Medical Device Registration Indonesia A Complete Guide

This article discusses medical device registration in Indonesia. The Ministry of Health Republic of Indonesia (MOHRI) is the medical device regulation authority of Indonesia, which functions as the issuing authority for the certificate for the Medical Devices. The regulation of medical devices in Indonesia started in 1991 to ensure safety, quality, performance, efficiency, affordability, and appropriateness. The health care sector is considered highly prioritized in Indonesia and presents an excellent opportunity for foreign exporters of Medical Devices and Equipment.

 The Indonesia medical device regulation system is divided into 2 systems: 

Pre Market Control

1. Manufacturer License

2. Distribution License

3. Registration License

Post Market Control

1. Sampling

2. Monitoring

3. Vigilance

4. Advertising

Indonesia Medical Device Classification: Risk Based Approach

Classification of Indonesian medical devices and also classification of IVDs in Indonesia is done following AMDD and classified into 4 categories (ABCD) based on levels of risk.

Agent

The Agent is the sole Legal Importer and Distributor in Indonesia with the Distribution License (IPAK), granted by the MOH RI as the Primary Indonesia Medical Device Regulatory Authority Workflow. There should be at least one agent for each company to import and distribute the products in Indonesia. The companies that possess Distribution License (IPAK), granted by the MOHRI, can be agents but there will be just one Legal Importer and Distributor in Indonesia.

Indonesia Medical Device Registration Requirements and Essential Documents

The below items are part of the basic requirement for the registration of Medical Devices in  Indonesia:

1. Production License for the Medical Device

2. Distributor License for the Distributor

3. Power of Attorney of the manufacturer/Principal to the appointed product holder.

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

5. ISO 13485 Certificate

6. FSC by MOH or the Competent Authority of Indonesia

7. Certificate of Analysis for the finished product

8. Performance/Functional efficacy test

9. Performance/Characteristic evaluation (for IVD products)

10. Flow Chart of production process

11. Risk Management according to ISO 14971:2007

12. COA of Raw Materials

13. Clinical Study Evaluation Data

14. Biocompatibility test

15. Published Journal

16. Post market evaluation procedure

17. Labeling with Product Name (batch num, Lot num, expiry date etc)

18. IFU and manual in Indonesian and English Language

19. Brochure and Leaflet in Indonesian and English Language.

Step by Step Process for Medical Device Registration Indonesia

Once the internal review of the documents is completed to ascertain their compliance with the entire list of Indonesia medical device registration requirements, the documents are then forwarded to the MOH by the in house experts for further evaluation. The procedure for the submission of the documents is as follows:

Step 1: In accordance with the medical device regulations in Indonesia, the documents are reviewed and arranged before submitting along with the Registration Fees.

Step 2: When the documents are found to be complete, the process proceeds to Step 3. But in case there is a deficiency, the Indonesia medical device regulatory body will issue the Deficiency letter to the applicant and then the Compliance Dossier is submitted by the applicant to the ID MOH.

Step 3: The documents are then forwarded to the higher approval level to issue the Certificate Draft. After verifying the accuracy of the information on the certificate, the Final Marketing Authorization Certificate is issued.

Timeline for Medical Device Registration Indonesia

The timeline in days is given below based on the standard Indonesia medical device classification:

Importations

Medical Device Registration validity in Indonesia ranges from a minimum of 2 years to a maximum of 5 years. Registration Number must be issued to all Medical Devices before entry into Indonesia. Accessories and other parts do not need to be registered. All accessories of the product will be indicated in the registration number for the purpose of simplifying the Customs release. Upon receiving the registration number and the product distribution number from the Ministry of Health, the company may begin to market the product in Indonesia.

How Morulaa Health Tech Can Help with Medical Device Registration Indonesia

We, at Morulaa Health Tech, have been able to provide very professional services in regards to helping our clients with their needs in regulatory and import of their products in Indonesia medical device regulation and Indonesia medical device registration. If you would like to learn more about the process of regulatory approval in Indonesia and other Southeast Asian countries, contact us today!