Thailand: Thai FDA Issues Guidelines and conditions for submission of medical device product diagnosis - May, 2018
- 2020-08-06 09:09:52
Thai FDA published an eye-related product classification checklist guide to help determine whether each product fall under the category of not medical device, medical device, drug, or cosmetic.
MoreTFDA Department of Medical Device and Cosmetics is set to move to a new office starting on April 30, 2018. The new office will be located at the Alley 12, 2nd Section of Yan Jiu Yuan Road, Nangang District, Taipei City.
MoreCFDA has released the draft of 3D-printed medical device guidance during the last week of February. The draft guidance provides the general requirements of registration rules on 3D printed medical device.
MoreThe state council of China issued a cabinet report during the congressional sessions in March. China government plans to reform many agencies and establish a new administration, market supervision administration. The affected agencies include the State Administration of Industry & Commerce,
MoreMedical device regulations in China have changed frequently in the recent years, such as updating of multiple national standard andindustry standards, issuing of product guidance and administrative directives. With its 10-year experience in China's active medical device registration,
MoreThe Unique Device Identification (UDI) system is a set of alphanumeric codes that serves to enhance monitoring activities for medical devices. It consists two parts: (1) UDI (an array of alphanumeric codes) and (2) UDI carrier which come in three distinct types: (a) QR code, (b) Bar code, or (c) RFID/NFC.
MoreThe applicant may initiate the cancellation of the registration license of imported medical equipment to CFDA. This administrative application will not charge any application fee. The applicant shall prepare the submission documents to cancel the application. The CFDA will conduct a formal review on the cancellation application.
MoreThe Guidelines released by the Department of Health concerning Medical Device Registration is in place to be officiated following its publication. This shall be implemented a year after its effective date. Delayed implementation allows sufficient preparation for applicants in securing technical documents crucial to the registration process.
More"The Guidelines for Accepting Overseas Clinical Data of Medical Devices" (hereinafter referred to as the "Guideline") was promulgated last January 11, 2018. CFDA has declared that they will be accepting overseas clinical trial data of devices registered in China.
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