Table of Contents
Medical Device registration in Indonesia: Requirements
1 Regulatory Approval from GHTF Countries such as 510(k) / TGA / CE etc. if applicable.
FORM A
2 Medical Devices Distributor License (from importer), This must cover the product category.
3 Letter of Appointment must be legalized by Indonesia embassy in country of origin, expiry date should be more than 2 years.
4 Certificate of Free Sale (CFS) scanned in colour
5 Executive Summary including information on marketing history; regulatory approval status where the products had been or in the process of registering; adverse event or FSCA report, if any.
6 Declaration of Conformity
7 Essential Principle Checklist
8 ISO 13485 scanned in colour
9 No Objection Letter to transfer the license should there be another party who already to hold the license (from importer)
10 Statement Letter of documents declaring originality (from importer)
FORM B
11 Product Description
12 Intended Use & Instruction For Use
13 Indication, Contra-Indication
14 Warning and Caution
15 Potential adverse event & Alternative Therapy, if applicable
16 Material if applicable
17 Manufacturing flow chart
FORM C
18 Product Specification
19 Raw Material Specification
20 Certificate of Analysis or functional/performance test
21 Stability, sensitivity, specificity, testing Report
22 Pre-Clinical testing report / Biocompatibility
23 Verification and Validation Test Report
24 Sterilization by the third party :
a ISO 13485 for sterilization facility
b Sterilization Test Report and Certificate issued by 3rd Party Sterilizer
25 Clinical Evaluation Report
26 Test report for biological product, if applicable.
27 Clinical Evaluation
28 Risk Assessment / Risk Management
29 Packaging specification
FORM D
30 Labelling containing product photos
31 Brochure
32 Instruction for Use
33 Production Code/Serial Numbering System
34 List of Configuration/ List of Accessories
FORM E
36 Complaint Handling Procedure (from importer)
Authority website
Frequently Asked Questions (FAQ)
Can we transfer license from one license holder (LH) to another?
Yes. But the process will be same as new registration. There will be a new license number.
If yes, do we need current LH’s permission?
Yes.
What documents are required for license transfer (written consent from current LH)?
The Letter of Authorization (LoA) from principal to new LH, termination letter from principal to current LH, no objection letter from current LH (including their willingness to bring the registration license back to MoH during transfer license). Other documents will be same as new registration.
How long will the transfer take if the current LH agree to the transfer?
From the date of complete submission, Class A : around 1.5 months, Class B/C : around 3 months, Class D: around 4-5 months
During the transfer, can principal export products to Indonesia?
Can principal sell the products from current local distributor’s warehouse to hospital?
Yes, please put in the current LH’s objection letter that they will support until the new license is issued.
Can principal re-register a product under a new license holder?
No. 1 brand can only be held by 1 LH
What is the solution if the current LH don’t agree? And how is the related timeline?
Wait until the license is expired
Who will be the importer, only LH? Is it acceptable that LH authorize another importer or distributor to do importation?
Yes, only LH
How does distributor pays to principal?
Via LH, LH will transfer to Principal
What is the process for importing spare part for servicing purpose?
Apply statement letter if the product license is valid.
Apply for statement letter using obsolete license and letter from hospital/ user if product license is not valid.
Statement letter last for 2 years.
What is the process for renewal
Product license last for as long as 5 years depending on LOA. LOA and FSC is needed for renewal under same License holder importer.
Contact
Contact us here if you need more information on medical device registration in Indonesia.
