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 29th 2018, explain some important points that can be used by the applicant in preparing submission documents.



Important point


Letter of Authorization

  1.  Must include the authorization period
  2.  Must be legalized by Indonesia embassy


Standard and declaration of conformity

Attached are the standard reference,  for example:



Include a list of materials or components


Manufacturing flowchart

  1.  Make it in the form of a flowchart
  2.  Include the "in process control" point
  3.   If there is a process carried out by a 3rd party, please mention and attach the agreement


Finished Product Specifications

  1.  Mention the specification of the device completely
  2.  Give the working principle of the device
  3.  Give a picture with a description of the part of the picture


Validation of the Sterilization Process

  1.  Validation SOP (Make sure the SOP includes the products that are registered)
  2.  Validation Report (most recent)


Pre-clinical studies

  1. Biocompatibility Test Results
  2.  For materials that are commonly used, can attach a literature study (published)


Result of the research on any device containing biologic material.

  1. Results of research on biological material used
  2. Attaching a certificate issued by an authorized agency states that the animal used as a source of material is free of disease


Risk analysis of device

Refer to ISO 14971: Medical devices - Application of risk management to medical devices or on GHTF / SG3 / N15R8 documents


Result of Risk Analysis

Refer to ISO 14971: Medical devices - Application of risk management to medical devices or on GHTF / SG3 / N15R8 documents


Specification and/or requirement of raw material

  1.  CoA raw materials from suppliers
  2.  Raw material requirements     specified by the manufacturer


Results of analytical tests or results of clinical trials and safety of medical devices

  1.  Final QC Report or CoA
  2.  Sterility Test (at least last year)
  3.  The expiration period must be supported by stability data
  4.  Every claim must have supporting data



  1. Label design on packaging
  2. Attach to all sizes. If the label design is all the same size, please write "This label design applies to all sizes"
  3. List product name and type, specifications, manufacturer name & address, placement of registration number (RI Ministry of Health AKL ......)


Symbol and Explanation

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


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


Product code

  1. List examples of writing SERIAL NUMBER/BATCH/LOT
  2.  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


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 size / variant details 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: BALLERINA Contact Lens

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