Registration requirements of Medical devices Electromedic (UNIT) as follow :

1. Letter of authorization ( LOA ), from the issued country which has been legalized by the
Indonnesia Embassy.

2. Valid Certificate free sale which is showing registered product from MOH country of
origin of the manufactured

3. If the LOA and CFS are issued from different company , it will requires statement letter
which is shows the relationship corporation between those two companies

5 Valid Declaration of Conformity that outlines the standards are to be used in any
manufacturing of products

6 Valid ISO 13485

7 Valid CE Certificate

8 Product summaries in Bahasa and English language which is contain as follow : product
description, the intended use, indication, marketing history, the formula has been used,
the working mechanism of the equipment.

9 The explanation of how to use the equipment

10 Process production flowchart

11 Color images brochure that include the Specifications of equipment

12 Test report of IEC 60601 full page complete with certificate issued by accreditation
laboratory.

13 The performance test of equipment or QC test Pass which is issued by the QC

department device manufacturers

14 Test report biocompatibility issued by accreditation laboratory

15 clinical evalution that state product safety and efficacy

16 Manual Book in English language

17 Attachment accecories tool if available, please give the detail in excel or word format
(accessories must be listed in the manual book)

18 Serial numbering system complete with the meaning from the company manufacturer.

19 The procedures used in the recording system , the handling of complaining and the
process of taking the defective goods from customer (the Procedure recall / Post market
evaluation from device manufacturers and distributors)