• 2020-02-13 06:12:14

Taiwan Food and Drug Administration(TFDA) is organizing an upcoming seminar in end of July (July 20th, 2018) in Taoyuan (Taiwan), and Qualtech has been invited to share our GCP experience in China. This seminar will discuss the GCP inspection of medical devices in various oversea countries and how to conduct a multicenter clinical trial in various countries.

• 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),

• 2020-02-13 06:08:28

This month’s updates include the"Revision of Regulations on the Supervision and Administration of Medical Devices", “the Principles of Clinical Trial Inspection”, “a New Catalogue of Medical Devices to Be Exempted from Clinical Trials” among others. All information you need to know has been put in a nutshell:

• 2020-02-13 06:05:20

• 2020-02-14 04:21:46

A research conducted by BMI Espicom showed that the scale of the global medical device market is expected to reach US$38.91 billion in 2019, of which Japan has the world’s second largest medical device market, second to United States. Global medical equipment manufacturers in addition to Europe and the United States well-known manufacturers (GE, Medtronic, Johnson & Johnson, etc.),

• 2020-02-14 04:21:05

At the end of April, the State Council of China has formally expressed its views on the development of the “Internet + medical health” program. The objective of this planning is to improve medical health management, in order to optimize service efficiency, reduce costs, and to meet the increasing domestic needs on medical health.

• 2020-02-14 04:20:17

China National Drug Administration (CNDA) has revised the special approval procedures for innovative medical devices issued in 2014 to respond to current state. Drafts of the revision were released in early May and is currently open for public comments. This revision will be expected to take effect on October 1, 2018.

• 2020-02-14 04:19:20

In accordance with the requirements set forth in the "Standards management of medical equipment" and the "Management standard for revision of medical equipment standard system," the CNDA has initiated the FY 2018 - The Revision Plan of the Medical Device Standards last May 15.

• 2020-02-14 04:18:38

At the end of May, the China National Drug Administration (CNDA) has issued the "Technical Guidance for Electronic Submission of Medical Device Registration (Trial) (Draft) " (hereinafter referred to as the "Guidance") and sought for public opinion.

• 2020-02-14 04:17:45

During the early week in May, the Hainan Government has issued a further notice for “the Supervision Regulation of Emergency Medical Devices in Hainan International Tourism Area”. This is applicable to medical devices that are urgently needed for clinical purposes (hereinafter referred to as "emergency devices").