• 2020-02-21 07:07:52

The PFDA released the draft fees in preparation to the authority’s adaptation to the ASEAN Medical Device Directive (AMDD) risk-based classification.

• 2020-02-21 07:07:01

For both GN-21 and GN-34, HSA added guidance regarding notification of software changes in In Vitro Devices (IVD) .

• 2020-02-21 07:06:15

“Essential Regulatory Requirements for Medical Device Approval” Seminar by The Medical Products Consortium of Thailand: MPCT on 27-28 February 2020 is being hosted for the first time in Thailand aiming to promote research develop medical device innovation through the certification assessment process of The Food and Drug Administration Medicine accordingly to international guidelines.

• 2020-02-21 07:05:31

The Ministry of Public Health of Thailand announced a draft drug for hyaluronic acid for non-injection for skin correction

• 2020-02-21 07:04:40

Thai FDA clarifies 3 types of classification of non-in vitro medical device, Licensed medical device, Notified medical device, and General medical device regarding risk assessment. And for In-vitro medical device, the product is classified from class 1 to class 4.

• 2020-02-21 06:46:06

IMPLANTED SILICONE BREAST PROTHESIS 2019

• 2020-02-21 07:00:53

CDSCO has issued a notice recently regarding intended uses of implantable medical devices, as stipulated in the Fifth Schedule (Clause 3.5) of Medical Devices Rules, 2017.

• 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.