Indonesia Medical Device Registration
Healthcare is a priority in Indonesia’s national development agenda. Hence, it presents excellent opportunities for foreign exporters of medical equipment and supplies.Qualtech is your ideal partner to for your foray into the Indonesia medical device market for an easy and smooth registration process.
Qualtech in Indonesia
IPAK Certificate
We are Indonesia Government approved entity to process regulatory and distribution work of medical device. We successfully assisted foreign manufacturers to access local market.
Expert in Non-active Device
We offer clients an efficient registration way for high risk products to open local market in a short time. We have obtained 100 cases approval.
QT Services
Medical Device Registration
Our in – house experts are able to provide you with excellent professional service in preparing customized ASEAN Common Submission Dossier Template (CSDT) and liaise with MoH officers to get your devices registered in the Indonesia.
Authorized Representation
As an in – country authorized representative (AR), Qualtech can hold a medical device registration license on behalf of foreign manufacturers looking to market medical devices in Indonesia. This is in compliance with the law for a local establishment to be a license holder.
Importation
The local distributor you are looking is sometimes not a qualified importer, or is not familiar with the importation process of medical device. Qualtech has extensive experience in importation in many regions of Asia, assisting several customers to handle customs clearance of various medical equipment imports. We can assist your products to be delivered to customers smoothly!
E-katalog Application
We also provide professional guidance and service for local manufacturers, importers, distributors and authorised representatives to apply for an E-katalog License with MoH. Having a team of local consultants who are well-versed in the requirements of local regulations, your journey will be smooth with us.
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Registration with MoH |
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Classification
Class A
Low risk device
Marketing License
Online submission
Class B
Low-Moderate Risk
Marketing License
Online submission
Class C
High-Moderate Risk
Marketing License
Online submission
Class D
High Risk
Marketing License
Online submission
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CLASS A | CLASS B | CLASS C | CLASS D |
|---|---|---|---|---|
| Executive Summary | Yes | Yes | Yes | |
| Essential Principles and Methods | Yes | Yes | Yes | |
| Device Description | Yes | Yes | Yes | Yes |
| Summary of Design V&V | Yes | Yes | Yes | Yes |
| Labeling and IFU | Yes | Yes | Yes | Yes |
| Risk Assessment | Yes | Yes | Yes | |
| Physical Manufacturer Information | Yes | Yes | Yes | Yes |
| Clinical Evidence | Yes | Yes | Yes | |
| PMS Plan and Report | Yes | Yes | Yes |
Note: Kindly see the Pedoman Penilaian Alat Kesehatan Sesuai Dengan Permenkes Nomor 62/2017 issued on 2019 for more details.
Workflow
MoH Target Reviewing Turnaround Time
After successful internal evaluation of the submission dossier, our in – house experts will then submit it to the MoH and will be subjected to thorough evaluation. Below is a list of the turnaround times for different types of transactions involving product registration/notification.
| CLASS A | CLASS B | CLASS C | CLASS D | |
|---|---|---|---|---|
| 1st Evaluation | 15 | 30 | 30 | 45 |
| Compliance | 10 | 10 | 10 | 15 |
| 2nd Evaluation | 10 | 10 | 10 | 10 |
- Note:
- 1. It’s accounted as Working days.
- 2. There is only one opportunity to comply with evaluator’s additional input requests.
Validity
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Types of Certificates: Marketing License
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Marketing License: Depends on validity of LOA, max is 5 years
Tips
Could I Change Distributor?
Some manufacturers might face the poor selling performance in Indonesia, and would like to exchange the sole distributor. We have received several inquiries from our clients or partners in local.
Unfortunately, it’s a hard task to change new local agent in Indonesia because of law restriction – MoH requests the no objection letter from the current local agent. Usually the local authorization representative is unwilling to offer this letter.
To avoid this situation from the sales work in Indonesia, we would suggest put license in 3rd party, such as Qualtech.
For more information, please refer to the MoH’ official website or you may contact us for a free consultation.
Official Website
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MoH Website Homepage
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MoH Product Database
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MoH Regulatory Announcement Board
Recommendation
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