On 20 May 2020, the Medical Device Authority (MDA) in Malaysia, released its first circular letter of the year, stating that there will be a transitional period for the enactment of the Medical Device (Advertising) Regulation 2019. This regulation was due to come into full effect on 1st July 2020. However, due to some implementation issues that require more time to be resolved, the implementation date has been extended to 31st December 2021.
As a reminder: the Malaysian Federal Government released a regulation related to the advertisement of medical devices in Malaysia back in November 2019. According to the Medical Device (Advertising) Regulation 2019, no person shall advertise any registered medical device without the approval from the Authority. Any person who commits an offence, shall, upon conviction, be liable to a fine not exceeding two hundred thousand ringgit or to imprisonment for a term not exceeding two years, or to both.
The Medical Device (Advertising) Regulation 2019 also states that applications for approval for an advertisement shall be submitted in writing to the MDA along with a copy of the proposed advertisement, the processing fee of one thousand ringgit (approx. 235 US Dollars) and a letter of appointment from the establishment whose medical device is being advertised if applicable. Each advertisement must include the registration number assigned by the MDA to the said medical device.
However, the decision of the MDA to introduce a transitional period of 18 months (commencing from 1st July 2020 until 31st December 2021) for the implementation of Medical Device (Advertising) Regulation 2019, will now allow the MDA together with the medical device industry to specify details on its implementation.
This circular letter was issued under Medical Device Act 737 and is effective from the date of issue. Click here to read the full circular letter on the transitional period for medical device advertising in Malaysia.
If you have any queries regarding the transitional period for medical device advertising or our services for medical device registration and representation in Malaysia, please contact us at email@example.com.