• 2020-02-21 07:21:24

MDA has introduced new revisions to the Guidance Document on Import And/or Supply of Unregistered Medical Devices for The Purpose of Demonstration for Marketing or Education. All stakeholders are advised to take of these changes while making an application for the Notification of Medical Device for Demonstration purposes, to ensure a smooth process.

• 2020-02-21 07:20:48

The Ministry of Health (MoH) was recently notified by the MDA on a 'headphone' device that allegedly reduces and controls blood sugar levels, published through a local newspaper.

• 2020-02-15 08:22:55

In order to provide customers with more complete medical device regulatory services in the Asian region, Qualtech establishs service presence in Malaysia.

• 2020-02-21 06:59:18

MDA has introduced a revision to the Circular Letter No 1 of Year 2019: Post-Market Responsibilities for Manufacturer and Authorized Representative. This Ciruclar Letter essentially discusses all the duties and obligations which fall upon local manufacturers and local authorized representatives, after placing devices on the market.

• 2020-02-21 06:58:33

Recently, on 15th November 2019, the Malaysian Government passed the order to gazette Medical Device (Advertising) Regulations 2019 (‘Advertising Regulations’), based on the Medical Devices Act 2012.

• 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.