12 Nov, 2018

MDCO has created and developed a Web-based In Vitro Diagnostic Medical Device Classification Program, where previously only the classification program for General Medical Device was available. This is to facilitate the classification of the In Vitro Diagnostic Medical Device according to its risk level under the Medical Device Administrative Control System.

This programmed classification is the same as the classification program for the General Medical Device, which contains related questions to find out the characteristics or characteristics of the medical devices that the applicant has and available "Yes or No" answers to the questions. Based on these answers, it will be the reference for the Classification Program to conclude the class that is suitable for the medical devices that the class is looking for.

The Classification program is available on the MDCO website, to access it, can be seen from the menu "Frequently Asked Question" Medical Device Administrative Control System, then on the Classification of Medical Device menu, click the Web-based In Vitro Diagnostic Medical Device Classification Program or can access via the link following:

Web-based In Vitro Diagnostic Medical Device Classification Program

With this Classification Program, it will be easier for the Applicants and no need to open the Guidance Classification file for In Vitro Diagnostic Medical Device files.

 

Reference:

MDCO: To facilitate the classification of an in vitro diagnostic medical device according to its risk level under the Medical Device Administrative Control System, a "Web-based In Vitro Diagnostic Medical Device Classification Programme" has been developed and posted for your use.