CDAKB Certification Process: Essential Steps for Medical Device Distributors

CDAKB certification is critical in the medical device distribution industry, as it ensures the safe handling, storage, and transport of medical devices. Issued by Indonesia’s Ministry of Health, CDAKB certification is mandatory to meet Good Medical Device Distribution Practices standards.

This article will cover what Good Medical Device Distribution Practices entail, who they apply to, the certification process, and why implementing these standards is essential for medical device businesses.

Understanding CDAKB Certification in Indonesia

CDAKB (Cara Distribusi Alat Kesehatan yang Baik) is the same as Good Medical Device Distribution Practices (GDP), which aims to maintain quality control and ensure that medical devices reach consumers optimally.

According to Article 319 of Health Law No. 17 of 2023, along with Article 416 of Government Regulation No. 28 of 2024 and Article 2, Paragraph (1) of Minister of Health Regulation No. 4 of 2014 on Good Distribution Practices for Medical Devices, all medical device distributors and their branches are required to implement Good Distribution Practices for Medical Devices in all distribution activities.

Medical device registration in Indonesia requires strict compliance to guarantee that devices remain safe and effective for end-users. Violating CDAKB requirements can lead to severe penalties, including up to 15 years of imprisonment or fines of up to IDR 1,500,000,000.

Key Components of CDAKB for Medical Devices

Good Medical Device Distribution Practices requirements cover several aspects of distribution practices to ensure that products meet safety and quality standards when they reach consumers. Here are the primary components:

• Quality Management Systems (QMS): A strong QMS is essential for Good Medical Device Distribution Practices under CDAKB. It ensures that processes are controlled, monitored, and documented throughout medical device distribution.
• Storage and Handling: Proper handling is critical to maintaining device quality. Distributors must follow specific handling guidelines based on each medical device’s characteristics to ensure safety and efficacy.
• Traceability and Record-Keeping: Ensuring the traceability of medical devices through accurate records is essential in medical device distribution.
• Distribution Process Control: Control of transportation and storage processes is crucial to preserving medical devices’ quality through Good Medical Device Distribution Practices.

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Compliance Requirements and CDAKB Certification

Obtaining a CDAKB certificate involves a rigorous medical device registration process, which includes preparing documents, submitting the application, and undergoing an on-site audit.

The Good Medical Device Distribution Practices certification process ensures that medical devices distributed in Indonesia meet all standards set by the Ministry of Health. Non-compliance can result in costly setbacks, so a thorough understanding of the requirements is crucial.

Who Needs CDAKB Certification?

All medical device distributors and their branches in Indonesia must comply with CDAKB regulations to distribute medical devices legally.

Basic Requirements for CDAKB Certification

• Company Profile (e.g., KBLI, location, product type)
• Business Flow of Medical Device Distribution

The Process for CDAKB Certification

The steps involved in obtaining Good Medical Device Distribution Practices certification include:

• Gap Assessment
• Document Collection and Preparation
• Application Submission and Payment
• Document Review by the Ministry of Health
• On-site Audit by the Ministry of Health
• Corrective and Preventive Actions (CAPA) Submission
• Certificate Issuance

Timeline and Additional Service

The certification process for Good Medical Device Distribution Practices (CDAKB) typically takes about 3-4 months from submitting complete and accurate documents, provided there are no regulatory changes or system delays.

• Additional Services:
  • The Electronic Report Submission to the Ministry of Health is a necessary component of the CDAKB application. This report covers health product data from the past six months and is required for compliance.
  • The electronic report’s processing may take 5-20 working days, depending on the volume of data involved.
  • The associated fee for the electronic report is calculated based on the health product data submitted for the last six months.

Benefits of Implementing CDAKB Standards

Following Good Medical Device Distribution Practices standards brings several advantages to distributors, including:

• Increased Credibility and Consumer Trust: Compliance demonstrates a commitment to safety and quality, strengthening relationships with healthcare providers and customers.
• Enhanced Product Safety: CDAKB compliance ensures that medical devices are delivered safely, aligning with Good Medical Device Distribution Practices.
• Regulatory Compliance: CDAKB certification guarantees that medical device distribution processes align with health regulations, reducing the risk of penalties and enhancing company credibility.

Challenges in Implementing CDAKB and How to Overcome Them

Implementing CDAKB can be challenging, particularly for smaller companies entering medical device distribution. Addressing challenges such as high compliance costs, complex regulatory requirements, and logistical issues. However, these challenges can be managed by:

• Conducting a gap assessment to identify areas for improvement before formal audits.
• Investing in staff training on quality control and compliance procedures.
• Working with consulting services specializing in CDAKB to streamline the process.

Obtain CDAKB Certification with InCorp

Adopting CDAKB standards is essential for companies in medical device distribution in Indonesia. This certification aligns with Good Medical Device Distribution Practices and supports patient safety and regulatory compliance, ensuring medical devices reach consumers reliably and effectively.

How InCorp Indonesia Can Assist You:

• CDAKB Certification: We provide comprehensive support throughout the entire CDAKB certification process.
• Medical Device Registration: Our team is well-versed in the regulatory landscape and can help you navigate the complexities of medical device registration.
• Product Registrations: InCorp Indonesia also offers services for various product registrations, including food and beverage registration, health supplements, BPOM registration, and more.

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