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+08:00 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+08:00 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+08:00 December 4th, 2018|Uncategorized|