• 2021-09-29 02:11:24

MDA wants to advise any organization interested to import and distribute the Covid-19 Self-Test Kit for the Malaysian market to apply through the Conditional Approval Application with MDA.

• 2021-09-29 02:05:59

Starting July 1, 2022, MDA will start to fully enforce the Medical Device (Duties and Obligations) Regulations 2019 or better known as 2019 Regulations. The regulations focus on various medical device-related establishments’ responsibilities on post-market activities.

• 2021-09-29 00:33:56

HSA recently issued updates to some pre-market registration-related guidance documents and technical reference documents. Specifically, the GN-15, GN-17, GN-18, TR-01, and TR-02 were updated. The changes mainly deal with the addition of cybersecurity requirements for medical devices. This is a very important update since it is imperative to protect devices that are used in the healthcare industry from hackers and other cyberthreats.

• 2021-09-29 00:29:09

The TGA has recently published a guidance document of an overview for patient information materials. The patient information materials consist of patient information leaflets (PIL) and patient implant cards (PIC), for implantable medical devices and active implantable devices. From December 1st, 2021, all implantable or active implantable devices will require patient implant cards and patient information leaflets, unless they are specifically excluded from these requirements.

• 2021-09-29 00:25:11

In order to further standardize the generic names of medical devices and strengthen the management of the whole life cycle of medical devices, NMPA has organized and formulated six naming guidelines.

• 2021-09-29 00:18:14

Thailand’s Ministry of Public Health has recently approved the import permit exemption of 24 additional Sars-CoV-2 (COVID-19) related Medical Device(s), for donation purposes.

• 2021-09-29 00:09:37

Back in July 2021, Indonesia’s Ministry of Health announced that oxygen cylinders that do not have thermally insulated containers and are not designated for oxygen gas, are no longer to be considered as medical devices.

• 2021-08-02 04:41:50

HSA has recently released the “Guidance on the Medical Device Unique Device Identification (UDI) System”. From 2022 in transitioning phases, HSA requires medical devices to be marketed in Singapore to be equipped with UDI-DI.

• 2021-09-06 06:11:51

Qualtech Consulting would like to invite you to our free online Webinar on the subject of "Japan Medical Device Registration". Our event is scheduled to be held on September 17th (Friday), 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.