Introduction to Medical Device Registration in Indonesia

Introduction to medical Device Registration in Indonesia

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Introduction to Medical Device Registration in Indonesia

This article deals with the medical device registration in Indonesia.Indonesian Ministry of Health (MOH) is the authority to issue the certificate for medical devices. Regulation of medical devices started in Indonesia in 1991 to ensure the safety quality, performance efficiency, affordability and appropriateness. Health Care is a priority in Indonesia and it gives excellent oppotunities to foreign exporters of medical devices and eqiupment. Indonesia medical device regulation system is divided into 2 system,

1 Pre Market Control

a. Manufacturer license

b. Distributor license

c. Registration license

2 Post Market Control

a. sampling

b. Monitoring

c. Vigilance

d. Advertising

Determination of classification of medical devices

Medical devices and IVD classification in Indonesia has followed ASEAN medical device directive (AMDD) and has been classified under 4 categories ( from A to D) on risk level.

Agent

An agent is the only legal importer and distributor in Indonesia having the distribution license (IPAK) issued by the MOH RI, and companies must have one such agents to import products and distribute in Indonesia. Companies that have Distribution License (IPAK) issued by the MOHRI, only can be the agent and all the import products must have only one legal importer and distributor in Indonesia.

Documents needed

The following documents are required for the registration of medical devices in Indonesia,

1. Production license of medical device

2. Distribution license for the distributor

3. POA from the manufacturer / Principal to the appointed product holder

4. Letter of Authorization with minimum 2 years term agreement legalized by the Indonesian Embassy (KBRI)

5. ISO 13485 Certificate

6. FSC issued by MOH or Competent Authority

7. Certificate of Analysis of Finished product

8. Performance / functional test efficacy test

9. Performance / characteristic evaluation (IVD products)

10. Production flow chart

11. Risk management according to ISO 14971:2007

12. COA Raw Material

13. Clinical Studies Evaluation Data

14. Biocompatibility Test

15. Published Journal

16. Post Market Evaluation Procedure

17. Labelling with Product Name (batch num, Lot num, expiry date ect. )

18. IFU and manual printed in Indonesian and English language

19. Brochure and leaflet in Indonesian and English language.

Process

After the internal evaluation of the documents, the documents are submitted by the in-house experts to the MOH for a thorough evaluation of all the docucments submitted. There are 3 steps in submission of the documents.

Step1

As per the requirement, the docucments are checked and arranged, then the submission is done along with the reistration fees.

Step 2

If all the documents are in place, the process moves on to Step 3, if not, MOH will issue a deficiency letter to the applicant and then the applicant will submit a compliance Dossier to ID MOH.

Step 3

The documents are then sent to the next approval level to issue certificate draft, the applicant should check if the information in the certificate is correct and then the Final marketing authorization certificate is issued.

Timelines

The timeline in days is given below

Importations

Validity of registration is minimum 2 years and a maximum 5 years. All medical devices must get a registration number before entering the Indonesian Territory. Accessories and other spares are not required to be registered. All accessories of the products will be attached in registration number in order to simplify the custom release. On receipt of the registration and the product distribution number from the ministry of health, the company can start to sell the prodcut in Indonesia.