Home About Qualtech NEWS THAILAND: Amendment to the Guidelines for Preparation of Documents (CDST) for Non-IVD Device and for Medical Devices – January 2019
THAILAND: Amendment to the Guidelines for Preparation of Documents (CDST) for Non-IVD Device and for Medical Devices – January 2019

January 15, 2019

Starting from October 2018, the Medical Device Control Unit has changed the language used in applying for a license in the CDST guidelines in order to facilitate the filing of medical devices to be licensed and medical device to be notified from "xx" to "xx" as follows.

Clause 6 (Executive Summary)  Change of message from "English and Thai translation which corresponds English, except domestic products, which must be in Thai" to "English, except domestic product can choose whether to file in English or Thai"                                               

Clause 7 (Essential Principles of Safety and Performance of Medical Devices and Method Used for Demonstrate Conformity) Change of message from "English, except domestic product" to "English, except domestic product can choose whether to file in English or Thai"                                                                                        

Clause 8 ( Device Description and Features) Change of message from "English and Thai translation which corresponds "English, except domestic products, which must be in Thai" to "English, except domestic product can choose whether to file in English or Thai"                                                         

Clause 9 (Summary of Design Verification and Validation Documents) Change of message from "English, except domestic product" to "English, except domestic product can choose whether to file in English or Thai"

Clause 10 (Device Labelling) In accordance with the rules, procedures and conditions announced by the Minister.                   

Clause 11 (Risk Analysis) Change of message from "English, except domestic product" to "English, except domestic product can choose whether to file in English or Thai"                                                                                      

Clause 12 (Manufacturer Information) Change of message from "English except domestic product" to English, except domestic product can choose whether to file in English or Thai"

 

Reference:

Official press

 

 

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Home About Qualtech NEWS THAILAND: Amendment to the Guidelines for Preparation of Documents (CDST) for Non-IVD Device and for Medical Devices – January 2019