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INDONESIA MEDICAL DEVICE REGISTRATION
The primary government agency responsible for regulation of medical devices in Indonesia is the Ministry of Health (MoH). The authority is also in charge of pre-market and post market evaluation, standardization, legislation and Good Manufacturing Practices (GMP) certification. Prior to importation, 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.
Medical Device registration in Indonesia is a relatively fast and inexpensive process particularly considering the size of the country. Prior to importation, medical and IVD devices must receive a registration number and product license (AKA marketing license) issued by the MoH to a local, licensed importer (license holder).
Medical Device Status
Instruments, devices and apparatus that diagnose, prevent, monitor, treat or reduce illness are considered Medical Devices in Indonesia. Devices that contain pharmaceuticals are not considered medical devices.
Medical device classification in Indonesia closely follows GHTF Classification guidelines and are being harmonized according to the ASEAN Medical Devices Directive with four classes A, B, C and D, ranked from low to high risk categorization. The registration routes vary based on the classification of the device:
|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)|
Medical Device or IVD Device
|30 days||US$230 (Indonesian Rupiah 3,000,000)|
D Medical Device or IVD Device
|45 days||US$340 (Indonesian Rupiah 5,000,000)|
Registration applications must be submitted as ASEAN Common Submission Dossier Template (CSDT).
Australia – Canada – European Union – Japan – United States
Medical device registration includes administrative documents such as a device labeling, device description, including, features, intended use, indications, instructions for use, contraindications, warnings, precautions, potential adverse effects, and other relevant specifications. Some devices may require documentation of pre-clinical studies and risk analysis assessments.
Note that Marketing Licenses are limited to 500 parts, before being split into two applications / AKL licenses.
Quality Systems Conformity Assessment
Medical device registration requires ISO 13485 certificates to certify the quality system/s of the legal and/or actual manufacturing facilities.
Validity and Renewal
Product licenses are valid for two to five years, depending on the validity period of the Letter of Authorization. Indonesian regulation (Decree of Ministry of Health No. 62 /2017; article no. 30) provides for amending an existing product license to account for changes in the packaging dimension, packaging size, labeling, and tax ID number. All other product changes would require a new registration submission.
The renewal fee is US$75 (Indonesia Rupiah 1,000,000).
Licenses are non-transferable, and only one can be valid per device at one time.Under new regulations, manufacturers can unilaterally terminate their license (in situations with uncooperative distributors) but will need to wait 6 months before reapplying.
License Holder Requirements
Medical Device registration requires a Sole Importer. A Local agent must submit the application and hold the license. An agent is granted power of attorney to hold the registration license on behalf of a foreign manufacturer. Additionally, the License Holder must be involved in the importation process.
To transfer a valid product license from one local agent to another requires that the original license be cancelled, and a new application filed. The process is uncomplicated but does require the full cooperation of the original license holder. If the license holder is not cooperative and refuses to give up the Letter of Authorization, the MOH mandates a 6-month waiting period before manufacturers can reapply.
Benefits of Independent License Holder
- Sell directly to multiple regional distributors, avoiding mark-up by a national importer
- Increase transfer pricing
- Improve leverage in distributor negotiations/responses
- Add or change distributors as required
- Keep intellectual property away from local commercial agents
- The e-Catalogue system also increases the importance of independent license holding in Indonesia because there is no room for regional-dealer margin under the price scheme.
Contact Asia Actual for assistance with medical device regulations in Indonesia
Indonesia Regulatory Support
Ilham’s Regulatory Hint
“Products that enter, distribute and sell within the territory of Indonesia must be halal certified.”
US: +1 512 898-9222
Latest Market Updates
- Indonesia Freezes Government Purchases of 79 Categories of Imported Medical DevicesJuly 7, 2021 - 3:02 pm
- COVID Test Kits Now Require In-Country Testing in the Philippines and IndonesiaMay 4, 2021 - 4:54 pm
- Indonesia e-Catalogue to Soon Open for 1,480 Medical Device CategoriesDecember 8, 2020 - 5:14 pm
- Indonesia Market Summary and Registered Devices ReviewOctober 23, 2020 - 7:15 pm
- INDONESIA E-CATALOGUE MEDICAL DEVICE ENROLLMENT 2020June 30, 2020 - 3:57 pm