• 2020-02-15 06:17:38

On October 9, 2017, Medical Device Authority (MDA) Malaysia released a Second Edition of the Guidance Document on Change Notification for Registered Medical Device. This GD serves a great purpose in informing the stakeholders on the categories of changes, notification process and relevant requirements for applying for a change notification in Malaysia.

• 2020-02-15 06:16:53

n order to ensure that the 3D printing production of medical equipment is scientific, safe and effective, and to uphold consumer protection, the Taiwanese Food and Drug Administration (TFDA) commissioned the national Cheng Kung University to develop a draft of "the product management guideline for 3D printing medical device,” which is applicable to medical devices which use 3D printing technology in their manufacturing process.

• 2020-02-14 15:26:51

• 2020-02-14 15:25:25

On 13 November 2017, Medical Device Authority (MDA) released the Medical Device (Declaration) Order 2017, which comes into operation on 1st of January, 2018. In this order, the MDA declares “Non-Corrective Contact Lenses”, also commercially known as “Cosmetic Contact Lenses”, as legitimate medical device.

• 2020-02-15 06:31:28

HSA has finalized the Guidelines for Telehealth Products. Telehealth products refer to "instruments, apparatus, machines or software involved in the provision of healthcare services over physically separate environments via information communication technologies."

• 2020-02-15 06:30:30

HSA drafted Guidance 34 for IVD Analyzers, to address the concerns of product owners and registrants with IVD analyzers and their associated accessories. GN-34 is “intended to act as a ‘one-stop’ document for IVD analyzers”.

• 2020-02-15 06:29:49

  Recently, there have been a string of announcements released by the Malaysian Medical Device Authority to provide clear guidelines on certain matters. Following this, the MDA has released a new Guidance Document on Conformity Assessment for Medical Device that are yet to be registered.

• 2020-02-15 06:29:08

Malaysia’s healthcare system consists of two tiers: a state-owned universal healthcare system for national citizens runs alongside a private sector that serves international patients.  Due to projected demographic shifts – chiefly Malaysia’s ageing population, increasing life expectancy and the growth of non-communicable diseases – demand for medical device is expected to grow.

• 2020-02-15 06:28:26

 Indonesia Hospital Association will hold the 30th Indonesian Hospital Expo on October 18-21st 2017 in JCC Senayan, Jakarta. This is the biggest medical device exhibition in Indonesia which is participated in by both foreign and local companies to exhibit their products. The number of exhibitors and visitors are increasing every year,

• 2020-02-15 06:27:24

 Starting in 2017, all medical devices imported into Vietnam will be required to register for Marketing Authorization (MA) licenses. The Ministry of Health began receiving registration dossiers on January 1, 2017, for medical devices categorized as Class A, and began receiving dossiers on July 1, 2017, for medical devices in Classes B, C, and D.