• 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 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 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.

• 2021-05-22 06:49:37

Recently, NMPA issued a Notice on Registration of Medical Device Technical Dossier (No. 36 of 2021), which will facilitate medical device manufacturers to choose raw materials and key components, simplify registration declaration, improve the quality of medical device review and approval, establish a more scientific and efficient review and approval system, and encourage innovation.

• 2021-03-22 06:21:15

After seeking for public and specialist opinions for a while. Finally, Thai FDA has announced the official-related announcements regarding a transition from policy-based classification to risk-based classification of medical devices.