Answer: Registration requires comprehensive product information, including technical specifications, safety and efficacy data, compliance with Good Manufacturing Practice (GMP), and alignment with standards set by the Ministry of Health (Kemenkes) and BPOM. We manage document submission to ensure full compliance.

Answer: We handle the entire compliance process, including documentation review, compliance assessments, and communication with regulatory authorities. This minimizes the complexities clients face and ensures faster, more efficient regulatory approvals.

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For medical devices, regulatory processing typically spans 3-4 months, while cosmetics may take around 3 months. However, timelines vary based on product complexity and classification. We help expedite this by ensuring that documentation is complete and accurate from the start.

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With over 8 years in regulatory affairs for medical devices and cosmetics, we provide insights that help clients avoid common pitfalls, keep pace with industry standards, and streamline approvals for faster market entry.

Answer: To begin, clients can contact us via WhatsApp or our website for a consultation. We conduct an initial compli ance assessment to determine a tailored regulatory approach based on the client’s product specifications.

Answer: We specialize in regulatory services for the medical device and cosmetics industries, supporting manufacturers, importers, and distributors in navigating compliance requirements for Indonesia. 

Answer: We monitor regulatory updates from BPOM and Kemenkes and provide our clients with regular updates on relevant changes. This proactive approach helps clients adjust their compliance processes to remain aligned with the latest standards and avoid potential regulatory issues.

Answer: Yes, we offer solutions tailored to the product type and client needs, ensuring that every compliance requirement is met efficiently and accurately.

Answer: We adhere to strict confidentiality protocols, including data protection and secure handling practices, to safeguard all client information and ensure compliance with Indonesian privacy regulations.

Answer: Common errors include incomplete documentation, misinterpretation of regulations, and underestimating the time required for approval. We work closely with clients to prevent these issues through comprehensive support and guidance.

Answer: Costs vary depending on the product’s classification and the services required. We provide a detailed quote based on an initial consultation, ensuring transparency and a tailored approach to client needs.

Answer: If a product fails to meet regulatory standards, additional documentation may be required. We assess compliance gaps and provide guidance on corrective actions to bring the product into alignment with regulatory requirements.

Answer: Our team conducts a comprehensive pre-registration assessment, which includes evaluating the product’s regulatory classification, labeling, formulation compliance, and necessary documentation. This assessment ensures that potential compliance issues are identified and resolved early, streamlining the registration process.

Answer: IDAK certification ensures that medical devices meet quality and safety standards required for legal distribution, protecting both distributors and end-users by ensuring that only compliant devices reach the market.

Answer: We provide expert review and submission services for regulatory documentation, ensuring each document meets BPOM and Kemenkes standards. Our team verifies compliance with regulatory requirements, helping streamline the registration process by addressing potential issues before submission.

Answer: Yes, we support a wide range of devices, including high-risk and innovative products, ensuring compliance with the latest standards and regulatory updates.

Answer: The IDAK process includes verifying that the distribution warehouse meets quality and safety standards, conducting necessary facility inspections, and submitting required certifications. Our team manages each phase to secure timely and successful certification.

Answer: Medical devices distributed under CDAKB standards must adhere to strict storage and handling protocols, including controlled temperature environments, secure warehousing, and documented procedures for distribution. These requirements are essential to maintain product integrity and comply with Good Distribution Practices.

Answer: CDAKB certification requires a comprehensive quality management system that includes proper storage conditions, accurate record-keeping, and a trained workforce. The distribution facility must also pass routine inspections to ensure adherence to Good Distribution Practices, minimizing the risk of product degradation and contamination.

Answer: CDAKB-certified facilities are typically required to undergo inspections annually to verify ongoing compliance with Good Distribution Practices. These inspections review storage, handling, and transportation procedures to ensure that all regulatory standards are consistently met, safeguarding product quality.

Answer: Importing cosmetics necessitates SKI (Import Certificate) and LS (Surveyor Report) documents that meet BPOM standards. We assist in preparing and submitting these documents to ensure compliant and efficient importation.

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In general, product registrations or licenses have different renewal requirements depending on the type of product:

1. Medical Devices: Typically, licenses need renewal every five years. However, this can depend on the Letter of Authorization (LOA), which must have a minimum validity of two years from the agreement with the principal or manufacturer.
2. Cosmetic Products: Licenses for cosmetic products generally require renewal every three years.

Answer: Non-compliance can result in penalties, including fines, product recalls, or suspension of distribution. We maintain ongoing compliance checks to prevent such risks.

Answer: As a Product License Holder, we assume legal responsibility for the regulatory compliance and distribution of medical devices on behalf of our clients. Our services include product registration, compliance monitoring, and handling importation, enabling clients to enter the Indonesian market without establishing a local entity.

Answer: For cosmetics, we manage the entire regulatory process, including BPOM registration and ongoing compliance. This allows our clients to legally market their products in Indonesia while ensuring adherence to local regulatory obligations.

Answer: While our current focus is on regulatory compliance for medical devices and cosmetics, we continually assess opportunities to expand our expertise. As regulations evolve and new industries emerge, we may offer services in other sectors to meet the growing needs of our clients.