SIRIM Approval Process For Medical Device In Malaysia
The SIRIM approval process for medical devices in Malaysia is designed to ensure the safety and effectiveness of these devices for use in the country. It is important for manufacturers and importers of medical devices to follow the approval process to ensure that their products can be legally sold in Malaysia.
SIRIM is the abbreviation for the Standards and Industrial Research Institute of Malaysia. It is a government-owned company that provides testing, certification, and research and development services in Malaysia.
One of the services offered by SIRIM is the approval process for medical devices in Malaysia.
The SIRIM approval process for medical devices in Malaysia involves the following steps:
Step 1: Classify your medical device
The first step in the approval process is to determine the classification of the medical device. The classification is based on the intended use and the risk associated with the device.
Step 2: Submit documents
The manufacturer or importer of the medical device must submit the required documents such as an application form, technical file, assessment certificate, etc. to SIRIM:
Step 3: Review of documents
SIRIM will review the submitted documents to ensure that the device meets the relevant standards and regulations.
Step 4: Testing
Testing: If required, SIRIM will arrange for the testing of the device at an accredited laboratory.
Step 5: Decision
SIRIM will issue a certificate of conformity if the device is found to be in compliance with the relevant standards and regulations. If the device is not in compliance, SIRIM may request additional information or testing.
Do you have more questions regarding SIRIM approval or registering your medical device in Malaysia?
Do you need support classifying and/or registering your medical device in Malaysia? Email your requirements to inquiry@credevo.com to connect with us.
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