Medical Devices Registration: A Guide to Indonesian Market Entry

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GOVERNMENT AUTHORITY

The Ministry of Health (MoH) serves as the key regulatory authority overseeing medical device registration in Indonesia. This encompasses pre-market and post-market evaluation, standardization, legislation, and certification of Good Manufacturing Practices (GMP).

Before importation, medical devices and In Vitro Diagnostics (IVDs) must obtain a registration number and product license, commonly known as a marketing license, from the Ministry of Health. These licenses are issued to local, licensed distributors, ensuring compliance with regulatory standards.

PRODUCT CATEGORIZATION

In Indonesia, the registration process for medical devices is governed by guidelines that align with GHTF Classification standards and are harmonized with the ASEAN Medical Devices Directive. The classification system consists of four classes—A, B, C, and D—categorized according to the level of risk the device poses.

The registration routes for medical devices in Indonesia vary depending on their classification. Manufacturers must navigate these routes accordingly to ensure compliance with regulatory requirements and obtain market authorization for their products.

Class A Medical Device or IVD Device	15 days	US$115 (Indonesia Rupiah 1,500,000)
Class B Medical Device or IVD Device	30 days	US$230 (Indonesian Rupiah 3,000,000)
Class C Medical Device or IVD Device	30 days	US$230 (Indonesian Rupiah 3,000,000)
Class D Medical Device or IVD Device	45 days	US$340 (Indonesian Rupiah 5,000,000)

Understanding the classification of a medical device is crucial, as it determines the appropriate registration route and the level of scrutiny applied during the evaluation process. By adhering to classification guidelines and selecting the correct registration route, manufacturers can streamline the registration process and expedite market entry for their medical devices in Indonesia.

REGULATORY EFFICIENCY

Registering medical devices in Indonesia is a streamlined and cost-effective process, given the country’s vast size. Before importing, medical and IVD devices must obtain a registration number and product license, also known as a marketing license, from the Ministry of Health (MoH). This is facilitated through a licensed importer, who acts as the license holder.

MEDICAL DEVICE STATUS

Medical devices registration in Indonesia encompasses instruments, devices, and apparatus utilized for diagnosing, preventing, monitoring, treating, or alleviating illnesses. It’s essential to note that devices containing pharmaceuticals do not fall under the medical devices category in Indonesia.

DOCUMENTS REQUIRED FOR INDONESIA MEDICAL DEVICE REGISTRATION

To initiate the medical devices registration process in Indonesia, applicants must adhere to specific requirements outlined in the local registration form, which closely resembles the ASEAN Common Submission Dossier Template (CSDT).

The ASEAN CSDT encompasses various essential components, including:

Executive Summary: A concise overview of the medical device and its intended use.
Device Labelling/IFU: Details regarding device labelling and instructions for use.
Detailed Manufacturer Information: Comprehensive information about the manufacturer, including contact details and manufacturing processes.
Summary of Design Verification and Validation Documents: An overview of documents confirming the device’s design and validation processes.
Risk Analysis: Evaluation of potential risks associated with the device and mitigation strategies.
Quality Management Certification (ISO 13485): Certification indicating compliance with international quality management standards.
Clinical Evaluation Report: Assessment of clinical data supporting the device’s safety and efficacy.
Free Sales Certificate: Documentation demonstrating that the device is freely sold in the manufacturer’s country of origin.
Risk Management Report: Documentation outlining the device’s risk management plan.
Flow Manufacturing Process: Description of the manufacturing process flow for the device.
Raw Materials Used: Details regarding the raw materials utilized in device manufacturing.
Design Verification and Validation or Sterilization Validation: Validation reports confirm the device’s design and sterilization processes.
Biocompatibility: Evaluation of the device’s biocompatibility with biological systems.
Declaration of Conformity: Declaration confirming compliance with relevant regulatory standards.
Letter of Confirmation for Market History Proof from Manufacturer: Confirmation of the device’s market history from the manufacturer.
Letter of Authorization: Authorization letter allowing the submission of the registration application on behalf of the manufacturer.
Good Distribution Practice for Medical Devices (GDPMD): Compliance with Good Distribution Practice for Medical Devices (GDPMD) is essential to ensure that the medical devices are consistently handled, stored, and distributed according to regulatory requirements. This includes maintaining device integrity and traceability throughout the supply chain.

By meticulously compiling and submitting these documents as part of the registration process, applicants can navigate the regulatory requirements and obtain approval for medical device registration in Indonesia.

VALIDITY AND RENEWAL

Aspect	Details
Validity Period	Product licenses in Indonesia typically last for two to five years, based on Letter of Authorization validity.
Amendments	Amendments to existing licenses can be made for changes in packaging, labeling, and other specified details, as per Indonesian regulation (Decree of Ministry of Health No. 62 /2017; article no. 30).
Renewal Fee	The renewal fee is US$75 (Indonesia Rupiah 1,000,000).
Amendment & Renewal Fee	The combined fee for amendment and renewal is IDR 1,500,000, while individual renewal or amendment costs IDR 1,000,000.
Processing Time	Amendment and renewal processes typically take 10-15 working days.
License Transferability	Licenses are non-transferable, with only one valid per device at a time.
License Termination	Manufacturers have the option to unilaterally terminate licenses, subject to a 6-month reapplication period.

LICENSE HOLDER REQUIREMENTS

To initiate the medical devices registration process in Indonesia, a Sole Importer is required. This role is fulfilled by a local agent who submits the application and holds the necessary license. The agent is granted power of attorney to manage the registration license on behalf of the foreign manufacturer. Moreover, the licensee plays a crucial role in the importation process, ensuring compliance with regulatory requirements throughout.