• 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.

• 2020-02-12 14:18:59

In carrying out the medical device registration process in Indonesia the applicant must fulfill administrative and technical documents requirements.

• 2020-02-12 15:54:36

In carrying out the medical device registration process in Indonesia the applicant must fulfill administrative and technical documents requirements. Indonesia MOH had a seminar to describe how to prepare the submission document. Qualtech summarizes as this article.

• 2020-02-13 06:04:14

In connection with the stipulation of Government Regulation No. 24 of 2018 on Electronic Integrated Licensing Service or commonly named as OSS (Online Single Submission), the Ministry of Health of R.O.Indonesia stipulates Republic of Indonesia Ministry Regulation number 26 of 2018,

• 2020-02-14 03:49:35

In the other word, a marketing authorization license of medical devices containing mercury that has an expiry date later than December 31, 2018 will be automatically not valid after that date and the owner of a marketing authorization license must surrender the marketing authorization back to the Ministry of Health of Indonesia cq.

• 2020-02-14 04:14:45

Devices classification in Indonesia has followed ASEAN AMDD, which has been aligned to PERMENKES UU NO.62 years 2017. Medical Device classified into 4 risk classes (A,B,C,D based on level of risk)