• 2020-05-05 07:31:28

Registration of both local and foreign-manufactured medical devices in Malaysia is generally a two-part process. They are mainly regulated by the Medical Device Authority (MDA) of Malaysia, a local regulation and authorization body.

• 2020-05-06 05:39:48

HSA constantly improves the quality of guidance documents with the periodical revision of the same. Just recently, HSA made minor revisions for GN-02 and GN-15.

• 2020-05-06 05:29:23

HSA has conducted an industry briefing last March 28, 2019 regarding the guidance revision for Change Notification (CN) which aims to address typical concerns that results in confusion among stakeholders. Additional updates on the requirements for CN applications were also added.

• 2020-05-06 01:39:35

A team of Qualtech managers and regulatory specialists participated in the OMETA Seminar in Indonesia last month from March 05 to March 08.

• 2020-05-05 09:53:48

The Indian government has issued draft Quality Control Orders (QCOs) for medical electrical equipment, sphygmomanometers, clinical electrical thermometers, blood glucose monitoring system, gloves and surgical blades, to better ensure their safety and effectiveness.

• 2020-05-05 09:22:34

Seeking for the public comment for 3 three months, ThaiFDA amended “the Draft of the Product Containing Alcohol for Humans and Animals Sterilization” on several points, including the scope of the guideline, the verification report and labelling etc.

• 2020-05-05 09:19:30

As security attacks and threats brought by outside connectivity are on the rise, Health authorities from Asian countries have started taking necessary measures to protect the public. Here's an overview of the current situation of Cyber-regulations in Asia

• 2020-05-05 08:05:23

HSA requires Class A devices to be listed in SMDR database prior to importation and selling in Singapore. GN-22 includes this list of Class A medical devices of which an item was recently revised by HSA.

• 2020-05-05 07:53:33

HSA introduced evaluation routes to hasten the registration of high-risk devices. GN-15 contains the details of each routes. The latest update for GN-15 (version 7.2) improves the criteria for class B devices to undergo Immediate Class B Registration (IBR) Evaluation Route.

• 2020-05-05 07:40:26

HSA uses post market monitoring in ensuring the safety of medical devices entering the Singapore market. GN-10 guides manufacturers on the steps in reporting hazards to these medical devices. HSA released version 3.5 of GN-10 with minor revisions last January 2019.