• 2023-02-23 02:05:29

In order to supervise medical device registrants taking the responsibilities for medical device quality and safety, NMPA has issued the so-called "Regulations on Enterprises Implementing the Supervision and Management of Responsibilities for Medical Device Quality and Safety".

• 2023-02-23 02:02:05

According to the MDR and the IVDR, notified bodies shall make their standard fees public. In this guidance, the MDCG clarifies the requirements of the list of standard fees and provides the corresponding templates.

• 2023-02-23 01:59:23

The statistics as of January 2023 regarding the coverage of designation codes by MDR/IVDR notified bodies has been published in the attachment.

• 2023-02-23 01:45:57

A pilot run for new requirements on the procurement of medical devices by the Department of Health (DH) will be implemented with effect from 1st October 2022. Under the pilot run, medical devices purchased by Department of Health should preferably be listed under MDACS.

• 2023-02-23 01:39:29

The Procurement Bureau of the Ministry of Health and the National Public Procurement Agency plan to expand E-purchasing access for private health facilities participating as National Health Insurance (in Indonesia known as JKN) providers for transactions of medical devices in the e-katalog starting from January 2023.

• 2023-02-23 01:35:01

The Medical Device Authority (MDA) published the First Edition Guideline Document “How To Submit An Application For Registration Of A Refurbished Medical Device” (MDA/GL/10) on January 11, 2023. The MDA created this guidance document to assist the industry and healthcare professionals in their efforts to comply with the Medical Device Act (Act 737) and its regulations.

• 2023-02-23 01:28:49

A consultation window for framework and implementation of the Cybersecurity Labelling Scheme for Medical Devices [CLS(MD)] was announced to be open for the public from January 23 to March 3, 2023.

• 2022-09-27 07:35:39

In 2000, Qualtech was established in Taipei. Since then, Qualtech has established several locations around the world. Over the years, Qualtech has always insisted on providing high-quality medical equipment services such as regulatory consultation, product registration, clinical design and implementation, local authorized registration, and post-market surveillance. In addition to providing professional services, we also do not forget the social responsibility that belongs to Qualtech. Since Qualtech is engaged in the medical-related industry, we focus more on helping and caring for underprivileged groups.

• 2023-02-23 01:23:58

Thai FDA has published a guidance, which aims to assist the justification status of Software as Medical Device (SaMD) as well as its risk classification for Thai FDA registration.

• 2023-02-22 11:03:38

According to US FDA's review request for devices, the digital therapy device to reduce sleep disturbance for psychiatric conditions, and the prognostic tests for assessment of liver-related disease progression, will require special control (Class II). Thus, in the future, the US FDA will refer to the class II level to review these two kinds of devices.