INDONESIA: Evaluation of Marketing Authorization Process for Electromedical Medical Devices – September, 2018

2020-02-12

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.

No

Documents

Important point

1

Letter of Authorization
  • Must include the authorization period 
  • Must be legalized by Indonesia embassy

2

Standard and declaration of conformity

Attach the standard reference, example:

3

Material

Include a list of materials or components

4

Manufacturing flowchart
  • Make it in the form of a flowchart
  • Include the "in process control" point

6

Finished Product Specifications
  • List the specifications in full
  • Give the working principle of the device
  • Give a picture with a description of the part of the picture

7

Analysis test result/clinical test result and device safety
  • Final QC Report or CoA (Make sure the QC Report Final document has been filled out and signed by the QC department)
  • IEC 60601 electrical safety test

8

Labelling
  • Product images must be clear and proportional in size
  • List product name and type, specifications, manufacturer name & address, placement of registration number (RI Ministry of Health AKL ......)

9

Symbol and Explanation

List the codes or symbols that are listed on medical devices or packaging / labels

10

Guidelines of usage, training material & guidance of installation and its maintenance

Include a manual / insert package /
instruction for use in English and Indonesian, at least containing the purpose of use, referring to use, contra indications, and warnings

11

Product code
  • List examples of writing SERIAL NUMBER/BATCH/LOT
  • Give meaning to the Serial Number/Batch/Lot, For example SN-AB2102, meaning AB code for product type, 21 code for type, 02 code for production number

12

Standard Operating Procedure, record management and product complaints handling, etc.

Complaint Handling Procedures and Forms and Recall Include:
Complaint Handling Procedure,
Complaint Form,
Procedure Recall.

  

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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TAG : medical device , registration， INDONESIA

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