• 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.

• 2020-02-15 06:26:28

On October 8, the General Office of the CPC Central Committee and the General Office of the State Council issued "the Reformed Examination and Approval System of CFDA to Promote Drug and Medical Device Development and Innovation", and required all localities and departments to implement.

• 2020-02-15 06:42:49

 The 5th ASEAN Medical Device Committee (AMDC) Meeting will be held from October 3 to 5, 2017 in Surabaya, Indonesia, along with its related meetings.

• 2020-02-15 06:41:57

The Medical Device Branch of the Health Products Regulation Group of Health Sciences Authority (HSA) launched two schemes which came into effect starting August 1st 2017.

• 2020-02-15 06:40:47

he Philippine Food and Drug Administration (FDA) held its First Regulatory and Advocacy Fair last August 17 and 18, as part of the celebration of its 54th anniversary.

• 2020-02-15 06:39:56

China Food and Drug Administration (CFDA) is planning to require foreign registrants to provide its company information in Chinese, such as company name and addresses.