Vietnam: Medical Software Class Exempt from Registration & Import Licensing Under the New Decree

medical software

As technology continues to evolve in healthcare, computer software has become an important part of many products, integrated widely into digital platforms that serve both medical and non-medical purposes. In Vietnam, the implementation of decree 169/2018/ND-CP in January 2019 has seen changes in the regulation of software for medical purposes with such software now exempt from registration and import licensing.

In Vietnam, according to the previous version the medical device regulations (Circular 30/2015/TT-BYT [list of products requiring an “import license”] and Decree 36/2016/ND-CP), medical software was required to undergo product registration if the manufacturer wished to import it into the Vietnam market.

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2019-04-05T13:57:55+08:00 April 3rd, 2019|Insight, Medical Regulation Updates, News & Events|

Singapore: Measures To Strengthen Health IT Systems

On March 6th, Health Minister Gan Kim Yong announced that several measures are being taken to strengthen health IT systems in Singapore. These measures follow last year’s cyber-attack on SingHealth that resulted in the theft of 1.5 million patients’ particulars.

Integrated Health Information Systems (IHiS), the IT vendor for Singapore’s healthcare sector, is working to roll out a feature that lets patients view the access logs of their own National Electronic Health Record (NEHR) data.

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2019-04-05T13:57:35+08:00 April 3rd, 2019|Medical Regulation Updates, News & Events|

The Philippines: Dangerous Drug Certification And Exemption

controlled chemical

The Philippines Dangerous Drugs Board has issued Board Regulation No. 1, S. 2014 requiring certification for non-controlled chemicals and a certificate of exemption/board resolution for the exemption of products/chemical mixtures containing controlled chemicals.

The Philippines Dangerous Drugs Board has issued Board Regulation No. 1, S. 2014 requiring certification for non-controlled chemicals and a certificate of exemption/board resolution for the exemption of products/chemical mixtures containing controlled chemicals. All applications must be made PRIOR to importation and arrival of the shipment.

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2019-04-04T05:42:05+08:00 April 3rd, 2019|Medical Regulation Updates, News & Events|

Meet us at CMEF Indonesia 2019!

CMEF Indonesia 2019

It is less than a month until CMEF Indonesia 2019, a medical equipment and manufacturing exhibition that brings together international medical equipment brands to connect with locally licensed medical equipment distributors, resellers, manufacturers, regulators, and government agencies. 

We are all geared up to meet you! Andaman Medical is pleased to be a Knowledge Partner for CMEF Indonesia 2019 and we look forward to meeting you at our booth in the Consultancy Lounge. 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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2019-03-05T10:16:56+08:00 March 4th, 2019|Event, News & Events|

Malaysia: MeDC@St 2.0

The Medical Device Authority (MDA) in Malaysia launched a new database, MeDC@St 2.0, on the 2nd January 2019 to assist authorized representatives, importers, or distributors in registering their medical devices. As of the 21st December 2018, all draft applications in MeDC@St 1.0  are not able to be submitted using the previous system. 

All applications that were submitted in MeDC@St 1.0 before 21st December 2018, and were either in “Processing” or “Pending Payment” will continue to undergo evaluation by the Medical Device Authority (MDA) officer until their approval; however, all new applications for medical device registration must be submitted using MeDC@St 2.0.

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2019-03-04T06:29:36+08:00 March 4th, 2019|Event, News & Events|

Indonesia: Special Access Scheme Registration

In relation to the 2009 Health Regulation no. 36, which was implemented to drive transparent and accountable public service, the Ministry of Health in Indonesia has published guidance on the procedures to import medical devices through the Special Access Scheme (SAS).

In relation to the 2009 Health Regulation no. 36, which was implemented to drive transparent and accountable public service, the Ministry of Health in Indonesia has published guidance on the procedures to import medical devices through the Special Access Scheme (SAS).

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2019-03-04T05:16:46+08:00 March 4th, 2019|Event, News & Events|

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+08:00 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+08:00 February 4th, 2019|Insight, News & Events|