Following the enactment of the One License Per Establishment Role Policy outlined in the “General Directive of the Minister of Health No. 1/2024, in accordance with the provisions of the Medical Device Authority Act 2012 [Act 738]: Implementation of the One License Per Establishment Role Policy,” the Medical Device Authority (MDA) of Malaysia has declared that as of July 1, 2024, establishments holding multiple roles on their licenses are required to adhere to the following:
- Select one role to retain on the renewable license.
- Remove any other roles and apply for separate licenses.
- New license applications will be accepted for one role only. Renewal applications must specify one role and complete the corresponding Google Form below:
- Role Update Form: https://forms.gle/5386BaPF3WjD7txe7
- Refund Application Form: https://forms.gle/fp5pDtL8Uu1h6Pau7
- Establishment Role Update Form: https://forms.gle/5386BaPF3WjD7txe7
- Refund Application Form (Single License): https://forms.gle/fp5pDtL8Uu1h6Pau7
Please refer to the document at the link provided below regarding the procedures for license renewal: [ARAHAN AM : PELAKSANAAN DASAR SATU LESEN UNTUK SETIAP PERANAN ESTABLISMEN MULAI 1 JULAI 2024]
If you are an Authorized Representative, it is advisable to retain this role to prevent disruptions in medical device registrations, notification changes, and post-market activities.
Please ensure all information provided is accurate and correct. Further information on this regulation can be accessed here PELAKSANAAN DASAR SATU LESEN UNTUK SETIAP PERANAN ESTABLISMEN MULAI 1 JULAI 2024 (mda.gov.my)
For questions about this regulation, contact the Licensing Unit at license-unit@mda.gov.my or speak with a Licensing Unit officer; for further inquiries, reach out to us at sales@andamanmed.com or click the button below.
If you have any queries about this draft guidance, please contact us at sales@andamanmed.com or click the button below.