Introduction to Medical Device Registration in Indonesia 

This article deals with the Medical Device Registration in Indonesia. The Ministry of Health Republic of Indonesia (MOH RI) is the authority to issue the Certificate for the 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 opportunities to foreign exporters of Medical devices and equipment. Indonesia Medical Device Regulation System is divided into 2 systems:

(1)   Pre Market Control

(a)  Manufacturer License

(b)  Distribution 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 the IVD classification in Indonesia has followed Asean Medical Device Directive (AMDD) and has been classified under 4 categories (ABCD) based on Levels of risk.

Class A  Low Risk Device

Class B  Low Moderate Risk

Class C  High  Moderate Risk

Class D High Risk. 

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 yrs 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 etc)
  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 documents submitted. There are 3 steps in submission of the documents

Step 1    

As per the requirement, the documents are checked and arranged, then the submission is done along with the Registration Fees.

Step 2

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

Class AClass BClass CClass D
Ist Evaluation15303045
Compliance10101015
2nd Evaluation10101010

Importations

Validity of Registration is minimum 2 years and a maximum of 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 product in Indonesia. 

How can Morulaa Help ?

Morulaa HealthTech as successful Regulatory and Import Consultants have delivered high levels of professionalism towards our clients. To understand how the regulatory approval system works in Indonesia and other SouthEast Asian Countries, Contact Us to know more. 


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