To import, distribute, and supply medical devices in the Malaysia market, compliance with the requirements of the Medical Device Act 2012 (Act 737), including medical device registration, is required.
However, if medical devices need to be imported and re-exported for purposes such as maintenance, testing, sterilization, packaging, labeling, distribution hurbs, or other purposes designated by the importer, the registration requirements under the relevant laws are waived. In such cases, the importation and re-exportation of medical devices are permitted through an “IRE(Importation of medical device for Re-Export) approval” letter issued by the authorities before importing the medical devices for re-export.
The guidelines include the procedures and requirements for applying for IRE approval, the conditions for approval, and the post-importation requirements.
When applying for IRE approval, the applicant must confirm whether the product is a medical device, and only if it is a medical device can the application be submitted for approval. Additionally, the applicant must be a registered company in Malaysia, an authorized facility, or a local agent responsible for the importation of medical devices.
The IRE application must be submitted at least 21 days before the intended import date, and the review period is approximately 14 days. After receiving IRE approval, the validity period is 12 months. To extend the validity period, an extension application must be submitted at least 14 working days before the expiration date, and the validity can be extended for up to 6 months from the initial expiration date.
After receiving IRE approval, the importer must maintain records and report to the MDA on a quarterly basis. The medical devices must be re-exported before the IRE approval letter expires.
Please refer to the attached document below.
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