CMEF Indonesia 2019: Medical Equipment And Manufacturing Exhibition

Expand your medical device distributorship and local manufacturing business at CMEF Indonesia 2019

CMEF Indonesia 2019, A Medical Equipment And Manufacturing Exhibition, brings together international medical equipment brands to connect with locally licensed medical equipment distributors, resellers, manufacturers, regulators, and government agencies. The event gathers the world medical devices community together in Asia, so you can expect to meet distributors, resellers, manufacturers, hospital management from Indonesia together with over 200 international medical brands, products, and solutions

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2019-02-04T10:42:28+00:00 February 4th, 2019|Event, News & Events|

Thailand Government Project: Medical Tourism Destination

medical tourism

Thailand is one of the most popular medical tourism destinations in the world. Healthcare professionals and facilities in Thailand are known for providing excellent service in various disciplines such as plastic and reconstructive surgery, orthopedic surgery, cardiac surgery, and dental care.

The Thai government wants to make Thailand a leading destination for pharmaceuticals and medical devices and a world-class provider of medical care, including medical tourism.

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2019-02-04T06:15:24+00:00 February 4th, 2019|Insight, News & Events|

Singapore: Preparation of Medical Device Registration Dossiers

In November 2018, the Health Services Authority (HSA) Singapore released an update to the Medical Device Registration Dossier guidance documents GN17 & GN18 (Guidance for Preparation of Submission for General Medical Devices and In Vitro Diagnostic Medical Devices using the ASEAN CSDT) following industry feedback that the previous versions were too complex and lacked clarity.

The Health Services Authority (HSA) Singapore has revised current Medical Device Registration Dossier guidance documents following industry feedback that they were too technical, complicated and lacked clarity. After much deliberation, the HSA released revamped versions of the documents, that are simple, salient, brief and clearly expressed.

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2019-02-04T05:46:40+00:00 February 4th, 2019|Insight, News & Events|

ASEAN Medical Device Directive (AMDD) – Progress and Updates by AMDC

ASEAN Medical Device Directive (AMDD) was signed by ten member states which include Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam.

The ASEAN Medical Device Committee (AMDC) was established with the overall responsibility of coordinating, reviewing and monitoring the implementation of the institutional agreement and shall comprise representatives from the Regulatory Authority of each member state. AMDC scheduled regular meetings twice a year and the recent meeting was held in Bangkok, Thailand in December 2018 while the next meeting will be in the Philippines.  

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2019-01-02T15:54:43+00:00 January 2nd, 2019|Insight, News & Events|

Malaysia : License Transfer in Malaysia

License transfer, usually known as change of ownership, is a common procedure in Malaysia, where the registration certificate of the medical device will be transferred from the existing Authorized Representative (AR) to the new AR

The new AR must hold valid Medical Device Authority (MDA) establishment license, in order to place the medical device in Malaysian market. To conduct the change of ownership of the medical device, the manufacturer must ensure that the existing AR has completed the registration and holds the registration certificate of the medical device (with no pending application in the system).

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2019-01-02T14:58:13+00:00 January 2nd, 2019|Medical Regulation Updates, News & Events|

Indonesia: Brief Report of Medical Device Registration and Household – Health Device Registration in 2018

In relation to the end of year, Ministry Health of Indonesia closes the e-registration system started from 17 November 2018 and will be opened at 14 January 2019.

During 2018, the highest number of medical device licenses issued is on March, numbered 1299 licenses. Whereas the highest number of household-health device licences issuance is numbered 196 licences on January. According to statistical data from Ministry of Health, December is the month with the least number of licenses issued throughout 2018. (more…)

2019-01-02T14:58:55+00:00 January 2nd, 2019|Medical Regulation Updates, News & Events, Uncategorized|

Indonesia: Implementation of a Digital Signature System for Medical Device Registration

On the 1st January 2019, the Ministry of Health in Indonesia will launch a new digital signature system for the approval of medical device, in vitro diagnostic and household-health device registration licences.

In Indonesia, the approval of the medical device, in vitro diagnostic and household-health device registration licences (based on regulation no. 62/2017) will be issued by the Ministry of Health by electronic form. Previously, licenses were issued in hardcopy format only with the original signature of the Directorate General of Evaluation of Medical Device Registration and Ministry of Health’s stamp. There are several advantages of this paperless system as it saves time, is more secure, is better for the environment as it reduces printing requirements, and can prevent any unnecessary duplication by individuals. 

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2019-01-02T14:08:09+00:00 December 4th, 2018|Uncategorized|

The Philippines: Guidelines on Radiation Safety Standards

radiation x-ray

The Philippines FDA has published a draft Administrative Order to provide guidance on fulfilling the requirements of the General Safety Requirements (GSR) Part 3, published by the International Atomic Energy Agency (IAEA), with respect to the medical use of ionizing radiation.

The medical use of ionizing radiation is among the longest established applications of ionizing radiation. In the Philippines, there are about 3,000 x-ray facilities offering diagnostic and interventional procedures, which brings considerable public health benefits. However, ionizing radiation can cause harm and a systematic approach should be applied to ensure that there is a balance between deriving the benefits from medical uses of x-rays and minimizing the risk of radiation effects to patients, workers, and members of the public. 

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2018-12-04T09:35:48+00:00 December 4th, 2018|Uncategorized|

Malaysia: New Medical Device Labelling Requirements (Third-Edition, November 2018)

guidance document

On 12th November 2018, the Medical Device Authority (MDA) in Malaysia released the third edition of the labelling requirements guidance document, which supersedes the guidance document (second edition) released in January 2018. 

The table below highlights some of the major differences between the second edition of the guidance document, which was released in January 2018, and the third edition of the guidance document, which was released in November 2018. 

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2018-12-04T09:32:06+00:00 December 4th, 2018|Uncategorized|