Safeguarding pharmaceutical preparations and medical devices is one of the efforts in health development carried out to protect the public from hazards caused by the use of pharmaceutical preparations and medical devices that are not appropriate and that do not meet quality, safety and usefulness requirements.

The Directorate General of Pharmaceuticals and Medical Devices through the Directorate of Medical Device Control has a contribution in ensuring that medical devices and PKRT in circulation meet the standards or requirements for safety, quality and benefits through post-market supervision of medical devices and PKRT.

Accredited medical device and PKRT testing laboratories are needed to support the implementation of post-market surveillance. However, the availability of accredited medical device and PKRT testing laboratories in Indonesia is still very limited both in terms of number and testing capabilities.

In order to strengthen the capacity of medical device and PKRT testing laboratories, the Directorate of Medical Device Control carried out HR Capacity Building activities in Strengthening Medical Device and PKRT Testing Laboratories offline at Swiss Bell Hotel Bogor from July 12 to 15, 2022.

This activity was officially opened by Acting. Director of Medical Device Control, Heru Sunaryo, and was attended by 21 participants representing laboratories related to medical device and PKRT testing.

In his remarks, Acting. Director of Medical Device Control said, with a stronger testing laboratory, it is hoped that it can support efforts to guarantee medical device and PKRT products in circulation so that the public is protected from unqualified products that pose a risk to health and safety.

Present in this activity were speakers from the Directorate of Systems and Accreditation Harmonization of BSN who delivered SNI ISO / IEC 17025: 2017 material related to general requirements for the competence of testing laboratories and calibration laboratories including the scope of testing, internal and external quality assurance, quality documentation, internal audits and management reviews and SNI ISO 17025 accreditation requirements.

"I hope this meeting can be a means for introducing, understanding and increasing the competence of human resources to fulfill the requirements of the SNI ISO / IEC 17025 standard: 2017 General requirements for the competence of testing laboratories and calibration laboratories," Heru said.