• 2021-09-06 06:11:51

Qualtech Consulting would like to invite you to our free online Webinar on the subject of "Japan Medical Device Registration". Our event is scheduled to be held on September 17th (Friday), 2021.

• 2021-08-26 13:03:08

One similar thing about the medical device registration process in Taiwan and Japan is the documentation of the Quality Management System that must be registered with the local regulatory authorities before a medical device can be sold in each market. In 2021, there were major revisions made to the process of QMS documentation of which foreign manufacturers and local authorized representatives should be aware. This article will introduce those major revisions, as well as major differences in the QMS registration processes in Taiwan and Japan.

• 2021-08-26 12:58:20

In July, MOH released two Official Dispatches as guidance on registration routes and document preparation to import SARS-CoV-2 IVD medical devices and biologicals, especially SASR-CoV-2 Antigen Rapid Test Kit (RTK).

• 2021-08-26 12:02:05

In light of the latest COVID-19 situation in Malaysia, MDA has published a guidance document on medical face masks and respirators. The MDA/GD/0033 explains the minimum requirements for labeling as well as the performance characteristics of face masks and respirators that need to fulfill.

• 2021-08-26 11:43:03

Indonesia’s Ministry of Health has introduced simplified routes for certain class A medical devices. The characteristics of certain class A medical devices themselves are Home Use, Non-Sterile, and non-IVD. The products which can be registered through a simplified route will need fewer documentation requirements compared to the regular registration route.

• 2021-08-01 15:52:06

The Australian medical device market is mature, with a well-formed regulatory system. With 80% of its medical devices being imported and huge emphasis placed on smart medical devices, let's take a look at this robust market and its regulatory system, in this article.

• 2021-08-02 06:20:55

Consistent with the new guidance published in February 2021 governing the risk- classification, technical documentation requirements, fee schedule and transition plan for medical device registration, respectively announced for medical device manufacturing and importation exemption for certain medical under Medical Device Act 2008 Section 27 (1). The announcement aims to balance medical device distribution brought about by the significant changes in regulation.

• 2021-08-01 15:44:44

CMDE has added one more step to confirm the information shown on the medical device registration certificate and its attachments in the process of technical review from June 7, 2021.

• 2021-08-01 15:11:37

Recently, NMPA issued has issued a draft Regulation on self-testing for medical device registration. It has been published for public comments.

• 2021-06-25 08:59:13

Qualtech Consulting would like to invite you to our free online Webinar on the subject of the ”China Medical Device Registration – New Regulation for Supervision and Administration of MDs (RSAMD)”, which has gone into effect on June 1, 2021.