• 2024-03-01 09:11:58

The NMPA decided to establish a technology-centralized unit for the standardization of medical device packaging.

• 2022-11-29 02:42:41

The Medical Device Authority (MDA) updates the guideline for Licensing for Establishments. The establishment must comply to Medical Devices (Duties and Obligations of Establishments) Regulations 2019 that stipulates the post marketing requirements of medical devices. The Medical Device Authority (MDA) created this guidance document to assist the healthcare sector and the industry in their efforts to comply to the Medical Device Act's (Act 737) laws and requirements.

• 2022-08-30 03:32:59

Starting July 1, 2022, MDA fully implemented the Medical Device (Responsibility & Establishment) Regulations.

• 2021-09-29 02:05:59

Starting July 1, 2022, MDA will start to fully enforce the Medical Device (Duties and Obligations) Regulations 2019 or better known as 2019 Regulations. The regulations focus on various medical device-related establishments’ responsibilities on post-market activities.

• 2020-12-23 07:07:34

The Vietnam Ministry of Health has issued Circular No. 14/2020/TT-BYT dated 10 July 2020 (“Circular No. 14“), which regulates various aspects of the bidding process of medical devices for public health establishments. This circular took effect on 1 September 2020.

• 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.

• 2020-07-31 10:40:17

ThaiFDA is highly concerned with the health and the well-being of the people abrupt from the situation of PM.2.5 in Thailand. Respectively, the “Letter of Notification: Registration of Importer Establishment License and Registration of Medical Mask for Special Circumstance” was announced.

• 2020-05-06 06:04:19

Thai FDA is highly concerned with the health and the well-being of the people abrupt from the situation of PM.2.5 in Thailand. Respectively, the “Letter of Notification: Registration of Importer Establishment License and Registration of Medical Mask for Special Circumstance” was announced.

• 2020-02-12 15:06:56

MDA has issued a new announcement regarding registration application of medical devices and licensed establishment under Medical Devices Act 2012 (Act 737) which are still pending, following the end of transition period.

• 2020-02-14 04:09:43

MDA has released a new regulatory update, pertaining to Licensing Conditions for All Licensed Establishments under the Medical Device Authority in Malaysia. There have been some critical inclusions to the licensing requirements for all licensed establishments in MDA.