REQUISITE OF DOCUMENTS FOR TAKE CARE OF LICENSES TO MOH

1. FORM A ( ADMINISTRATION DATA )

A.3 :
JCopy of POA (Power of Attorney) / LOA (Letter of Authorization) as sole agent or sole
distributor/ distributor who has authorization from principle/ manufacturer to register the
medical device at Ministry of Health which legalized by KBRI ( ID embassy in country of
principle/ manufacturer). POA needs to listed product codes.

A.4 :
Give the Certificate of Free Sale from authorized institutions (For Medical Devices imported)
A.5 :
Attachment File of ISO 9001
Attachment File of ISO 13485
Attachment File of License CE
A.6 :
Executive Summary Product (short)
Marketing History
Work mechanism
The intended use
Formula / Components
History of Use
A.7 :
For imported medical devices provide the Declaration of Conformity of the factory

2. FORM B ( PRODUCT INFORMATION )

B.1 :
Description of tooltips
B.2 :
Description and features of Medical Devices
B.3 :
Description of The Intended Use
B.4 :
A general description of the diseases or conditions that can be diagnosed, treated,
prevented, or alleviated by these tools.
B.5 :
- Instructions for use of tools
B.6 :
Contraindication
B.7 :
Warning

B.8 :
Attention
 B.9 :
Potential Effect Desired
B.11 :
Material / Name of Raw Materials
B.12 : Manufactory Information
Summary or reference or contain documentation relating to the production process,
including measurements of quality assurance, which is adequate in accordance with the level
of complexity and the level of risk tools. Or
B.13 :
Production Process

3. FORM C (Spesification and Quality Assurance )

C.1 :
Describe the functional characteristics and technical performance specifications tool
( Attached Certificate of Analyze
C.4 :
Please provide a summary of the verification plan and document validation. On certificate or
etc.
C.4 :
Pre-clinical studies with result on certifiacate or etc.
C.6 :
Results of research for the appliance containing biological material
C.7 :
Clinical Evidence. With certificate or etc.
C.8 :
Describe the risk analysis of the tool
C.10 :
Give the specifications and or raw material requirements
C.13 :
Attachment File Clinical Trial Results
Attachment File COA
Attachment File QC Pass / Inspection Report

4. FORM D
D.1 :
Give an example of labeling / maring plate.
D.3 :
Give and explain user manuals, training materials and instructions for installation and
maintenance (In English and Indonesian)
D.4 : Give the production code and meaning.
Information
Attachement filw
D.5 :
List of Accessories