The Medical Device Authority of Malaysia (MDA) made an announcement on December 13, 2022, pertaining the renewal of an establishment license. The establishments that are being referred to are the local manufacturers, authorized representatives (AR), distributors, and importers. An establishment that needs to renew the license with MDA shall apply 90 days before the license expires.
With the changes to this license terms condition, the licensee must submit the renewal before 90 days of the expiration date. MDA stated that applications submitted after the expiration date will not be accepted and require the submission of a new license application. The fee paid for the late renewal will not be refunded, i.e. those made after the allotted 90-day window.
It is reminded as provided in section 19(1) and 19(2) of Act 737, that establishments are required to comply with the license condition as below:
- (1) A licensee shall comply with the conditions imposed by the Authority on the establishment licence.
- (2) Any licensee who contravenes subsection (1) commits an offence and shall, on conviction, be liable to a fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding one year or to both.
The establishment is responsible for carrying out post-market duties for medical devices that are exported, imported or put on the market (even in the situations described below), until the end of the projected useful life of the device as below:
a. An AR who, after selling the medical device, is fired by the manufacturer or shuts down his/her company.
b. A local manufacturer that has ended its business after placing a medical device on the market.
The Establishment License will be suspended or cancelled if it is determined that the Licensee violated the act, rules, or conditions of the license as stated in Section 22, Act 737.
Licensing for Establishment, Amendment to License Terms, Act 737, Appendix 1 of Amendment of License Terms