• 2020-07-31 10:40:17

ThaiFDA is highly concerned with the health and the well-being of the people abrupt from the situation of PM.2.5 in Thailand. Respectively, the “Letter of Notification: Registration of Importer Establishment License and Registration of Medical Mask for Special Circumstance” was announced.

• 2020-05-06 06:04:19

Thai FDA is highly concerned with the health and the well-being of the people abrupt from the situation of PM.2.5 in Thailand. Respectively, the “Letter of Notification: Registration of Importer Establishment License and Registration of Medical Mask for Special Circumstance” was announced.

• 2020-05-06 05:10:35

In a recently issued revised guideline on How to Apply for Medical Device Registration Under Medical Device Act 2012 (Act 737), MDA specified that it can drop an ongoing application from MeDC@St system if it exceeds a 90 days stop-clock-time and any new applications which do not conform to requirements specified will be rejected, non-refundable.

• 2020-05-05 07:31:28

Registration of both local and foreign-manufactured medical devices in Malaysia is generally a two-part process. They are mainly regulated by the Medical Device Authority (MDA) of Malaysia, a local regulation and authorization body.

• 2020-05-05 07:53:33

HSA introduced evaluation routes to hasten the registration of high-risk devices. GN-15 contains the details of each routes. The latest update for GN-15 (version 7.2) improves the criteria for class B devices to undergo Immediate Class B Registration (IBR) Evaluation Route.

• 2020-05-05 06:46:09

NMPA releases the registration approval power to other NMPA branch to enhance the foreign medical device access to China market. This action brings more opportunities for the foreign manufacturers to get product license and enter China market.

• 2020-02-12 14:15:38

Based on the provisions stated in Republic of Indonesia Minister of Health Regulation no. 62 year 2017 and the socialization of procedures for classification of Medical Devices and PKRT, MoH announced the enactment of class determination and the making of billing codes independently by the applicant.

• 2020-02-12 14:13:36

The PFDA Chief has recently reported that the agency has already reduced around 3,500 backlogs out of 80,000 pending applications, including those that were carried over from previous administrations. It was also estimated that this number will be further reduced by 1,400 following the verification and posting of these applications.

• 2020-02-12 14:11:38

In order to encourage the development of medical devices intended for rare diseases, CNMPA has drafted a guideline whose key principles where founded on the “Opinions on Deepening the Reform of Examination and Approval System Reform and Encouraging Innovation of Pharmaceutical Medical Devices”  published by the General Office of the State Council.

• 2020-02-12 14:08:37

Medical device regulations in China have changed frequently in the recent years. With its 10-year experience in the registration of non-active medical device in China, Qualtech would like to share an overview of the common roadblocks of the registration process a foreign manufacturer frequently encounters.