Medical Product Registration Malaysia

General Medical Device - Medical Device Authority (MDA)

https://portal.mda.gov.my/industry/medical-device-registration/general-medical-device.html

Medical Device Registration. General Medical Device; In-Vitro Diaganostic Device; Change Notification; Combination Product; Withdrawal or Cancellation; Conditional Approval for Covid19 RTK …

Malaysia Medical Device Registration - MDA Approval

https://www.pacificbridgemedical.com/regulatory-services/medical-device/product-registration/malaysia/

Yes, medical devices do require registration before they can be sold in Malaysia. Starting on July 1, 2016, Malaysia’s Medical Device Act has made it mandatory for all foreign manufacturers to register their …

Official Portal of Medical Device Authority (MDA) …

https://www.mda.gov.my/

Semua establismen yang menjalankan aktiviti meletakkan peranti perubatan dalam pasaran perlu mempunyai Lesen Establismen dan peranti perubatan tersebut perlu didaftarkan seperti yang termaktub dalam Akta …

Registration Requirements for Medical Devices in Malaysia

https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/registration-requirements-for-medical-devices-in-malaysia

Product Registration Process - National Pharmaceutical …

https://www.npra.gov.my/index.php/en/product-registration-process.html

Product Registration Process Step 1: Pre-submission of Application (Preparation) Step 2: Submission Step 3: Screening Step 4: Evaluation of Application …

Malaysia medical device registrations | TÜV SÜD Malaysia

https://www.tuvsud.com/en-my/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/registration-requirements-for-medical-devices-in-malaysia

To register a medical device for sale in Malaysia, a manufacturer must retain the services of a conformity assessment body (CAB) licensed by the Medical Device Authority to …

Malaysia Medical Device Registration | Andaman Medical

https://andamanmed.com/regulatory-services/medical-device-registration/malaysia/

Only companies which have an Establishment License can register a medical device in Malaysia. As only local (Malaysian) companies can apply for an Establishment License, …

FAQ : Product Registration - NPRA

https://www.npra.gov.my/index.php/en/component/content/article/37-english/faq/623-product-registration.html?Itemid=1391

All pharmaceutical products must be registered with the Drug Control Authority before it can be marketed in Malaysia. A foreign company wishing to bring …

Re-registration - Medical Device Authority (MDA)

https://www.mda.gov.my/162-medical-device-registration/343-re-registration.html

Medical Device Safety & Performance Complaint; Information and Awareness; Safety Information; Advertisement Approval; Industry. Medical Device Registration. General …

Registration - Malaysian Medical Council (MMC)

https://mmc.gov.my/registration/

Pursuant to the Medical Act 1971, you are required to register with the Malaysian Medical Council (MMC) to practice medicine in Malaysia. Pursuant to Sections 12 (1) (aa) of the Medical Act 1971, the Examination …