• 2020-03-16 06:38:53

Ministry of Health has issued a Circular letter number HK.02.02 / VI / 1465/2019 about withdrawal and elimination of medical devices that contain mercury from the market. This circular letter is addressed to Head of medical devices manufacturer and Head of medical device distributor in throughout Indonesia. They need to take several actions to help the withdrawal and elimination process of medical devices that contain mercury.

• 2020-03-16 06:34:36

In accordance with applicable regulations of MOH Indonesia, medical devices must go through an assessment process by the MOH Indonesia to obtain a marketing authorization number. This marketing authorization number means that the medical devices have been declared safe and efficacy.

• 2020-02-21 07:16:25

In order to maintain the safety and efficacy of a medical device, a surveillance system is needed. Therefore, medical device distributors in Indonesia are recommended to comply with CDAKB / Good Distribution Practice of Medical Device.

• 2020-02-21 07:15:43

As implemented starting from July 9th 2018, the Indonesian Government keeps developing the OSS system to actualize the acceleration of licensing process in Indonesia.

• 2020-02-21 06:56:04

In Indonesia, E-Katalog become the most popular platform for the public hospital or government related institution to find required medical device equipment. In October, Government invite Medical Device Company to submit an offering of Medical Devices and Household Health Supplies products to be included in E-Katalog.

• 2020-02-21 06:54:34

Changing some information after device approved can be done through amendment which has shorter timeline for approval. However, not all of the changes in the device can apply for amendment. Indonesia Ministry of Health elaborate specific criteria for the type of changes that can be reported as amendment to MoH.

• 2020-05-06 09:11:58

MOH established a Medical Device Risk Classification System on the MOH website called SIKLARA. This system aims to facilitate applicants in classifying medical devices and minimalize errors in class determination. However, this system is only available in Indonesian.

• 2020-05-05 06:04:25

Regarding the implementation of the Digital Signature system which began on 14 February 2019, the Indonesian Ministry of Health determines the format of Labelling Material Design documents uploaded for product registration .

• 2020-02-12 14:03:26

Starting January 2019, Medical Device Marketing Authorization License will be issued in electronic form. This is in accordance to PMK No. 62 year of 2017 Article 22, which stated that Marketing Authorization License will not require stamp and wet signature anymore.

• 2020-02-12 14:15:38

Based on the provisions stated in Republic of Indonesia Minister of Health Regulation no. 62 year 2017 and the socialization of procedures for classification of Medical Devices and PKRT, MoH announced the enactment of class determination and the making of billing codes independently by the applicant.