Home About Qualtech NEWS INDONESIA: Class Determination Process Independently on Registration of Marketing Authorization Medical Device and PKRT (e-Regalkes) By The Applicant - November 2018
INDONESIA: Class Determination Process Independently on Registration of Marketing Authorization Medical Device and PKRT (e-Regalkes) By The Applicant - November 2018

12 Nov, 2018

Based on the provisions stated in Republic of Indonesia Minister of Health Regulation no. 62 year 2017 and the socialization of procedures for classification of Medical Devices and PKRT, MoH announced the enactment of class determination and the making of billing codes independently by the applicant. Related to the process, MoH facilitates the availability of Guidline classes available on the Regalkes website. This is to facilitate the applicant and prevent errors in class determination. If there is an error in determining the class, it will certainly affect the registration fee as follows:

1. If the applicant makes a mistake in determining the risk class, the excess / lack of registration costs is the risk of the applicant.

2. The evaluator will notify the application during the 1st comment if the class is not suitable for the device and the applicant need to pay additional fee if the class determine by MoH is higher than initial. MoH will offer new biling code to the applicant.

3. If there is an excess of registration fee payment, then the fee cannot be refunded or transferred to another application

Due to the improvement of the e-Regalkes system, the time for implementing the class determination independently by the applicant will be further notified through the Regalkes website.

 

Reference:

1) Proses Penentuan Kelas Secara Mandiri Pada Registrasi Izin Edar Alat Kesehatan dan PKRT (e-Regalkes) oleh Pemohon 

2) Penundaan Proses Penentuan Kelas Secara Mandiri Pada Registrasi Izin Edar Alat Kesehatan dan PKRT (e-Regalkes) oleh Pemohon

 
Home About Qualtech NEWS INDONESIA: Class Determination Process Independently on Registration of Marketing Authorization Medical Device and PKRT (e-Regalkes) By The Applicant - November 2018