The Medical Device Authority (MDA) has announced the release of the Second Edition Guidance Document "Licensing for Establishments" (MDA/GD/0027). The newly MDA/GD/0027 covers the same scope as the First Edition:
a. The establishment licensing procedures
b. Licensing for multiple roles
c. Obligations of the establishment
d. Amendment to establishment license information
e. Renewal of establishment license.
The following are the main ideas of this Second Edition Guidance Document with the additional clause of the establishment's post-market responsibilities and the requirement to apply for a license for retailers and tendering agents.
Establishments shall:
a. Comply to the Medical Devices (Duties and Obligations of Establishments) Regulations 2019 that stipulates the post marketing requirements of medical devices; and
b. Be responsible for all medical devices that the establishment placed on the market.
c. Accomplish duties to continuously monitor and ensure the performance and safety of the medical devices in the market throughout the supply chain
Authorized Representative (AR) shall:
a. Carry out the post-market obligations even if the AR was terminated by a manufacturer or closed its business with no replacement. The AR needs to carry out the post-market activity for the medical devices placed in the market with the least accordance with the devices’ projected useful life as determined by the manufacturer.
b. The newly appointed AR that replaced the previous AR who closed its business shall be responsible for the post-market device placed in the market.
As stipulated in MDA/GD/0027, each activity requires a separate license accordingly. As an example, when the establishment carries out activities of a manufacturer and distributor, it shall require applying and obtaining both licenses for the manufacturer and distributor, accordingly. The renewal of the establishment license needs to apply at least 90 days before the expiry date. All new and renewal applications need to be submitted via the MeDC@St 2.0+ system.
The fees are outlines as below:
a. Application Fee: RM 250.00
b. Licensing Fee:
|
Type of License |
Fee (MYR) |
|
Manufacturer |
4,000.00 |
|
Authorized Representative (AR) |
4,000.00 |
|
Importer |
2,000.00 |
|
Distributor |
2,000.00 |
c. Renewal Fee:
|
Type of License |
Fee (MYR) |
|
Manufacturer |
2,000.00 |
|
Authorised Representative (AR) |
2,000.00 |
|
Importer |
1,000.00 |
|
Distributor |
1,000.00 |
For full details, you may refer to MDA/GD/0027.
References:
Second Edition Guidance Document “Licensing For Establishments” (MDA/GD/0027)