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Indonesia MoH, Announces Requirements for E-Katalog System Regarding Application of Medical Device GDP Certificate

JNM Global 제이엔엠글로벌 2024. 10. 23. 10:00

 

The Ministry of Health (MoH) of Republic of Indonesia issued circular no. HK.02.02/E/1753/2024 on September 9, 2024, to implement the Good Distribution Practice (GDP) certification as a requirement for the electronic catalog system, ensuring the safety, quality, and performance of medical devices.

According to Government Regulation No. 28 of 2024 (implementing Law No. 17 of 2023 on Health), the key points are as follows:

  1. All medical device distributors must obtain a Good Distribution Practice (GDP) certification for medical devices.
  2. From January 1, 2025, the GDP certificate for medical devices will be a mandatory requirement for listing products in the electronic catalog (e-Katalog).

Please refer to attached document below. 

178.pdf
0.14MB

 


 

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