The Technical Responsible Person (PJT) plays a crucial role in the distribution of medical devices, particularly concerning the application for the Distribution License for Medical Devices (IDAK). This position is essential for ensuring product quality before distribution, enforcing health regulations within the company, and serving as a liaison between the company and the Ministry of Health.

When applying for a new IDAK or making changes due to a PJT transition, a formal agreement must be established between the PJT and the company. This agreement, certified by a local notary, validates its authenticity through a process known as 'Waarmerking.' However, a recent announcement letter from the Ministry of Health (No.FR.03.06/E.V/1905/2024) indicates that effective January 1, 2025, this agreement must be formalized through a notarial deed (Notarial Deed of Cooperation Agreement between PJT and the Company), in accordance with regulation PMK 14/2021.

The implementation of this new regulation will be communicated through socialization efforts from October 1 to December 31, 2024, via the Regalkes system. This proactive approach aims to ensure a smooth transition and compliance with the updated legal framework, emphasizing the importance of the PJT in maintaining the integrity and safety of medical devices in the market.

Please contact us for further details, updates, and queries related to IDAK certification and PJT agreement.

Source : Surat Pemberitahuan Nomor FR.03.06/E.V/1905/2024