Medical device Registration Process In Indonesia

After the initiation of universal health care for their citizens in 2014 by the Indonesian government, the growth of the medical devices market improved and led to the rise in medical devices import. Medical device registration in Indonesia is a relatively fast and inexpensive process, particularly considering the size of the country.

Medical device registration process in Indonesia

Highlights of Indonesia medical device market

Indonesia relies on medical devices and supplies import to meet local demand.
Hypertension, diabetes, stroke, arthritis, cardiovascular issues, and other chronic diseases have immense demands for medical devices and healthcare products in Indonesia.
Most of the imported medical devices are sophisticated equipment such as lasers, CT scans, and other diagnostic equipment, while the basic medical equipment is produced locally.
The CAGR of medical devices is at 16.7% for 2013-2018.
The total value of imported medical devices was estimated to reach IDR 28.4 trillion (USD 2,030 million) in 2018.
For the personal care segment concerning the healthcare sector, the revenue amounts to IDR 6.3 trillion (USD 450 million), with an annual growth rate of 14.9 percent, resulting in a market volume of IDR 11 trillion (USD 785 million) in 2022.

Regulatory authority

The National Agency of Drug and Food Control (NADFC) under the Indonesian Ministry of Health (MoH) regulates medical devices. The authority is also in charge of pre-market and post-market evaluation, standardization, legislation, and Good Manufacturing Practices (GMP) certification.

Medical Devices and IVDs must receive a registration number and product license (AKA marketing license) issued by the Ministry of Health to a local, licensed distributor before import.

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New adapted practices for medical devices in Indonesia

Common Submission Dossier Template CSDT
ISO 13485 for Quality Management System
Good Distribution Practice (GDP)
Post-market Surveillance System
International Standard and Indonesia National Standard to ensure the safety, quality, and effectiveness of medical devices.

Indonesia has introduced eSystems for various processes to make things simple and easy. The following services provided by the online system includes

eProduction License
eRegistration
eINSW
eDistributors License
eDistributors
ePlanning

Medical device in Indonesia

The Ministry of Health of the Republic of Indonesia stated: “medical device” as shall any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material, or another similar or related article. However, devices that contain pharmaceuticals are not considered medical devices.

Local representative

The Indonesian regulations require the manufacturers to appoint a local representative with a Distributor License. A distributor can be appointed to represent the foreign manufacturer in Indonesia. However, appointing an independent third party would provide flexibility to change distributors or appoint multiple distributors for better market penetration.

Classification of medical devices in Indonesia

Class	Risk level	Example
A	Low risk	Surgical Instruments, bandages, electric operating tables, etc.
B	Low-Moderate risk	Pregnancy self-testing kits, electric hospital beds, Surgical Lamps, surgical masks, etc.
C	Moderate-High risk	Blood glucose self-testing kits, ECG, Xray Units, Syringes, etc.
D	High risk	HIV Blood donor screening, stents, Intraocular lens, defibrillator, Pacemakers, etc.

Medical device registration process

To register a medical device in Indonesia, you are required to submit an online application with the following documents:

Company Documents such as Single Business Identity Number (NIB), Company’s Tax ID (NPWP), Trade Business License (SIUP), etc.
Administrative Documents such as Letter of Authorization (LoA), Free Sales Certificate, GMP Certificate/ISO
Technical Documents: Dossier from Manufacturer

The Local Representative must create an account in the online portal. The registration process is the same for all the device classes. However, the documentation required varies with the class of device. The registration is a two stages process –

Pre-Registration process
Evaluation Process

MoH verifies the classification of the device and determines the cost of the evaluation. The result of pre-registration along with the invoice is emailed to the applicant. The local representative, on behalf of the manufacturer, shall make the payment and upload the proof of payment. MoH will review the documents and share the results through email to the applicant. Some devices require In-country testing at an accredited Laboratory.

Approval timelines

Class of Device	Classification Process (Days)	Evaluation Process (Days)
Class A	7	45
Class B	7	90
Class C	7	100
Class D	7	120

Foreign manufacturers

Currently, only local (Indonesian) companies can apply for the SDAK/MDDC. Foreign manufacturers, therefore, have three (3) possibilities to obtain an SDAK/MDDC and so register their medical device in Indonesia:

Post-marketing

Monitoring is conducted according to the ASEAN AMDD Guideline to ensure Quality. After the launching of the product, it remains under the control of charges.

Distribution of medical device

The approved medical devices can be distributed on the following conditions

The company that has the Distribution license (IPAK) issued by MOH RI.
Import Products must have only one legal importer and distributor in Indonesia.

The sponsors shall follow the Good Distribution Practice by conducting a Periodic Audit to assess compliance of all Distributors by MOH RI.

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