• 2024-07-30 03:14:40

The Medical Device Authority (MDA) enforced the policy of medical devices imported from or exported to countries without diplomatic relations with Malaysia that are subject to trade restrictions. This policy was approved during the MDA Member Meeting No. 1/2024 and has been effective since April 26, 2024, under Circular Letter No. 1/2024.

• 2021-11-24 09:49:19

With the continuing pandemic, PFDA relaxes its regulation for the manufacture of medical oxygen and the expiry of the special certifications for imported COVID-19 test kits. However, certain conditions must be met to be eligible for these exemption or extension.

• 2021-03-22 06:57:43

Department of Medical Equipment and Constructions issued a written to provide instructions for registration of imported medical equipment product on February 9th, 2021.

• 2020-11-27 02:07:10

This announcement applies to all registrants of foreign Class II and Class III medical devices that have been registered in China, through foreign manufacturers established in China.

• 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).

• 2020-04-14 08:47:59

In order to promote high-quality medical device industry, China is looking for ways to encourage domestic manufacturers to adopt higher technology and introduce incentives for foreign manufacturers with investments by local establishments.

• 2020-02-21 07:28:40

VN MOH released the Decree 03/2020, to amend Decree 36 & 169, which is effective from Jan 1, 2020. Below are remarks relating to the imported Medical Device as below: Qualtech marks up the different place comparing to Decree 36 & 169.

• 2020-02-12 14:21:58

Last August, NMPA has issued a draft entitled “Measures for the Supervision and Administration of the Local Authorization Agent for Imported Medical Device” in order to ensure the safety and effectiveness thereof. The draft was also aimed at regulating the behavior of local authorized agents of imported medical devices.

• 2020-02-13 06:11:12

In order for clients to understand the key factors affecting the registration situation of medical devices in China in the last three years (2015-2017), Qualtech has provided an overview and analysis of the medical device registration data (as provided in the following sections of this article),