Medical devices are commodities that are used in efforts to prevent and treat diseases so that safety, quality, and benefits are important things that must be maintained and ensured so that the intended use of these medical devices can be achieved.

At the premarket stage, medical devices must fulfill facility and product certifications, such as product clinical trials, approval of distribution and advertising licenses, distribution licenses, and certification of Good Manufacturing Practices (GMP).

Post-market supervision is carried out through CDAKB certification audits, inspection of production and distribution facilities for medical devices and PKRT, sampling and testing, advertising supervision, marking supervision, and post-border supervision.

The Good Manufacturing Practice of Medical Devices (CPAKB) and its certification obligations for medical device manufacturers have been contained in Permenkes Number 20 of 2017 concerning CPAKB and CPPKRTB. Meanwhile, Government Regulation Number 5 of 2021 concerning the Implementation of Risk-Based Business Licensing has stipulated that CPAKB is one of the obligations that must be fulfilled by Business Actors in carrying out their business.

The provisions of CPAKB are further regulated in Permenkes No. 14 of 2021 concerning Business Activity and Product Standards in the Implementation of Risk-Based Licensing in the Health Sector which contains business standards for medical equipment manufacturers as well as the CPAKB certification process.

In order to increase awareness and understanding of medical device manufacturers to implement the CPAKB quality management system, the Directorate General of Pharmaceuticals and Medical Devices through the Directorate of Medical Device Supervision carried out Medical Device Production Center Development activities on July 04, 2022 at Artotel TS Suites Surabaya, East Java.

This activity was attended by 35 medical device manufacturers that have not been certified or are about to expire their CPAKB certificates in Surabaya, Gresik and Sidoarjo.

Acting. Director of Medical Device Supervision, Heru Sunaryo in his remarks when opening the event officially said, to be able to encourage compliance of medical device production business actors in fulfilling business obligations and strengthen supervision of safety assurance, quality, and benefits of medical devices that will later be used by the public, it is necessary to provide continuous guidance to medical device manufacturers so that they can implement the CPAKB quality management system consistently and are proven by having a CPAKB Certificate.

“In addition to the company's commitment to the implementation of CPAKB, one of the requirements that is the focus in medical device production facilities is the existence and participation of the Technical Person in Charge (PJT) who has an educational background according to laws and regulations, to be able to actively oversee the consistent implementation of CPAKB in the company,” Heru said.

It is hoped that this activity can increase awareness and understanding of medical device manufacturers in the East Java Region to implement the CPAKB quality management system.