No Document Required

Letter of Authorization (LoA)

(Need legalized by Indonesia’s embassy or ApostilleHard copy
1 require to be posted to Indonesia
Prefer a 5 years validity since the license's expiry will be the
expiry date of the LOA.)

2 Certificate of Free Sale (CFS)

3 ISO 13485
4 CE Certificate
5 Marketing History
6 Declaration of Conformity
7 Raw Material/ (MSDS for diagnostic product)
8 Manufacturing Process (Flow Chart)
9 Brochure/Product Specification
10 Sterilization Report and Validation Data
Biocompatibility data (pre-clinical physical test data report &
11
pre-clinical animal studies)
12 Software Validation (if applicable)
13 Material biology report (if applicable)
14 Clinical evaluation report
15 Risk Analysis / Risk management report
16 Packaging specification (for diagnostic product)
17 Shelf Life / Stability Studies Report
IEC 60601 :
- For electomedic equipment
18
- IVD Product, IEC 61010 issued by testing laboratory or notify
body
Certificate of Analysis (CoA) of finished product
19
(Must have results of test, not just pass/fail)
20 Label
21 IFU
 Explanation of Batch Number
(Document explaining the meaning of the
22
sequence/numbers/letters in the batch numbers To be in
company’s letterhead)

23 List Accessories
 Remarks

LOA need to apostille

Ok
Ok
please provide the document
please indicate which countries have registered and sold this product.
DoC ok but need the applied standard
msds ok but need raw material with quantitative data and qualitative data
please provide the flow chart
Please provide the brochure
please provide the document
not applicable
Please provide the document
not applicable
Please provide the document
Please provide the document
Please provide the document about the packaging specification (size, shape, colour the packaging)
Please provide the document

Please provide the document

Please provide the document

Please provide the label
Ok
Please provide the document

please provide the accessories