Asian Harmonization Working Party (AHWP) 2018 in Kuala Lumpur!

Do you want to learn more about the Medical Device Regulations in Asia? Have you ever thought of acquiring knowledge regarding artificial intelligence in healthcare? Or do you want to gain an understanding of the digital transformation of health and care?

The 23rd Asian Harmonization Working Party (AHWP) will be held at the Malaysia International Trade & Exhibition Centre (MITEC), Kuala Lumpur from 22nd October 2018 (Monday) to 25th October 2018 (Thursday). This 4-day event will help you gain an insight into the world of medical devices. Besides getting updates on the In Vitro Diagnostic (IVD) regulatory requirements and digital health regulations, you can also pick up information related to quality system certification and standards.

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2018-10-24T14:24:12+08:00 September 30th, 2018|News & Events|

The Philippines FDA: Drafted Administrative Order for the New Schedule of Fees and Charges

Background:

Enshrined in Sec. 12, Article XIII of the 1987 Philippine Constitution, it is the responsibility of the State to establish and maintain an effective food and drug regulatory system, that is responsive to the country’s current health needs and capable of providing innovative solutions to unfamiliar problems.

Consistent with this national policy, the Congress of the Philippines passed 3 landmark legislations namely: RA No: 9502 (Universally Accessible Cheaper & Quality Medicine Act of 2008), RA No: 9711 (FDA Act of 2009) and RA No: 10611 (Food Safety Act of 2013), for the promotion and protection of public health and welfare.

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2018-10-24T14:25:44+08:00 September 30th, 2018|News & Events|

Malaysia MDA: Measures to Reduce the Disruption of Medical Device Supplies Following Enforcement of the Regulations for Medical Device Registration

The Medical Device Authority (MDA) in Malaysia previously announced a moratorium on the full enforcement of the requirement to register medical devices with no extension granted after 30th June 2018. This means that as of the 1st July 2018, medical devices must be registered

Nevertheless, there are some applications that are pending registration and this may disrupt the supply of medical devices for patient diagnosis and treatment.

Thus, the MDA has implemented measures to reduce the disruption of medical device supplies in the market:

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2018-10-24T14:32:38+08:00 September 26th, 2018|News & Events|

Meet us at RAPS 2018!

radiation regulation

This year’s RAPS Regulatory Convergence will be held at the Vancouver Convention Centre in Vancouver, BC from the 1st to 4th October 2018. Visit us at booth 735 to meet with our consultants for a chat.

It is less than a month until the prestigious regulatory convergence by the Regulatory Affairs Professionals Society (RAPS) and, as one of the exhibitors, we are all geared up to meet you! Andaman Medical is pleased to be participating in this event again and we look forward to meeting you at Booth 735. Please feel free to meet our consultants for a chat or to answer your questions…they are always more than happy to help!

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2018-10-24T14:32:59+08:00 September 2nd, 2018|News & Events|

Malaysia: Extended Transitional Period for Medical Device Labeling

labeling requirements

Back in 2016, the Medical Device Authority in Malaysia decided to implement a 2-year transitional period for medical device manufacturers to comply with labeling requirements. With the release of a recent circular, the transitional period has been extended by three years.

The Malaysian Medical Device Authority (MDA) has released a circular, dated 5th August 2018, announcing an extension to the transition period for medical device labeling requirements. The circular supersedes the previous circular, released 2 years ago.

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2018-10-24T14:34:03+08:00 September 2nd, 2018|News & Events|

Risk Classification of Medical Devices in Vietnam

risk classification

In Vietnam, medical devices must be classified by a locally established, qualified organization in accordance with the risk classifications provided in Circular No. 39/2016/TT-BYT dated October 28, 2016.

In Vietnam, all medical devices must be classified according to their level of risk when applying for a declaration of applicable standards or registration of free sale (Article 4, Decree No.36/2016/ND-CP).

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2018-10-24T14:34:56+08:00 September 2nd, 2018|News & Events|