Medical Product Registration 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 Step 5: Regulatory Outcome Step 6: Post-Registration Process Email: [email protected] …

General Medical Device - Medical Device Authority …

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 …

Malaysia Medical Device Registration

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 …

Official Portal of Medical Device Authority …

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

Official Portal of Medical Device Authority (MDA) Malaysia - Medical Device Authority (MDA) Announcement 1 2 3 4 5 Prev Next NEW RELEASE GUIDELINE DOCUMENT …

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

Registration, Licensing & Enforcement - Registration, …

https://portal.mda.gov.my/faq/registration-licensing-enforcement.html

Do I need to apply for establishment licence, medical device registration or both? All establishments, ie manufacturer, authorised representative (AR), importer and distributor …

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 …

Medical Device Registration in Malaysia - Asia Actual

https://asiaactual.com/malaysia/medical-device-registration/

Medical Device registration applications must be submitted via the on-line MEDCAST system by a licensed, local entity that also acts as license holder, or Malaysia Authorized …

Re-registration - Medical Device Authority (MDA)

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

Suspension and Cancellation of Establishment Licence and Medical Device Registration News All news Safety Information The following documents are summary of some …

Registration - Malaysian Medical Council …

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 …