ADVERTISEMENT OF MEDICAL DEVICE
Advertisement of Medical Device
The Medical Device (Advertising) Regulations 2019 were approved and published in the Gazette on 15 November 2019. These regulations prescribe the method of control of medical device advertisements under Section 44 of the Medical Devices Act 2012 (Act 737). These Regulations detail out conditions and requirements of the content of medical device advertisement. With the gazettement all these Regulations, any medical device advertisement shall meet all requirements set out in Section 44 of the Medical Device Act (Act 737) and the Medical Device (Advertising) Regulations 2019 and, shall obtain approval from the Medical Device Authority (MDA) before the advertisement is published.
In relation to that, the implementation of the Medical Device (Advertisement) Regulations 2019 has already started on 4 May 2021. An announcement via MDA FB Live had also been made on the same date. From that date, any establishment, advertising agency, or any person who wants to advertise any registered medical device shall apply for advertisement approval from MDA. Full enforcement of these Regulations will commence on 1 January 2022.
To guide any establishment, advertising agency, or any person wishing to advertise any registered medical device, MDA has prepared the following documents—
- MDA/GD/0032: Code of Advertisement (COA) which provides guidance regarding the advertising codes that need to be adhered to in advertising a registered medical device (Link to the document); and
- MDA/GL/04: Guideline Application for Medical Device Advertisement Approval (2nd Edition) – which addressing requirements and procedures to apply for approval of medical device advertisement (Link to the document).
Applications for medical device advertisement approval can be made starting from 4th May 2021 following the application procedures as stated in document MDA/GL/04 and using the Medical Device Advertisement Approval Application form ( Medical Device Advertisement Approval Application form ). A complete application form accompanied with supporting documents and a bank draft for payment of processing fee of RM1000 need to be sent to MDA by hand, post, and courier to the following address;
Medical Device Authority (MDA)
Ministry of Health Malaysia
Level 6, Prima 9, Prima Avenue II
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, Malaysia
Please visit the portal, www.mda.gov.my, or call us at 03-82300300 for more information. Any inquiries can be extended to our feedback management system at https://femes.mda.gov.my. If any party wishes to advice and consultation regarding the application for approval of advertisements and compliance with advertising codes, they may drop an email to email@example.com to set an appointment.
Submission and payment instructions for MEDICAL DEVICE ADVERTISING
A) Form Filling Instruction
Please complete all information requested in this form. Incomplete application will be rejected and returned to the applicant.
Please complete the Checklist form to indicate all documents have been provided and attached together with the application form.
Please send your application in hardcopy by hand, post or courier.
B) Format of the Proposed Advertisement
|1.||The format of the audio or video shall be in .MP3, .MP4 or .AVI.|
|2.||The size of the copy of the advertisement draft to be submitted in the printed form (e.g: advertisement write-up/story board/artwork/script/dialog must shall be not more than 300Mb per document.|
|3.||Unprintable advertisement draft can be stored in any portable storage such as CDR, USB Flash Drive, USB Pen Drive and etc and must be provided together with the application form.|
C) Payment Instruction
|1.||Processing fee shall be paid during submission.|
|2.||All payments shall be made through bank draft. Cash and online payment are NOT accepted. We will not be responsible for the cash sent or brought to our office.|
|3.||The bank draft shall be made payable to "KUMPULAN WANG PIHAK BERKUASA PERANTI PERUBATAN".|
|4.||Information of the name and phone no. of the applicant shall be written at the back of the bank draft.|
|5.||Payment of the processing fee for multiple applications for advertisement CANNOT be combined in one bank draft. Payments shall be split in separate bank drafts according to application.|
|6.||The advertisement approval shall be given only after acceptance of the bank draft.|
|7.||The bank draft will be returned to the applicant if payment information is inaccurate.|
|8.||A receipt of payment will be issued once the bank draft is accepted. The receipt shall be kept as proof of payment.|
|9.||Processing fee is non-refundable regardless of the outcome of the application.|
Updated: 23rd February 2022