MDA has come up with a new guidance document incorporating the 2019 published Medical Device Advertisement Regulation. This guidance document is to ensure establishments promote medical devices in a socially and ethical manner for a good marketing practice. Advertising includes activities related to information of written or spoken words and any pictorial representation or design which used or appearing to be used to promote the sale of medical devices generally by highlighting the approved device claims.
These guidance documents specified the requirements for the advertisement of medical devices. The responsible person for medical device advertisement is:
- The manufacturer and authorized Representative of the medical device.
- A private individual or a third party assigned by the manufacturer or authorizes the representative to advertise on their behalf,
- A person who advertises a medical device with authorization from the manufacturer or authorized representative.
The establishment shall comply with the code of advertisement (COA) to promotes the standards for ethical advertising. All medical devices registered with MDA each home use or general public use medical device need to apply for advertisement approval. The application shall be submitted by the advertiser to the MDA using the application form provided by the MDA and published on the MDA website at www.mda.gov.my. MDA allows for the same content and media of advertisement to apply for multiple medical devices in one application. However, this not allowable for TV, radio, and Internet advertisement with sound or video recordings. In addition, any changes in the content related to pictorial change with delivering a different message or claim need to submit a new application to MDA.
The below advertisement requires no approval from MDA but must control through self-regulation:
- Catalogs or pamphlets that only contain product pictorial representation, brand and /or company name and/or logo that does not consist of any product claims;
- Materials contain a replica of packaging approved by the Authority; and
- All contain a replica of packaging approved by the Authority
The establishment shall advertise factually correct information and accurate without false or misleading information to avoid ambiguity. It is not allowed to promote a medical device outside its approved claim. Below are some lists of claims that are not allowed to advertise in the advertisement content:
- - Therapeutic claims
- - Relating to aging and premature aging
- - Concerning the brain, memory, and concentration
- - Relating to immunity against specific disease(s)
- - Relating to stress
- - Relating to performance in sports and studies
- - Concerning weight management
- - “Before” and “after” claims
- - Related to device origin
- - Natural claims
- - Device novelty claims
- - Safety claims
This guidance also covers social responsibility in advertising the medical device. All endorsements and testimonials are not allowed to feature without consent from MDA.
On 20th May 2020, MDA published a new policy regarding the transition period for medical device advertisement. In the original plan, this regulation will commence on 1st July 2020. However, MDA decided to extend the implementation date until 31st December 2021, an additional transitional period of another 18 months. Thus, with the new policy, the establishment needs fully comply with the regulation by the end of 2021.
- MDA/GD/0032: Advertisement For Medical Device – Requirements
- Circular Letter of the Medica Device Authority No 1 Year 2020: Transition Period For Medical Device Advertisement.