Class II & III Medical Device Registration in Indonesia

Every country has its rules and regulations for medical devices, which must be followed to bring the medical device to the market of the particular region. So, Indonesia has its own rules and regulations for medical device classification, manufacturing, and dispensing. The National Agency of Drug and Food Control (NADFC) also known as Badan Pengawas Obat dan Makanan (BPOM) functioning under the Indonesian Ministry of Health (MoH) is the regulatory body of Indonesia. The Ministry of Health (Kemenkes) is responsible for framing a broader framework of regulations for medical devices.

Medical device classification in Indonesia:

NADFC in Indonesia classifies medical devices under the category A, B, C and D. The classification is as follows:

Device Class	Risk Criteria	Examples	Review Period	Registration Fee
A	Low Risk	Oxygen masks, Surgical Gloves, etc.	15 days	US $115
B	Moderate Risk	Needles, Cuffs, Steam Sterilizers, etc.	30 days	US $230
C	Moderate-High Risk	X-ray Machines, Height Monitors, etc.	30 days	US $230
D	High Risk	Pacemakers, Cardiac Stents, etc.	45 days	US $340

Documents Required for Class II & III Device Approvals In Indonesia:

Registration of medical devices of class II and III in Indonesia is regulated by the National Agency of Drug and Food Control (NADFC). Regulation No. 62 / 2017 is applicable for medical devices of classes II and III. Once the medical device gets approved and you receive a license for the same it remains valid for 5 years. Following is the list of documents needed: 

1. Device Registration Form: The registration form should be filled out online for the registration of the medical device. 

2. Certificate Of Fee Sale (CFS): If the device originated in some other country and is sold over there, that country issues a CFC for the medical device, confirming that it is legally sold in that country. 

3. Product Specifications: This includes all the details of a medical device such as its purpose, specification, etc. 

4. Quality Management System (QMS): The medical device should have an ISO certificate confirming it follows international QMS guidelines.  

5. Clinical Evidence: It includes all the data of the clinical trials showcasing the safety, efficacy and therapeutic value of the medical device. 

6. Device Labelling: All the labeling should be done according to regulation No. 62/2017. 

7. Local Authorized Representative: A local representative from Indonesia should be appointed by the foreign manufacturers for handling all the regulatory process in Indonesia. 

8. Risk Management File: It is a document that enfolds all the risk analysis for the medical device and strategies for handling it.  

Indonesia medical Device Registration Process for Class II & III Medical Devices:

The process for class II and III medical devices involves a six-step process that begins with the online submission of the approval form for medical devices, then all the required documents as mentioned above in the required document part, are prepared and uploaded. Then the registration fees are paid and then the review process goes on. After that, the device gets approved if all documents are accurate and then post-marketing surveillance is done. 

So, ensure a smooth and speedy registration of your medical device of class II or III in Indonesia with our expert guidance. Contact us today to understand the NADFC approval process in Indonesia with Artixio! 

You can also view our other blog on medical devices. 

Artixio’s Services For Medical Devices Regulations: 

• QMS review and regulatory assessment (ISO 13485, 21 CFR Part 820) 

• Product Registration 

• Technical Documentation Review   

• Dossier Preparation  

• Response to Health Authority Queries 

• Device classification    

FAQ’s: 

1. How much time does it take for registration of Class II and III device in Indonesia? 

A: The estimated time for Class II devices is 3-6 months whereas for Class III it is 6-12 months. 

2. Is local clinical data required for Class II medical devices? 

A: No, local clinical data is not required for class II devices in Indonesia unless specified by the NADFC for certain device with high risk. 

3. Can foreign manufacturers register in Indonesia directly?  

A: No, foreign manufacturers are required to appoint a local representative in Indonesia to handle the regulatory requirements for medical devices in Indonesia. 

4.What are the requirements for class III post-marketing surveillance in Indonesia? 

A: The key requirements for class III post-marketing surveillance in Indonesia involves adverse event reporting, periodic safety update report, device traceability and recall and plan for PMS. 

5. Do you need a license to sell medical equipment in Indonesia? 

A: Yes, you need a license to sell medical equipment in Indonesia which is usually valid for 5 years after that of which you need to renew it.