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TAIWAN: Enforcement of “Medical Device Act” and “Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License”

TAIWAN: Enforcement of “Medical Device Act” and “Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License”

  • 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.

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THAILAND: Introduction of New Medical Device Complaint Channel, Complaint Record and Management System for Inspection

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.

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THAILAND: Food and Drug Administration Announcement Regarding Technical Documents Preparation for Inspection Purpose 2020 – November,2020

THAILAND: Food and Drug Administration Announcement Regarding Technical Documents Preparation for Inspection Purpose 2020 – November,2020

  • 2020-11-26 01:31:52

Thailand is currently gearing up a step closer toward the transition of Thailand future regulation from Policy – based Classification to Risk-based Classification as Thailand’s Food and Drug Administration announced that it is mandatory for importer to prepare Technical Documents (CDST Dossier) upon importation by the period as follows : 1) Class 1, 2 and 3: 13 June 2021. 2) Class 4: 11 September 2021. Licensee who fails to comply with ThaiFDA must be sentence to penalty condition is as follows:
1. Licensed and Notified Medical Device: Shall be liable to imprisonment for a term not exceeding 1 year or fine not exceeding 100,000 THB or both.
2. General Medical Device: Shall be liable to imprisonment for a term not exceeding 6 months or fine not exceeding 50,000 THB or both.

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CHINA: The Chinese government takes further steps on adjusting the qualification criteria of inspection and testing Institutions – June, 2019

CHINA: The Chinese government takes further steps on adjusting the qualification criteria of inspection and testing Institutions – June, 2019

  • 2020-05-06 07:09:04

The regulations of examination for testing institutions in China have been changing for the past 2 years. Currently the State Administration for Market Regulation (SAMR) plans to re-organize the structure of testing centers, from solely permitting official institutions to now also opening up the procedure to public 3rd-party testing organizations.

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