• 2022-07-26 11:10:17

The National Public Procurement Agency, which is responsible for managing the government e-Katalog, issued provision No 122/2022 concerning Procedures for Organizing Electronic Catalogues. This changed previous e-Katalog mechanisms includes the MoH Sectoral E-Katalog.

• 2022-05-26 13:40:37

The National Public Procurement Agency, which is responsible for managing the government's “e-Katalog”, issued provision No. 122/2022 concerning the Procedures for Organizing Electronic Catalogues. This changed the previous “e-Katalog” mechanisms including MoH's Sectoral E-Katalog.

• 2022-03-25 10:41:47

Indonesia's MoH has announced the integration of their licensing system: REGALKES with OSS RBA (Online Single Submission Risk-Based Approach) for new applications of marketing permit and their plans on integrating more licensing services with OSS RBA.

• 2022-03-25 10:38:56

Starting from February 2022, the Indonesia Ministry of Health is accepting product listing of medical devices and other health equipment for their sectoral e-catalogue for health facilities.

• 2022-02-18 08:22:55

Indonesia MoH has officially implemented a notification scheme for certain class A medical devices in the REGALKES system since 10th January 2022.

• 2021-11-24 03:09:42

MOH has recently released new Decree that is intended to unify all regulations on Medical Device Management and implemented from next year.

• 2021-08-26 12:58:20

In July, MOH released two Official Dispatches as guidance on registration routes and document preparation to import SARS-CoV-2 IVD medical devices and biologicals, especially SASR-CoV-2 Antigen Rapid Test Kit (RTK).

• 2021-06-25 12:51:04

The guidance, released as Decision No. 2426/QĐ-BYT, was constructed according to AMDD and with reference to the guidance of Singapore and Malaysia, and applicable to medical devices Class B, C, D including in-vitro diagnostic IVD MD.

• 2020-02-21 06:54:34

在設備批准後更改某些信息可以通過修正來完成，因為修正的時間表較短。 但是，並非設備中的所有更改都可以申請修改。 印度尼西亞衛生部為可作為衛生部修正案報告的變化類型製定了具體標準。

• 2020-02-12 09:09:07

越南衛生部發布了第169/2018 / ND-CP號法令，對第36號法令中有關醫療器材管理的某些條款進行了補充，並自簽署之日起生效。