• 2021-06-29 11:23:58

On April 16th, Qualtech organized a webinar and guided participants through the Latest updates for medical device regulations in the Philippines, Thailand, and Malaysia. Our experts covered all the major topics and suggested details to pay attention to.

• 2021-06-25 13:01:35

Department of Medical Equipment and Constructions issued a draft Decree on medical devices management with a letter to collect comments on the draft Decree on March 31st, 2021.

• 2021-06-25 12:45:15

According to FDA Modernization Act, FDA publishes a series of recognized consensus standards modifications. FDA believes these modifications are closer to modern requirements for medical devices to ensure public benefit improvement. The medical device manufacturers should notice the standards change to avoid the FDA challenge.

• 2021-06-25 12:32:37

While the channel of distribution of a COVID-19 vaccine under the conditional approval scheme is rigorously controlled by the Thai FDA, a fast-track approval route was launched exclusively for more COVID-19 products even under the implementation of risk-classification regulation.

• 2021-05-22 06:49:37

Recently, NMPA issued a Notice on Registration of Medical Device Technical Dossier (No. 36 of 2021), which will facilitate medical device manufacturers to choose raw materials and key components, simplify registration declaration, improve the quality of medical device review and approval, establish a more scientific and efficient review and approval system, and encourage innovation.

• 2021-05-22 05:25:28

Medical Device Authority (MDA) published a second edition guidance document of Code of Advertisement (COA). The COA promotes the establishment of the standards for the ethical advertising of medical devices in Malaysia. COA also specifies the requirement for which situation requires approval or not from MDA.

• 2021-05-22 04:20:30

PFDA shared the updated procedure for the issuance of special certification for COVID-19 test kits following recent guidance for minimum performance requirements of different types of COVID-19 Test Kits.

• 2021-05-22 03:37:21

The US Food and Drug Administration (FDA) has published a new policy in the Federal Register, to modify identifications of medical software in classification regulations. There are some software functions that would no longer be regulated by the FDA. The new policy is effective immediately from the date of publication.

• 2021-05-22 03:30:32

In line with the risk classification transition, the Thai FDA has withdrawn the Ministry of Public Health’s exemption notice on surgical gowns, isolation gowns/coverall, disposable surgical masks, and disposable surgical masks N95, under Special Registration Route. Manufacturers must now apply the procedure according to the recently released risk-based classification requirements consistent with the ASEAN MDD.

• 2021-04-26 03:09:33

Medical Device Act, the act that separates medical devices from the genre of medicines under Pharmaceutical Affairs Act, will be fully implemented on May 1st, 2021. Along with Medical Device Act, Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License will come into force on the same date.