• 2023-05-24 07:21:35

The Japanese MHLW has issued a complimentary notice to explain further about cybersecurity of the Essential Principles Requirements.

• 2023-05-24 07:15:51

The applicable expedited route from the Thai FDA supplies much-needed clarity for manufacturers, allowing them to better forecast the potential impact on timelines and costs for certain products. The selection of expedited routes allows applicants to comply according to their medical device approval status.

• 2023-04-25 01:51:22

The Indonesia Ministry of Health issues circular letter no HK.02.02/E/359/2023 that regulates new requirements for the labelling of Rapid Diagnostic Antigen COVID-19 Nasal Swab Method with Self-Testing Claim.

• 2023-03-27 08:52:43

PFDA presented a draft of the updated guidelines on obtaining a special permit for restricted use of unregistered drug and medical device products. In addition to previous patient conditions laid out by previous regulations, this new guidance widens the product scope to vaccines and the diseases to include those that may result in the patient's permanent disability.

• 2023-03-27 08:27:31

Thai FDA announces 'Thailand FDA - WHO Collaborative Registration Procedure (CRP) for in vitro diagnostics (IVDs)', an expedited medical device registration program aimed at reducing the time required for manufacturers and importers to register their products. The program officially commenced on December 28, 2022, onward.

• 2022-09-27 07:35:39

In 2000, Qualtech was established in Taipei. Since then, Qualtech has established several locations around the world. Over the years, Qualtech has always insisted on providing high-quality medical equipment services such as regulatory consultation, product registration, clinical design and implementation, local authorized registration, and post-market surveillance. In addition to providing professional services, we also do not forget the social responsibility that belongs to Qualtech. Since Qualtech is engaged in the medical-related industry, we focus more on helping and caring for underprivileged groups.

• 2023-02-23 01:23:58

Thai FDA has published a guidance, which aims to assist the justification status of Software as Medical Device (SaMD) as well as its risk classification for Thai FDA registration.

• 2023-01-20 09:12:04

Enter EU market with confidence: Keep updated on MDR Regulation changes! Join Qualtech MDR webinar on 07 Feb 2023 (Tue) at 16:30 – 17:30 p.m. (GMT+8).

A perfect opportunity to prepare for the changes and minimize the impact on you.

• 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.

• 2023-01-19 01:28:15

As we are easing into the first quarter of 2023, we are thus simultaneously entering into the last phase of Thai FDA grace period regarding the transition to the risk-classification approach. Thus, Thai FDA has published a summary of the medical device categories on their official website instructing medical device registration via Full CSDT submission and Partial 2 Submission route.