according to standards, as well as regulations in Indonesia mandated in Law Number 36 of 2009 concerning Health, so that it must be ensured that medical devices circulating and used are those that have met the quality and safety requirements and their benefits. This can be done by the government through guidance and supervision of production and distribution facilities for medical devices and PKRT, as well as premarket and postmarket supervision of medical devices and PKRT products circulating in the community. Such supervision is very important to protect the public from medical devices and PKRT that do not meet the requirements, which are very risky to health and safety.

With the issuance of Government Regulation Number 5 of 2021 concerning the Implementation of Risk-Based Business Licensing and Regulation of the Minister of Health of the Republic of Indonesia Number 14 of 2021 concerning Business Activity and Product Standards in the Implementation of Risk-Based Business Licensing in the Health Sector, business licensing is held centrally through the OSS RBA system with ease of licensing process and standardization of regulations related to facilities and products in all regions of Indonesia. There are several changes from regulations that affect changes in licensing implementation, including:

• The Ministry/Agency in charge of the medical device/PKRT industry is transferred to the Ministry of Industry (through a circular letter from the Coordinating Secretary for Economic Affairs Number PI.01/433/SES.M.EKON/06/2021), so that business licensing is carried out in accordance with the NSPK issued by the Ministry of Industry;
• The Ministry of Health as a Supporting Ministry / Institution for the medical device and PKRT industry is authorized to provide business licenses to support business activities (PB UMKU) such as CPAKB, CPPKRTB, distribution permits, Certificate of Free Sale (CFS) and so on.

The Directorate General of Pharmaceuticals and Health through the Directorate of Supervision of Medical Devices and PKRT carried out the Socialization of Licensing and Supervision of Production and Distribution Facilities for Medical Devices and PKRT on January 13, 2022 to increase the knowledge and understanding of business actors about regulatory changes and implementation adjustments. The activity was carried out online with approximately 1000 business actors in the field of production and distribution of medical devices and PKRT, officially opened by the Director General of Pharmaceuticals and Health Equipment, Rizka Andalucia. In his remarks, the Director General said “Business actors in the production and distribution of medical devices must realize the importance of compliance with regulations because it can have an impact on the safety, quality and benefits of medical devices and PKRT that are produced and distributed to administrative sanctions in the form of warnings to revocation of business licenses, termination of advertising, withdrawal and destruction of products”.