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Qualtech ANALYSIS: The Benefits of Assigning a Neutral 3rd Party as Your Local License Holder AND a Summary of the Product Registration License Conditions in ASEAN, East Asia, and Australia – February, 2022

Qualtech ANALYSIS: The Benefits of Assigning a Neutral 3rd Party as Your Local License Holder AND a Summary of the Product Registration License Conditions in ASEAN, East Asia, and Australia – February, 2022

  • 2022-02-18 07:20:17

As Qualtech offers Authorized Representative (License Holder) Services in 11 countries in Asia and Oceania, the following article outlines some of the benefits for foreign manufacturers associated with assigning a neutral 3rd party as their license holder. In addition, the product registration license conditions for the different ASEAN countries, as well as Taiwan, Japan, Hong Kong, Australia, and China are summarized, including license validity, license transfer possibilities etc.

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QT Analysis: 5 Pivotal Regulation Updates for Medical Devices that You Need to Know from PFDA – September 2021

QT Analysis: 5 Pivotal Regulation Updates for Medical Devices that You Need to Know from PFDA – September 2021

  • 2021-09-28 23:56:41

This year, the Philippine Food and Drug Administration (PFDA) has released key registration guidelines that will significantly impact prospective medical device importers/distributors. In this article, we will give you an overview that can serve as your roadmap to navigate these regulatory changes. Read through to know a few other important announcements from PFDA.

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QT Analysis: Registration of Quality Management System in Taiwan & Japan  - August 2021

QT Analysis: Registration of Quality Management System in Taiwan & Japan - August 2021

  • 2021-08-26 13:03:08

One similar thing about the medical device registration process in Taiwan and Japan is the documentation of the Quality Management System that must be registered with the local regulatory authorities before a medical device can be sold in each market. In 2021, there were major revisions made to the process of QMS documentation of which foreign manufacturers and local authorized representatives should be aware. This article will introduce those major revisions, as well as major differences in the QMS registration processes in Taiwan and Japan.

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QT ANALYSIS: Rehabilitation medical device market and registration requirements in Asia

QT ANALYSIS: Rehabilitation medical device market and registration requirements in Asia

  • 2021-02-19 09:51:48

Asia’s elderly population is set to see tremendous growth, coupled with a rise in various geriatric and non-communicable health issues. To tackle these problems, rehabilitative and assistive medical devices market show great potential to become a major medical device segment in various Asia countries. In this issue of QT Analysis, we look at the market size for rehabilitative and assistive medical device and their registration requirements in some major Asian countries.

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