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.
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.
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
- eDistributors License
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.
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
|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.
|Class of Device||Classification Process (Days)||Evaluation Process (Days)|
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:
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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