• 2020-02-14 03:52:53

China National Drug Administration (CNDA) (formerly known as CFDA) has issued a new policy for Hong Kong medical device manufacturers to enter Mainland China market. CNDA can now accept Certificate of Listing and Certificate to CNDA as marketing approval and Quality Management System certificates which are the necessary documents for medical device registration in China.

• 2020-02-13 06:15:29

All concerned Industry/Stakeholders were invited to attend the FDA Executive Presentation on New Fee Structure and Modernization scheduled last June 28-29 which was held at the Philippine International Convention Center, Pasay City. Based on the informal talks between Qualtech and PFDA,

• 2020-02-13 06:14:29

Following the Executive Presentation on the New Fee Structure and Modernization Initiatives held last June 28-29, a draft of the New Schedule of fees has been posted which aims to notify all stakeholders concerning the significant increase in charges associated with medical registration,

• 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.

• 2020-08-06 09:09:52

• 2020-02-14 04:24:02

Thai FDA published an eye-related product classification checklist guide to help determine whether each product fall under the category of not medical device, medical device, drug, or cosmetic.

• 2020-02-14 04:23:23

TFDA Department of Medical Device and Cosmetics is set to move to a new office starting on April 30, 2018. The new office will be located at the Alley 12, 2nd Section of Yan Jiu Yuan Road, Nangang District, Taipei City.

• 2020-02-14 07:37:59

CFDA has released the draft of 3D-printed medical device guidance during the last week of February. The draft guidance provides the general requirements of registration rules on 3D printed medical device.

• 2020-02-14 07:36:53

The state council of China issued a cabinet report during the congressional sessions in March. China government plans to reform many agencies and establish a new administration, market supervision administration. The affected agencies include the State Administration of Industry & Commerce,

• 2020-02-14 07:34:46

Medical device regulations in China have changed frequently in the recent years, such as updating of multiple national standard andindustry standards, issuing of product guidance and administrative directives. With its 10-year experience in China's active medical device registration,