• 2020-02-21 06:57:58

The Medical Device (Duties and Obligations of Establishments) Regulations 2019 (‘Establishments Regulations’) specifies in detail the responsibilities of establishments involved in the importation, distribution and post-market surveillance of medical devices in Malaysia.

• 2020-05-06 07:52:16

All locally marketed medical devices must have their post-market activities continuously monitored until their projected useful life expires. If the current AR or manufacturer go out-of-business, it is their responsibility to find replacement to take care of this or continue monitoring.

• 2020-05-06 05:10:35

In a recently issued revised guideline on How to Apply for Medical Device Registration Under Medical Device Act 2012 (Act 737), MDA specified that it can drop an ongoing application from MeDC@St system if it exceeds a 90 days stop-clock-time and any new applications which do not conform to requirements specified will be rejected, non-refundable.

• 2020-05-06 05:08:37

MDA has reminded all stakeholders that it is unlawful to market unregistered medical devices with no clinical evidence in Malaysia. In a latest announcement, MDA advises the general public not to believe and be affected by advertisements which contain claims made on this type of devices.

• 2020-05-06 03:45:58

MDA has issued a new guidance document on notification of medical device for special access. A draft for this guidance document was issued earlier this year and based on public comments and suggestion, some changes have been made in the official release document.

• 2020-05-06 03:06:32

MDA has launched a new web-portal, replacing the old one and a new Feedback Management System (FEMES). These new web-portal and FEMES system have been introduced to provide better information delivery and take note of customer feedbacks more effectively.

• 2020-05-06 02:40:59

MDA is organizing the MyMEDEX exhibition for a second time and International Medical Device Conference 2019 from 15th to 17th October 2019, at the Malaysia International Trade & Exhibition Centre (MITEC).

• 2020-05-05 07:31:28

Registration of both local and foreign-manufactured medical devices in Malaysia is generally a two-part process. They are mainly regulated by the Medical Device Authority (MDA) of Malaysia, a local regulation and authorization body.

• 2020-05-05 06:40:46

MDA has issued a new guidance document on how to bring in special-access devices for specific purposes into Malaysia. MDA defines special access medical device as medical device for the use of medical practitioners in emergency situations or in the event that conventional medical treatment has failed, is unavailable or unsuitable.

• 2020-05-05 06:26:29

MDA has issued a draft guidance document for getting an exemption for export-only medical devices from registration requirement. This draft is open for public comment and the official document is expected to be released soon.