Conformity Assessment Body (Cab) Requirements for Registration

Procedures to access clients’ medical device conformity against the following elements (where applicable):
i. quality management system (QMS);
ii. post-market surveillance system;
iii. technical documentation giving particular attention on the following elements where applicable:

• design dossier reviews;
• assessment of clinical and bio-compatibility data;
• medical device containing animal tissues;
• sterile medical device;
• other specialised technologies; and
• clinical pathology aspects of in vitro diagnostic, etc

iv. declaration of conformity.

Requirements for Labelling of Medical Devices

Clinical Research Study  

As specified in the Fifth Schedule of the Medical Device Regulation 2012, the application and registration fee are imposed as follows:

The manufacturer may use the DoC template in Annex A to draw up a declaration of conformity to comply with the DoC format as in Part II of Appendix 3 of MDR 2012. With the DoC, the manufacturer attests that its medical device complies fully with all essential principles for safety and performance and other requirements specified in the Act 737 and its regulations. The manufacturer shall also provide sufficient documents or evidence to support its DoC.

Certificate of Free Sale / Manufacturing Certificate

Any incident, which meets the three basic reporting criteria listed below, is considered as reportable. The criteria are that: -
a) an incident has occurred;
b) the medical device is associated with the incident; and
c) the incident led to one of the following outcomes;
           i) serious deterioration in state of health, user or other person. A serious deterioration in state of health can include: -
                  − life-threatening illness or injury;
                  − permanent impairment of a body function or permanent damage to a body structure; or
                  − a condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure;
           ii) death of a patient, user or other person;
           iii) a serious threat to public health; or
           iv) no death or serious injury occurred but the incident might lead to death or serious injury of a patient, user or other person if the incident recurs.

As soon as any personnel of the medical device manufacturers or its authorised representative, including sales personnel, are made aware of the incident, the timeline for reporting starts as follows;
a) within 30 days after the establishme

Determining the need of a FCA is the responsibility of the manufacturer.
a) The manufacturer shall perform a risk assessment in accordance with ISO 14971. The Authority may instruct additional measures by the manufacturer or authorised representative to safeguard public health in case the Authority finds that the risk assessment performed by the manufacturer is deficient.
b) FCA could be triggered from the establishment’s post market surveillance information (product complaint, adverse incidents, etc.) that indicate an unacceptable increase in risk.

There are 2 types of Recalls
1. Requirements for Voluntary Recall

2. Requirements for Mandatory Recall

Medical device intended for healthcare professional use only, shall not be advertised to the general public.

No establishment shall import, export, or place in the market any registered medical device unless it holds an establishment license granted under the Act.