• 2023-05-24 07:33:47

Qualtech's big topic article for this month's edition represents an overview of the recent and upcoming changes implemented in the ASEAN countries of Southeast Asia. We thereby cover 6 ASEAN countries and review the most critical and noteworthy changes, so that our readers remain up-to-date and can take required actions in a timeline manner.

• 2023-03-29 10:01:23

If you would like to know more about these aspects and many more important regulatory information for the ASEAN markets, you may join Qualtech's ASEAN Regulation Update Webinar on 28 April 2023 (Friday) at 16:00 p.m. – 17:30 p.m. (GMT+8).

• 2023-02-23 02:33:41

Qualtech, in cooperation with Mr. Arkan Zwick of Austrian Manufacturer Croma-Pharma GmbH, have organized a webinar on the important updates pertaining to the EU MDR on February 7, 2023. Topics discussed include the European Commission's Proposal to extend the MDR transition period as well as the validity of MDD certifications, and our suggestions regarding the critical steps to be taken in order to smoothly obtain approval under the MDR. The content of the webinar has been briefly summarized in this article.

• 2023-01-19 06:29:59

Qualtech's internal Southeast Asia regulatory training and our End of the Year Party 2022 have been successfully completed. As the borders have gradually reopened and travel restrictions have been lifted, Qualtech has invited its members from the various ASEAN countries as well as from Japan to gather in our headquarter in Taipei. The accomplishments of the gathering include the exchange of regulatory information, the fostering of better communication, and the strengthening of our teamwork across the various Qualtech branch offices.

• 2022-11-29 03:32:40

Qualtech introduced medical device regulations and the role of authorized representative in ASEAN in the seminar held by Tokyo University's association, which supports medical device innovation.

• 2022-10-25 03:47:11

The OMETA/Qualtech Webinar 2022 was held on September 29, featuring updates on regulations in Asia.

• 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.

• 2021-10-04 05:18:22

On September 17th, Qualtech hosted its Webinar on the subject of Japan Medical Device Registration to an international audience of MD manufacturers. During the event, the Qualtech team thoroughly explained the Japan registration process and elaborated on aspects such as registration timelines, product classifications, and consultation sessions with PMDA.

• 2021-08-02 06:36:08

On June 30th, Qualtech and ISS AG jointly hosted an online event informing far more than 100 different medical device manufacturers from all around the globe about China’s New Regulations. Qualtech’s team thereby detailed the important updates that the new RSAMD will bring, including the new obligations for product registrants under the nationwide adopted MAH system.

• 2021-08-02 06:26:52

On July 2nd, Qualtech had been invited to present and inform Japanese OMETA Members (Overseas Medical Equipment Technical Assistants) on the medical device regulation updates in Thailand, the Philippines, and Vietnam during the OMETA Online Seminar.