• 2020-08-11 05:46:22

The Indonesian Ministry of Health has issued a guidebook, which will be explained the flow of medical device services specifically for medical and household health supplies used for handling Covid-19.

• 2020-06-16 08:03:29

MDA has recently announced that it will no longer consider Notification of Special Access (Route A) applications to manage COVID-19 medical device shortage in the country.

• 2020-06-16 08:03:29

PFDA released updated guidelines for the importers and manufacturers of PPEs, ventilators, and respirators in relation to the COVID-19 situation.

• 2020-06-16 07:02:42

COVID-19 outbreak causes the need for medical devices to be in very high demand. Therefore, IAPI (Association of Indonesian Procurement Experts) together with PERSI (Association of Hospitals throughout Indonesia) has provided an emergency medical equipment information system to handle the procurement and donation throughout Indonesia.

• 2020-06-16 05:58:49

Ministry of Finance Decree ( PMK-34/PMK.04/2020) stated that import of goods for the purposes of handling the COVID-19-related medical products are granted with customs and / or excise and taxation facilities. Applicant could apply the exemption through INSW website (http://www.insw.go.id/). This policy is started from 17 April 2020 until further date set by The National Disaster Mitigation Agency (BNPB).

• 2020-06-16 05:04:48

Thailand is presently at the PHASE 3 transition, where businesses are reopening , Qualtech presents collection of the regulatory updates from ThaiFDA, in relation to COVID-19 kit outbreak.

• 2020-06-11 10:06:42

PFDA issues FDA Circular No. 2020-016 to remind public that online sale of approved COVID-19 test kits is prohibited. Furthermore, the kits are for medical professional use only. PFDA urges law enforcement as well as the public to be vigilant regarding COVID-19 test kits in the market.

• 2020-06-11 10:00:48

Health Sciences Authority (HSA) is informed to the increased demands for medical products relevant to COVID – 19. Various establishments have considered 3D printing (3 – DP) to address the issue of limited supply of medical products.

• 2020-06-11 09:53:23

Health Sciences Authority (HSA) strengthens surveillance on different selling platforms to monitor health products with misleading claims to prevent, treat or diagnose COVID-19.; Warnings Issued to Over 1,600 Individual Sellers and Companies. HSA also urges public to be vigilant to report these products.

• 2020-05-12 08:23:22

PFDA reminds the public to buy health products, including medical devices and supplies, only from online sellers with proper authorization/s. In a separate announcement, PFDA released a guidance for manufacturers of PPEs, ventilators and respirators during the COVID-19 pandemic.