• 2020-02-15 09:11:10

Friendly interface and specific information could make you much more easily to know Qualtech and latest regulatory around the Asian countries.

• 2020-02-15 08:22:55

In order to provide customers with more complete medical device regulatory services in the Asian region, Qualtech establishs service presence in Malaysia.

• 2020-02-21 07:16:25

In order to maintain the safety and efficacy of a medical device, a surveillance system is needed. Therefore, medical device distributors in Indonesia are recommended to comply with CDAKB / Good Distribution Practice of Medical Device.

• 2020-02-21 07:15:43

As implemented starting from July 9th 2018, the Indonesian Government keeps developing the OSS system to actualize the acceleration of licensing process in Indonesia.

• 2020-02-21 07:14:51

Health spending is growing faster than the overall economy globally as well as in most countries. In this article, we are looking at the healthcare expenditure and medical device demand trends in China, Thailand, Malaysia and Singapore, to understand how their government are spending to improve the living standard of their citizens.

• 2020-02-21 07:12:37

On December 20, 2019, the NMPA issued an update of the Exemption List from Clinical Trials in China for Medical Device (hereinafter simply referred to as the “Exemption list"), which includes "medical devices" and "in vitro diagnostic devices".

• 2020-02-21 07:11:54

After publishing the guidance of clinical evaluation in the International Medical Device Regulators Forum (IMDRF), the NMPA has quickly released the revised guidance of clinical evaluation for China registration. This guidance is predicted to be implemented by 2021.

• 2020-02-21 07:11:04

On December 20, 2019, the NMPA has issued the so-called "Guidelines for Conditional Approval of Medical Devices " . The Guideline was officially implemented on the day of release and will help expedite the conditional approval of medical devices under certain circumstances.

• 2020-02-21 07:10:23

On December 25, 2019, the NMPA issued the so-called "Guideline for General Naming Rules for Medical Devices" (hereafter simply referred to as the “Guideline”), which is based on the "Medical Device Common Name Naming Rules". The Guideline is formally implemented from now on, and is applicable to medical devices only, not including IVDs.

• 2020-02-21 07:09:30

The Taiwan Council passed the draft of the " Regulations of Medical Devices" (hereafter simply referred to as the “Regulation”) in December 2019. The regulation has medical devices to be legislated independently and thus no longer fall under the Pharmaceutical Affairs Act.