5th ASEAN Medical Device Committee (AMDC) Meeting in Indonesia

The Ministry of Health of the Republic of Indonesia will be hosting the 5th ASEAN Medical Device Committee (AMDC) Meeting, which will take place in JW-Marriott Hotel Surabaya, Indonesia from October 3rd to October 5th, 2017.

Medical device practitioners and regulators from Southeast Asia region will soon come together at the 5th ASEAN Medical Device Committee (AMDC) Meeting and its related meetings. The Ministry of Health of the Republic of Indonesia will be hosting the event, which will take place in the JW-Marriott Hotel Surabaya, Indonesia from October 3rd to October 5th, 2017.

The 1st AMDC meeting was held successfully in Malaysia and was attended by delegates from Singapore, Indonesia, Malaysia, Cambodia, Thailand, Myanmar, Philippines, Lao PDR, the ASEAN secretariat representative and the ASEAN Medical Industry representative. In this year’s meeting, medical device industry professionals are also encouraged to attend the stakeholder forum together with regulators. The Indonesian Association of Medical & Laboratory Appliance Enterprise (GAKESLAB) is also organizing industry training, in collaboration with the Asia Pacific Medical Technology Association (APACMed). This event will be held back-to-back with the main meeting.

The AMDC meeting provides essential updates on several topics relating to joint economic initiatives, the development of ASEAN standards and conformance, implementation of the ASEAN Medical Device Directive (AMDD), future cooperation, and training plans. We encourage all medical device professionals in Southeast Asia to attend the meeting, to ensure that you are kept up to date on the latest medical device information, regulations, and future planning for Southeast Asia.

2018-01-08T17:39:18+08:00 August 29th, 2017|News & Events|

India: Draft Essential Safety and Perfomance Principles for Medical Devices Out for Comment

The Central Drugs Standard Control Organisation (CDSCO), India’s medical device market regulator, is now seeking input from industry on draft essential safety and performance principles to be included in new regulations. The document includes seven high-level requirements applying to all medical devices and in vitro diagnostic (IVD) products registered for sale in India.

Following the issuance of new Medical Device Rules – 2017, which come into effect in January 2018, the Central Drugs Standard Control Organization (CDSCO), India’s medical device market regulator, is now seeking input from industry on draft essential safety and performance principles included in the new regulations.

Stakeholders have three weeks to comment on the CDSCO’s draft Essential Principles for Safety and Performance of Medical Devices, which make up part of India’s new Medical Devices Rules, 2017. The document includes seven high-level requirements applying to all medical devices and IVD products registered for sale in India.

Seven CDSCO Essential Principles
The CDSCO’s seven draft Essential Principles that would be applicable to all devices under the Medical Device Rules, 2017 include:

  • A device’s manufacture and design will ensure that it performs as intended without compromising patient or user safety.
  • Device design and manufacturing solutions should conform to state-of-the-art safety and risk-reduction principles.
  • A device’s design, production, and packaging should be suitable for its intended purpose under normal conditions of use.
  • The safety and performance of a device should not be compromised by the stresses that occur during normal use.
  • Transport and storage conditions should not adversely impact a device’s characteristics or performance.
  • A manufacturer should minimize all “known and foreseeable risks, and any undesirable effects” to optimize the benefits of using the device under normal conditions.
  • A device requires clinical evidence appropriate for its particular intended use and classification to show compliance with essential principles.

Along with the seven major principles for medical devices and IVDs listed above, the draft CDSCO document also addresses issues including chemical, physical, and biological properties; infection and contamination risk mitigation; combination products; and medical devices containing biological materials.

2018-01-08T17:40:11+08:00 August 29th, 2017|News & Events|

Meet us at the RAPS Regulatory Convergence, Booth 736

This year’s RAPS Regulatory Convergence will be held at National Harbor on the Washington DC Waterfront, US from the 9th to 12th September 2017. Visit us at booth 736 to meet with our consultants for a chat.

There are less than two weeks to go 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 will be located at Booth 736. Please feel free to meet our consultants for a chat or to answer your questions…they are always more than happy to help.

This year’s convergence will be at National Harbor on the Washington DC Waterfront, US from the 9th to the 12th September 2017. The exhibition will run on these dates and time:
September 10, 2017 at 6.00 pm -7.00 pm
September 11, 2017 at 10.00 am -4.00pm
September 12, 2017 at 10.00 am -4.00pm

This annual regulatory convergence gathers regulatory experts from all over the globe to share information, attend intensive workshops and topical sessions, learn about new technologies, and meet with regulators. Find out more about the event here.

See you at booth 736!

2018-01-08T17:56:37+08:00 August 29th, 2017|News & Events|

Malaysia Medical Device Authority: Full Implementation of Registration Requirements (1st January 2018)

The Malaysia Medical Device Authority issued a notice stating that, as of 1st of January 2018, the agency will fully enforce the medical device registration requirements as specified under Section 5 of the Medical Device Act 2012 (Act 737)

On the 25th of July 2017, the Malaysia Medical Device Authority (MDA) under the Ministry of Health issued a notice stating that, from 1st of January 2018, the agency will fully enforce the medical device registration requirements as specified under section 5 of the Medical Device Act 2012 (Act 737) before importing, exporting or placing medical devices in the Malaysian market. From that date onwards, all medical devices to be imported, exported or placed in the Malaysian market will need to meet the licensing and other requirements as set out in Section 5 of the Medical Device Act 2012 (Act 737). We advise any companies that have applied for the registration of medical devices under this Act, but have yet to submit all the information required, to complete the application on or before 31st of October 2017.

The announcement also stated that,as of 1st of January 2018, only the license establishment certificate and the medical device registration certificate are acceptable as supporting documents in the procurement process of medical devices in any health facility institution. The letter, “Acknowledgment receipt of application for medical device registration under Medical Device Act 2012 (Act 737)”, is no longer valid for use as a supporting document.
The notice is in Bahasa Malaysia and can be viewed here.

2018-01-08T17:41:38+08:00 August 29th, 2017|News & Events|