A factory audit is often required during the registration process for medical devices in Indonesia as part of ensuring that the medical device manufacturer's production facilities and quality management system comply with the regulations and standards of the Indonesian Ministry of Health (MOH) and the medical device regulatory body. Here are some important information about the medical device registration pilot factory:
Purpose of the audit: The purpose of the audit is to verify that the production facilities and quality management system of the medical device manufacturer comply with international standards and the regulatory requirements of the Indonesian Ministry of Health. Through factory audits, regulators can ensure that the manufacturing process of medical devices is traceable, controllable, and stable to ensure the quality, safety, and effectiveness of medical devices.
Audit procedures: The audit process is usually carried out by the medical device regulatory agency in Indonesia or a third-party auditor commissioned by it. These procedures may include the following steps:
Notify the manufacturer in advance: The auditor will usually inform the manufacturer in advance of the planned audit so that the manufacturer can prepare.
On-site audit: Auditors visit the manufacturer's production facility to conduct a detailed review of the production process, quality management system, documentation, etc.
Document Audit: In addition to the on-site audit, the auditor also reviews the manufacturer's documents, such as quality manuals, procedure documents, audit records, training records, etc.
Report Preparation: Auditors prepare a factory audit report documenting their findings and recommendations.
Follow-up: Depending on the results of the audit, the manufacturer may need to take corrective action to meet the approval requirements.
Frequency of audits: Audits are often not just a one-time process, but need to be done on a regular basis. Manufacturers are required to undergo regular audits to ensure that their production facilities and quality management systems continue to meet requirements. The frequency of audits may vary depending on the risk level of the medical device and the policy of the regulatory body.
Audits for foreign manufacturers: For foreign manufacturers, their production facilities are also subject to audits by Indonesian regulators to ensure that their medical devices are compliant in the Indonesian market. This can be done through a Ministry of Health Registration** Agency or other designated review body.
Audits of high-risk medical devices: High-risk medical devices, such as implantable medical devices, are often subject to more rigorous and detailed audits to ensure their safety and efficacy. This may involve more on-site audits and technical assessments.
In general, medical device registration in Indonesia usually requires a factory audit to ensure that the manufacturer's production facilities and quality management system comply with regulations and standards. This is to ensure the quality and safety of medical devices. Manufacturers need to work closely together, undergo factory audits, and take the necessary corrective actions to ensure that their medical devices can be legally sold and used in the Indonesian market. The frequency and procedure of a factory audit may vary depending on the classification of the medical device, the risk level, and regulatory policies.