Indonesia's Ministry of Health (MOH) generally requires medical devices to undergo label review to ensure their safety, quality, and compliance. Label reviews are part of the medical device registration and licensing process to ensure that product labels contain the necessary information to protect the health and safety of patients and users. Here are some key information about medical device label review:
Compliance requirementsMOH requires medical device manufacturers to provide specific information on product labels to ensure that patients, physicians, and users are able to use the device correctly and understand the potential risks and precautions. This information typically includes product name, model number, lot number, manufacturer information, instructions for use, warnings, intended use, and indications, among others.
Safety and efficacy: Label reviews are designed to ensure that the label of a medical device contains accurate information about its safety and efficacy. This helps patients and medical professionals to use medical devices correctly and reduces the risk of improper use.
Regulatory Compliance: Medical device labels must comply with Indonesian regulations and standards to ensure the legality and compliance of the product. MOH reviews labels to ensure they meet the requirements of local regulations.
Review process: Label review typically involves submitting a product label to MOH for review. MOH will check that the information on the label is complete, accurate and legible and that the label meets the requirements of the regulations.
Notice of ChangeIf a manufacturer decides to change the labeling of a medical device, it is usually necessary to notify MOH in advance and submit information about the change. MOH will review the changes and decide whether to accept them.
International standards: During the label design and review process, manufacturers often need to refer to international standards, such as ISO 15223-1 (identification of medical device labels) and ISO 9809 (content and structure of medical device labels), to ensure label compliance.
Label review is a critical step in ensuring that medical devices are legally marketed and used correctly. By providing detailed and accurate labeling information, manufacturers help medical professionals and patients understand and use medical devices correctly, thereby reducing the risk of improper or unsafe use. MOH's label review helps ensure the compliance and quality of medical devices and protects the rights and interests of patients and users. If you plan to sell medical devices in Indonesia, it is recommended that you contact the Ministry of Health before your product is marketed to understand the latest label review requirements and procedures.