• 2022-09-27 08:23:11

A pilot run for the new requirement on the procurement of medical devices by the Department of Health will be implemented with effect from 1st October 2022. Under the pilot run, medical devices purchased by the Department of Health should preferably be listed under MDACS.

• 2022-09-27 07:58:07

Effective since 6th July 2022, Indonesia’s Ministry of Health has issued Ministry of Health Decree number HK.01.07/MENKES/1258/2022 concerning Substitution of Imported Medical Devices with Domestic Medical Devices in the Electronic Catalog / e-Katalog of the Health Sector that implement the freeze/ unfreeze mechanisms.

• 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.

• 2022-05-26 13:08:24

NMPA, in conjunction with the National Health Commission, has revised the Quality Management Practice for Clinical Trials of Medical Devices, which is hereby promulgated and will take effect from May 1,2022.
Attachment: Quality Management Practice for Clinical Trials of Medical Devices

• 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.

• 2022-01-26 10:55:53

The Health Sciences Authority (HSA) has published an update on the Regulatory Fees for Health Products. This is to ensure that the evaluated products meet the required standards of quality safety and efficacy. It is also necessary to recover part of the costs for the services rendered to businesses.

• 2021-10-27 07:19:29

More than 100 administrative procedures under management of the Ministry of Health have been reduced and simplified with a recently introduced regulation. One of these is to convert Import Permit number to Registration number and to amend requirement on application for fast approval from 2 CFS to 1 CFS.

• 2021-03-29 01:45:09

Due to Qualtech’s vast experience in the ASEAN regulatory field, Qualtech’s specialists have been cordially invited to speak on the medical device registration processes in Vietnam, Indonesia, and the Philippines at the ASEAN Healthcare Market Conference.

• 2020-12-24 01:44:02

Ministry of Public Health has announced that direct advertising to medical and public health practitioner are exempted from applying for advertising license,  for the convenience in advertising medical devices.