• 2020-02-21 07:25:15

Having witnessed the changing and rapidly developing landscape of many Southeast Asian countries and their medical device markets, Qualtech has outlined the most convincing factors and trends on why you should definitely consider expanding your business to the ASEAN markets.

• 2020-02-21 07:24:35

Qualtech’s Taipei Office was awarded with the Certificate of Excellence for its Good Distribution Practice in Taiwan by the TFDA.

• 2020-02-21 07:23:38

Qualtech assisted in all registration stages, which included our service of planning the product pre-market strategy, conducting type testing, clinical trials, GCP inspection, medical writing, and the registration itself.

• 2020-02-21 07:22:04

Earlier in January 2020, MDA had released a revised Circular Letter No. 2 Year 2018, on the control of orphaned, obsolete and discontinued medical device healthcare and related facilities. There have been some revisions introduced to the definition of types of medical devices covered in this circular letter.

• 2020-02-21 07:21:24

MDA has introduced new revisions to the Guidance Document on Import And/or Supply of Unregistered Medical Devices for The Purpose of Demonstration for Marketing or Education. All stakeholders are advised to take of these changes while making an application for the Notification of Medical Device for Demonstration purposes, to ensure a smooth process.

• 2020-02-21 07:20:48

The Ministry of Health (MoH) was recently notified by the MDA on a 'headphone' device that allegedly reduces and controls blood sugar levels, published through a local newspaper.

• 2020-02-21 07:19:49

CDSCO India has issued an extension for several types of medical devices to register for market authorization, some until January 2021 while the other types have until April 2021.

• 2020-02-21 07:19:00

Eight notified bodies have now been registered with the CDSCO intends to carry out audit of a manufacturing site of Class A or Class B of medical devices.

• 2020-02-21 07:17:09

HSA released a draft guidance for software regulation last December 2019. The draft includes detailed explanation of regulation from pre-marketing approval to post market monitoring of software devices. The Singaporean authority would like to ask for stakeholder comments before official implementation

• 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.