• 2020-02-14 04:24:02

Thai FDA published an eye-related product classification checklist guide to help determine whether each product fall under the category of not medical device, medical device, drug, or cosmetic.

• 2020-02-14 04:23:23

TFDA Department of Medical Device and Cosmetics is set to move to a new office starting on April 30, 2018. The new office will be located at the Alley 12, 2nd Section of Yan Jiu Yuan Road, Nangang District, Taipei City.

• 2020-02-14 04:22:39

The ASEAN Medical Device Directive (AMDD) was signed by the ten (10) Member States in 2015, with the main objective of harmonizing the medical device regulations and common technical documents which may help medical manufacturers easily penetrate the ASEAN Medical Device Market.

• 2020-02-14 07:53:58

edtec Japan, Asia’s largest tradeshow dedicated to the design and manufacturing of medical devices will take place from 18 to 20 in April 2018 at Tokyo Big Sight. Qualtech, as a professional medical device regulatory consulting firm in Asia, will participate the event this year to provide regulatory solution for all medical devices to meet the requirement in Asia countries

• 2020-02-14 07:45:46

The Medical Device Authority (MDA) has issued a new Circular Letter on March 5th 2018 bearing new requirements for the licensing and medical device registration for Original Equipment Manufacturer (OEM) in Malaysia. This circular letter identifies who construes as an OEM and the reason why OEMs are not regulated under the Medical Devices Act 2012 (Act 737) till far.

• 2020-02-14 07:43:27

Following a list new regulations and requirements released in March 2018, MDA has issued a new guidance document which specifies requirement on notification for importation and/or supply of medical devices intended solely for the purpose of demonstration for marketing or for the purpose of education.

• 2020-02-14 07:43:27

Based on a recently issued circular letter, No. 3 Year 2017 (Rev.1), MDA has reiterated the implementation and enforcement date for the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combinations Products, which will be strictly enforced in Malaysia starting July 1st, 2019.

• 2020-02-14 07:42:08

On 30th of November 2017, following recommendation from the Advisory Board, Thai FDA had announced four new checkpoints which regulate importation and exportation of medical devices. The new checkpoints are located in four different provinces as follows:

• 2020-02-14 07:41:28

The Thai Medical Device Control Division has amended the application form for medical device advertising following the Thai FDA announcement on 19 January 2018. It is appropriate to report complete and clear information to monitor the impact of disclosure.

• 2020-02-14 07:40:37

In light of the new Medical Device Rules 2017, CDSCO/CLA/SLA shall have updated information of laboratories involved in testing of medical device & in vitro diagnostics with respect to their laboratory reports and decision on performance evaluation of products made by stakeholder/regulator.