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.

(more…)

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.

(more…)

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.

(more…)

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