• 2020-02-12 13:57:05

Obtaining market access in the Japanese medical device market may sometimes represent a bit of a challenge for foreign manufacturers, we can provide interested customers with the full spectrum of services required for a smooth access to the Japanese market.

• 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 14:15:38

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 14:14:35

Japan Association of Medical Device Industry (JAMDI), DEKRA Japan, and Qualtech Japan will jointly held an upcoming seminar on 21st December, 2018 at Dawn Center Osaka, Japan.

• 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 14:12:33

MDCO has created and developed a Web-based In Vitro Diagnostic Medical Device Classification Program, where previously only the classification program for General Medical Device was available. This is to facilitate the classification of the In Vitro Diagnostic Medical Device according to its risk level under the Medical Device Administrative Control System.

• 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 14:09:42

China National Medical Product Administration (NMPA) has revised the special approval procedures for innovative medical devices issued in 2014 to respond to current state. This revision will be effective on December 1, 2018.

• 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.

• 2020-02-12 14:25:26

At the end of September 2018, Medical Device Authority (MDA) had introduced two search engines/databases for the public-use. On a first glance, they look similar to the medical device database of Singapore HSA’s Singapore Medical Device Register (SMDR) but the working mechanism and output are different.