CHINA: Innovative Development Plan of Introducing Drug and Medical devices in Guangdong, Hong Kong, Macao and the Greater Bay Area
- 2021-01-19 02:48:31
CHINA: New Guideline on Application of Real-World Data in Clinical Evaluation of Medical Devices
- 2021-01-19 02:38:54
NMPA's newly released Guiding Principles explain the general, principled and forward-looking requirements for the application of real-world data of medical devices in clinical evaluation.
More THAILAND: Introduction of New Medical Device Complaint Channel, Complaint Record and Management System for Inspection
- 2020-12-24 11:02:25
Thai FDA is committed to ensuring utmost standard, quality and safety of medical devices marketed in Thailand is consistently kept. Hence, they have announced a new medical device complaint channel, complaint record and management system for inspection. This decree is beneficial in providing assurance to consumer regarding safety and prevention of comparable adverse event in the future.
More THAILAND: List of Medical Device Standards for Compliance by Disposable Surgical Masks
- 2020-12-24 10:54:11
Thai FDA has recently announced a list of standards to be complied by disposable surgical masks, upon making a set of COVID-19 related medical devices announcement.
More THAILAND: Advertising Specifications for Advertising License Exempted Medical Devices
- 2020-12-24 02:53:02
A person who wishes to advertise a medical device in Thailand must obtain a medical device advertising license upon any medical devices marketing activity. Thai FDA had published further advertising announcement regarding the advertising specifications of medical devices that are exempted to proceed advertising license registration to conveniently advertise medical devices.
More THAILAND: New Guidance Document on Labelling of Medical Device
- 2020-12-24 01:55:33
Ministry of Public Health has introduced a new guidance document regarding labelling of medical devices to be registered and sold in Thailand. This is to ensure consumers safety, as well as distributing accurate and sufficient medical device information.
More VIETNAM: New circular for managing bidding process for medical devices in public health establishment
- 2020-12-23 07:07:34
The Vietnam Ministry of Health has issued Circular No. 14/2020/TT-BYT dated 10 July 2020 (“Circular No. 14“), which regulates various aspects of the bidding process of medical devices for public health establishments. This circular took effect on 1 September 2020.
More MALAYSIA: New Medical Device Database: Medical Device Authority Register (MDAR)
- 2020-12-23 02:21:33
MDA has announced a new search database, Medical Device Authority Register (MDAR).
More MALAYSIA: New Guidance Document for Advertisement For Medical Device Requirements
- 2020-12-23 02:15:03
MDA has come up with a new guidance document incorporating the 2019 published Medical Device Advertisement Regulation.
More TAIWAN: New Draft on “Requirements for Indicating the Unique Device Identifier on Medical Device Labels"
- 2020-12-23 02:01:32
TFDA has recently announced a 3-stage schedule of implementing UDI system on labels of medical devices. Starting from June 1st, 2021, class 3 implantable medical devices are the first round of products that are required to comply with this regulation; followed by class 3 non-implantable medical devices starting from June 1st, 2022, and finally, class 2 medical devices starting from June 1st, 2023.
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