Section 5 (1) of Medical Device Act 2012 (Act 737) requires a medical device to be certified under the Act before it can be ferried, delivered, or located in the market. For that goal, an application for a medical device registration must be made in accordance with the specification under Act 737 and comparable settled by the Authority in Medical Device Regulations (MDR) 2012.
With Act 737 commencement date on 1 July 2013, all medical device that are available in the market must be registered under the Act and the application for registration can be made to the Authority through the website named “Medical Device Centralized Online Application System (MeDC@St)”. Those registrations with the Authorities will have a validity period of 5 years and when the expiry date for the certification of registration of medical devices draws near, the holder must apply for a re-registration online before any action can be taken in the market.
The purpose of these new guidelines is to administer information and produce explanation to various organizations on the procedures to submit re-registration of medical devices dependent on Act 737 and MDR 2012.
Re-registration Stages of Registered Medical Device
The procedures to do re-registration of medical devices involves 2 following processes stated below:
1. Application for Conformity Assessment Body (CAB) to manage conformity assessment
Apart from medical devices classified under Class A, conformity assessment will be managed by CAB. Before re-registering of medical devices on MeDC@St, the purchaser will implement for conformity assessment as essentials certified in MDR 2012 Third Schedule are stated as conformity assessment of:
Quality management system (QMS);
Post market surveillance system;
Technical documentation; and
Declaration of conformity (DoC)
CAB will analyze any modifications made on the notification documents that are approved by MDA.
2. Application for re-registration on MeDC@St
Re-registration applications can also be made through MeDC@St application system where the procedure to re-register will be displayed prior a year before the expiry date.
If the purchaser has done any change notification, the procedure to do re-registration will also appear on the completed change notification application. This process only applies if the application is completed.
The changes cannot be made on the application, unless these changes are permitted under the application for Change Notification as defined in the document MDA/GD/0020 Change Notification for Registered Medical Device.
Source:
Contact us at info@arqon.com for more information.