The GDPMD, or Good Distribution of Medical Devices, is a set of guidelines used in various activities related to the distribution and quality control of medical devices. Its goal is to ensure that medical device products meet the requirements for their intended use. GDPMD is closely related to ISO 9001, an international standard that focuses on quality management systems and lays out general requirements for organizations seeking to ensure the quality of their products or services. Although GDPMD and ISO 9001 are distinct standards, they both play a key role in quality management within the medical device distribution sector. The regulations governing GDPMD standards are detailed in Minister of Health Regulation Number 14 of 2021, which covers the standards, requirements, and procedures for conformity assessment for GDPMD certification. This regulation encompasses various types of medical devices, including radiation electromedicine, non-radiation electromedicine, sterile and non-sterile medical devices, and in-vitro diagnostic medical devices.

On May 19, 2024, the Ministry of Health of the Republic of Indonesia (Kemenkes RI) issued Circular Letter FR.03.01/E/884/2024 from the Director General of Farmalkes. This circular contains the mandatory requirements for GDPMD certificates in product approval for medical devices, which will be effective from July 1, 2024. The Ministry of Health hopes that this implementation will ensure the quality of medical equipment distributed in Indonesia, protect against substandard and fake medical equipment, and guarantee after-sales services to maintain the standards, safety, quality, and benefits of the medical equipment. Companies involved in medical device distribution are required to promptly implement GDPMD within a short period of time.

DeRay Indonesia is a company that specializes in Regulatory Compliance Consulting. We handle product registration for Medical Devices, IVDs, and PKRT (Household Health Supplies) at agencies such as the Ministry of Health. With over a decade of experience since 2010, we provide professional assistance for local and imported product registration. Our services focus on helping companies obtain product licensing, streamline interactions, navigate the health device registration system with high compliance standards, and ensure swift approval processes.

The CDAKB Project includes SOPs for 13 clauses, including quality management systems, management of resources, buildings and facilities, storage and handling of inventory, product traceability, handling customer complaints, field safety correction actions (FSCA), return of medical devices, destruction of medical devices, illegal and non-compliant medical devices, internal audits, management reviews, and outsourcing activities. We assist our clients in obtaining CDAKB certificates by the Indonesian Ministry of Health.

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