Kuala Lumpur Kepong Berhad KLK is a company incorporated in Malaysia and listed on the Main Market of Bursa Malaysia Securities Berhad with a market capitalisation of approximately RM21687 billion at the end of September 2021. Medical Device Authority MDA Ministry of Health.
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Classes I IIa IIb and III.
. Medical Device Authority MDA Ministry of Health Malaysia Level 6 Prima 9 Prima Avenue II Block 3547 Persiaran APEC 63000 Cyberjaya Selangor MALAYSIA 603 - 8230 0300 603 - 8230 0200. And If you are reporting a Medical Device Recall select Recall -Mandatory Problem Reporting Field. Under the new regulations Registration Holders can authorize an unlimited number of distributors to import under the MA License as well as participate in public tenders.
LOCAL FEES New Application. Optimal display using. Local testing is required for devices that are listed in Annex 1 of MDS G29.
Medical Device Listing in Medical Device National Registry MDNR. Medical device manufacturers must appoint and grant Power-of-Attorney to a local registered company in Vietnam to submit registration applications and act as the Registration Holder. Product Notification in Product Tracking System UTS will take approximately 1 week.
Not applicable LOCAL FEES. Block 3547 Persiaran APEC 63000 Cyberjaya Selangor MALAYSIA 603 - 8230 0300 603 - 8230 0200. Up to 2 weeks.
In most cases however the application is waived from local testing. Medical device registration is handled by Turkish Medicines and Medical Devices Agency TITCK CLASSIFICATION. Medical Device Marketing Authorization MDMA.
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