• 2020-02-12 13:54:20

On December 7th 2018, TFDA has formally announced that Japanese manufacturers may take a QSD simplified route of application.

• 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 14:24:17

Just recently, a number of advisories concerning recalls of healthcare products were observed to increase. These advisories being referred to are a result of product recalls conducted in accordance with the guideline issued in mid of 2016.

• 2020-02-12 15:56:38

The National Medical Product Administration (hereinafter referred to as NMPA) has released a list of medical device industry standards covering the new and amended standards from August 7th. Notable standards included in this exhaustive list, among others, include "Electrical safety standards for medical electrical equipment",

• 2020-02-12 15:55:53

On August 29, a new notice from the department of drug registration has revealed that CFDA has changed to its official English name to ‘National Medical Product Administration (NMPA)’ which was also adopted by the medical device registration system. It can be seen that NMPA is already an officially recognized English name.

• 2020-02-13 05:54:53

With an aim to strictly adhere to the provisions set by the ASEAN Agreement on Medical Device Directive (AMDD), the PFDA has issued a 3rd draft on the Rules and Regulations for the Registration Application for In-Vitro Diagnostic (IVD) Medical Devices to be placed in the Philippine Market.

• 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.