• 2020-02-15 08:26:12

The initial meeting for pilot-clinical trial of AHSONG Colonic Irrigation Apparatus, held on Nov 7th, 2013, in Mackay Memorial Hospital.

• 2020-02-15 08:23:38

On Nov 19th, 2013, the investigator meeting was held to start the clinical trial of Dermal Filler, a class III medical device, for CFDA registration purpose

• 2020-02-15 09:10:35

Qualtech TFDA manager is invited to be the speaker in Singapore seminar "Understanding Taiwan's Regulatory Framework for Medical Devices" organized by Singapore Manufacturing Federation and DH RegSys Pte Ltd.

• 2020-02-15 08:52:37

Qualtech was invited by OMETA (Overseas Medical Eauipment Tech. Assistants) to give the speech of regulatory registration in Taiwan and China.

• 2020-02-15 08:44:50

On 25 June & 26 June, 2013, Qualtech TFDA manager, Juliana Chang, was invited by  Singapore Manufacturing Federation and DH RegSys Pte Ltd to give the TFDA training in Singapore.

• 2020-02-15 09:00:48

The successful forum had been held on April 15th, 2013 at Taipei.

• 2020-02-15 09:12:24

 Our Singapore Office is Open.

• 2020-02-15 09:11:48

Qualtech had successfully got second CFDA approval license of Class III implant product in the end of December, 2012. 

• 2024-06-19 09:35:10

The rise of connected medical devices has revolutionized healthcare, but it has also introduced new cybersecurity challenges. To address these concerns, Singapore has implemented the CLS(MD) scheme, a collaborative effort to enhance medical device cybersecurity.
This article explores the latest updates on the CLS(MD) Sandbox program, its background, key details, and how medical device manufacturers can benefit from participation.

• 2021-10-27 07:43:08

Every once in a while, Japanese Ministry of Health, Labor and Welfare (MHLW) issues notices to announce evaluation principles of “Next-Generation Medical Devices,” to accelerate review and approval process of new medical devices which has high demands and high feasibility of product realization. Since 2008, there have been 27 issuances by MHLW listed in the end of this article.

In this article, we will introduce list of “Next-Generation Medical Devices” that were announced in the past notices as well as were one of the notices issued in September of 2020, “Evaluation Index of Medical Devices for Home Medical Care”.