Ensuring the safety, quality, and benefits of medical devices is carried out by keeping each cycle of medical devices running properly, one of which is by strengthening the supervision of medical devices and PKRT as well as standardizing production and distribution facilities through CPAKB, CPPKRTB, and CDAKB certifications for production and distribution facilities for Alkes and PKRT.

In addition, 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, this is also in line with regulations in Indonesia stated in Law Number 36 of 2009 concerning Health, so it must be ensured that medical devices circulating and used are those that have met the quality, safety and benefits requirements.

To fulfill this mandate, the Directorate General of Pharmaceuticals and Medical Devices through the Directorate of Medical Device Supervision held a Medical Device Industry Advocacy activity in the context of CPAKB Certification offline on July 21-22, 2022 at Dafam Hotel Pekalongan, Central Java and was attended by 35 medical device companies.

The Head of the Certification and Supervision of Production Facilities Working Team, Ismiyati, in her remarks when opening the event officially said that this activity aims to provide advocacy to business actors so that in carrying out their business they have followed the provisions of the Good Manufacturing Method of Medical Devices.

In this activity, guidance is provided to medical device production centers in order to implement a quality management system consistently by verifying CPAKB certification application documents and self-assessment documents by medical device companies that have submitted applications.

In addition to verifying CPAKB documents and self-assessment documents, this activity also conducted socialization of the Mobile Alkes application. Mobile Alkes is an Android-based application that is useful to facilitate supervisory personnel and the public in checking the NIE (Edar License Number) of medical devices and PKRT, as a means to report complaints about medical devices and PKRT products including to report advertisements for medical devices and PKRT that are not in accordance with statutory provisions.