Sealing of production and distribution facilities of medical devices and PKRT that do not have business licenses in Banten and West Java provinces on September 28-30, 2022.The ease of licensing through OSS RBA has an impact on the increase in the number of manufacturers and distributors of medical devices and Household Health Supplies (PKRT) that need to ensure compliance with regulations. Trust but Verify is a mandate that is held, where under these conditions supervision activities of products and facilities for the production and distribution of medical devices and PKRT must be optimized. Based on Law number 36 of 2009 concerning Health, it is stated that the state guarantees that medical devices and PKRT in circulation meet safety standards, are of good quality and are useful for use and increase health security, are environmentally friendly and affordable.
The Directorate of Medical Device Supervision as the holder of the main tasks and functions of enforcing laws and regulations in the field of medical devices and PKRT conducted incidental supervision activities in the form of inspections of production and distribution facilities for medical devices and PKRT in the Banten and West Java provinces on September 28-30, 2022. This inspection was carried out as a follow-up to public reports/complaints submitted through the mobile application of medical devices and through the submission of letters.
Mobile Alkes is an application to facilitate the public to obtain information about medical devices and to report/complain about complaints/violations of medical devices and household health supplies. The results of the implementation of this incidental inspection found PKRT products that do not meet the requirements of the legislation. Based on these findings, the supervisory staff took product safety measures to be able to take further action.
In addition to the implementation of incidental inspections, the Directorate of Medical Device Supervision also supervises licensing compliance. This is a follow-up to the report of the West Java Provincial Health Office. As a result of the implementation, the team secured facilities that did not have a business license.
As a follow-up to the results of supervision of facilities that have been carried out previously, in order to ensure the safety, quality and benefits of medical devices and PKRT circulating in Indonesia, guidance is carried out for facilities to be able to comply with applicable licensing regulations and for products that do not have distribution permits have been destroyed.
