KEMENKES
BPOM
FOOD/BEVERAGE
HEALTH SUPPLEMENT
IDAK
PSB
IMPORT CLEARANCE
Indonesia Regulatory Service
Embarking on the regulatory journey in Indonesia can be intricate and demanding, given its complex nature. At InSightOf Consulting Indonesia, our expertise in regulatory services streamlines this process, providing invaluable assistance in obtaining approvals for medical device registrations and upcoming pharmaceutical products. We simplify the entire journey, guiding you seamlessly through preclinical testing, approval acquisition, and market entry, ensuring a hassle-free experience for your business.
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), We 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. We have 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.
Classification
Class A
Class B
Class C
Class D
| TECHNICAL REQUIREMENTS | 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 |
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
* It’s accounted as Working days.
* There is only one opportunity to comply with evaluator’s additional input requests.
* In some cases, the government institution may request additional documents during the registration process. Such a request would have an impact on the timeline and could prolong registration process
| MoH Target Reviewing Turnaround Time | CLASS A | CLASS B | CLASS C | CLASS D |
|---|---|---|---|---|
| 1st Evaluation | 15 days | 30 days | 30 days | 45 days |
| Compliance | 10 days | 10 days | 10 days | 15 days |
| 2st Evaluation | 10 days | 10 days | 10 days | 10 days |
on a working - day basis
Q&A
1. What documents are required for registering medical devices and cosmetics in Indonesia?
Clients need to provide detailed product information, safety and efficacy data, manufacturing processes, and compliance with standards set by the Ministry of Health (Kemenkes) and BPOM. We assist in preparing and submitting these documents to ensure compliance.
2. How can INSIGHTOF Consulting Indonesia help with the complexities of regulatory compliance?
We simplify the regulatory process by providing expert guidance, managing documentation, and liaising with regulatory bodies, saving our clients time and effort while ensuring compliance.
3. What challenges might clients face during the regulatory approval process?
Clients may encounter challenges such as complex documentation requirements, strict regulatory standards, and lengthy approval times. Our expertise helps navigate these challenges efficiently.
4. How long does it typically take to complete the regulatory process?
The duration can vary based on product complexity and regulatory requirements. We strive to expedite the process by efficiently managing documentation and communications with regulatory authorities.
5. What experience does INSIGHTOF Consulting Indonesia bring to the table?
We have a broad of experience in regulatory affairs for medical devices and cosmetics, for more than 5 years, enabling us to provide expert guidance and support throughout the compliance process, ensuring smooth and efficient approvals.
6. How can clients begin the regulatory process with INSIGHTOF Consulting Indonesia?
Clients can start by contacting us through our contact number or email or website. Our team will provide an initial consultation to understand their needs and develop a tailored plan to meet regulatory requirements.
7. What industries do you serve with your regulatory services?
We primarily serve the medical device and cosmetics industries, helping manufacturers, distributors, and importers navigate regulatory compliance in Indonesia.
8. Can INSIGHTOF Consulting Indonesia assist with local regulatory compliance outside of Indonesia?
We specialize exclusively in Indonesian regulatory compliance for medical devices and cosmetics, ensuring our clients meet all local standards and requirements effectively.
9. Do you provide customized solutions for regulatory compliance?
Yes, we offer tailored solutions based on the specific needs and products of our clients, ensuring they meet all relevant regulatory requirements and standards.
10. How does INSIGHTOF Consulting Indonesia ensure client confidentiality?
We adhere to strict confidentiality protocols and data protection measures, ensuring that all client information is secure and handled with the utmost care throughout the regulatory process.
11. What are the common pitfalls clients should avoid during the regulatory process?
Common pitfalls include incomplete documentation, misunderstanding regulatory requirements, and underestimating the time needed for approvals. We help clients avoid these issues by providing comprehensive support and expertise.
12. What are the costs associated with regulatory compliance services?
The costs can vary depending on the specific services required and the complexity of the regulatory process. We provide customized quotes based on individual client needs. Contact us for a detailed estimate.
13. What happens if my product does not meet regulatory standards upon product registration process?
If a product does not meet regulatory standards, it may be rejected or require modifications. We help identify and address any issues to ensure your product meets all necessary requirements.
14. What is the first step in the regulatory compliance process?
The first step is to conduct a thorough review of your product and its documentation. We then develop a tailored plan to ensure all regulatory requirements are met and guide you through the entire process.
15. Why is obtaining an IDAK crucial for medical device distributors?
An IDAK (Medical Device Distribution License) is essential for medical device legal distribution in Indonesia, ensuring that devices meet safety and quality standards, which protects both the distributor and the end users.
16. Can you assist with regulatory compliance for new and innovative medical devices?
Yes, we have experience with a wide range of medical devices, including new and innovative products. We stay updated on regulatory changes to provide the best guidance for compliance.
17. What is involved in obtaining an IDAK (Medical Device Distribution License)?
Obtaining an IDAK involves ensuring that your distribution warehouse meets regulatory standards specific to medical devices. This includes having a dedicated service team to manage and maintain the quality and safety of the devices. We assist with the preparation and submission of the necessary documentation to meet these requirements.
18. Do I need a separate registration for each product variant?
Yes, each product variant may require separate registration, depending on differences in formulation, design, or intended use. We can help determine the specific requirements for each variant.
19. How does CDAKB certification benefit medical device distribution?
CDAKB (Certification of Good Distribution Practices) ensures that medical devices are handled and stored according to high standards, reducing risks and maintaining product integrity, which is crucial for client trust and safety.
20. What is involved in obtaining PSB certification for facilities?
PSB (Certification of Facility) involves an inspection to verify that storage and handling conditions meet regulatory standards, ensuring the safety and quality of stored product.
21. What are the steps to import cosmetics into Indonesia?
Clients need to obtain SKI (Surat Keterangan Impor) and LS (Letter of Statement) documents. We assist in preparing these documents and ensuring they meet BPOM requirements for legal importation.
22. How often do I need to renew my product registration or licenses?
Renewal periods can vary depending on the type of product and regulatory requirements. Typically, registrations and licenses need to be renewed every few years. We provide reminders and assistance with renewals.
23. What are the penalties for non-compliance with regulatory requirements after the product has been registered and distributed?
Non-compliance can result in penalties such as fines, product recalls, or suspension of distribution in accordance to government regulations. We help ensure that your products meet all regulatory requirements to avoid these penalties.