September 17, 2018

In carrying out the medical device registration process in Indonesia the applicant must fulfill administrative and technical documents requirements. However, during the registration process MoH still found that applicant does not provide complete documents which will cause on application rejection. MoH during the seminar on August 16th 2018, explain some important points that can be used by the applicant in preparing submission documents.

ID R1

  

Other things to look for, including:

  • The product name must be consistent (in each document MUST be the SAME)
  • List of accessories do not forget to fill in the D-5 form
  • The product name listed on the CoA or Final QC Report must be in accordance with the product name registered
  • Product name writing includes: Brand + Generic Name
  • Example: ELSA Examination Lamp

Based on the above evaluation, it is expected that there will be no more errors or lack of registration documents.

  

Source:

https://regalkes.depkes.go.id/#home/berita/1000417

https://drive.google.com/drive/folders/1yVVAK4dhylzqP5yghwVLAB1wugJNedMV

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