JANUARY 2024 REGULATORY OVERVIEW
MALAYSIA
First Edition Guidance Document on Importation of Medical Device for Personal Use
30th January 2024
The guidance document - MDA/GD/0066 - was published by the Medical Device Authority (MDA) to guide the import of medical devices for the purpose of personal use.
A medical device for “personal use” is defined in the guidance document as “a medical device which is brought into Malaysia for the use of a particular individual only and not to be placed in the market”. The person who imports medical device for personal use is exempted from the requirement of an establishment license under Section 15 of Act 737.
The following are requirements set forth in the guidance document for import or purchase (including via online platform) of medical devices for personal use:
a) only for home-use medical devices;
b) the medical device is for own use or the use of immediate family;
c) all labels and labelling information that comes with the medical device shall be retained;
d) quantity for medical device shall be appropriate according to the type of the medical device;
e) no same or similar medical device(s) is/are registered in Malaysia; and
f) to obtain a formal prescription or letter of recommendation on the medical device(s) from a registered healthcare professional upon request from the Authority.
The original MDA announcement can be accessed here, while the guidance document MDA/GD/0066 can be downloaded here.
For further enquiries, please contact us at Mtresponder@medtechconsulting.com.my or utilise our contact form.
First Edition Guidance Document on Medical Device Post Market Information Exchange for ASEAN Member States
30th January 2024
Following the recent Twelfth Meeting of the ASEAN Medical Device Committee (AMDC) held at Brunei Darussalam in September 2023, the Medical Device Authority (MDA) has decided to adopt the Guideline on Medical Device Post Market Information Exchange for ASEAN Member States that was ratified during the meeting.
The first edition of this guidance document, namely the Guidance Document on Medical Device Post Market Information Exchange for ASEAN Member States (MDA/GD/067), was published on 30th January 2024 and serves to provide guidance on the exchange of post market information of medical devices among ASEAN Member States (AMS). This post market information may include events leading or highly likely to lead to unanticipated public health threat, as well as observations from national trend analysis.
The original MDA announcement can be accessed here, while the guidance document MDA/GD/0067 can be downloaded here. For further enquiries, please contact us at Mtresponder@medtechconsulting.com.my or utilise our contact form.
SINGAPORE
Regulatory Fee Revision for Medical Devices and other Health Products
8th January 2024
The Health Sciences Authority (HSA) has announced an increase in fees related to the cost of registration, licensing, notification and permit issuance for medical devices and for other health products. This fee revision will take effect starting on 1st July 2024, and is necessary to recover part of the costs for the services rendered to businesses.
The Health Sciences Authority (HSA), Singapore has officially announced a forthcoming adjustment in fees pertaining to the registration, licensing, notification, and permit issuance for medical devices and other health products. This revised fee structure is slated to come into effect from 1st July 2024.
The rationale behind this fee revision is to recuperate a portion of the expenses associated with the services provided to businesses in the respective sectors. The HSA emphasises the necessity of this measure to ensure sustainable support for the delivery of quality services in the realm of healthcare product regulation.
The original HSA announcement can be accessed here, while the list of revised fees for Medical Devices can be downloaded here. For further enquiries, please contact us at Mtresponder@medtechconsulting.com.my or utilise our contact form.