No

Documents

Important point

A-3

Letter of Authorization

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

A-7

Standard and declaration of conformity

Attached are the standard reference,  for example:

B-11

Material

Include a list of materials or components

B-13

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

C-1

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

C-3

Validation of the Sterilization Process

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

C-4

Pre-clinical studies

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

C-6

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

C-8

Risk analysis of device

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

C-9

Result of Risk Analysis

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

C-10

Specification and/or requirement of raw material

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

C-13

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

D-1

Labelling

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 ......)

D-2

Symbol and Explanation

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

D-3

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

D-4

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

E-5

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.