Vietnam: In Vitro Diagnostic Reagent Registration And Importation

Registration numbers of medical devices that are In Vitro Diagnostic Reagents and granted the Certificate of Registration in accordance with the 2005 Law on Pharmacy and its instructional documents, will be effective until the expiration date on their Certificate of Registration.

The registration numbers of In Vitro Diagnostic Reagents with an expiry date after January 01, 2019 and before December 31, 2019 will be effective until the end of December 31, 2019.

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2019-06-04T20:34:37+08:00 June 4th, 2019|Insight, Medical Regulation Updates, News & Events|

Singapore: Update For Change Notification Guidance For Registered Medical Devices

On March 28th, 2019, the Health Science Authority (HSA) provided updates corresponding to the GN 21: Change Notification of Registered Medical Devices.

The updates come following industry feedback to the range of terminology used across the various guidance documents and the lack of clarity in documentary requirements for different change notification cases.

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2019-06-04T20:28:33+08:00 June 4th, 2019|Insight, Medical Regulation Updates, News & Events|

Indonesia: Temporary Shutdown Of The Medical Device Online System By The Ministry Of Health

The Ministry of Health of Indonesia has advised of a maintenance period of the medical device registration online system running from 27 May 2019 until 10 June 2019.

During this period, the estimated timeline for applications already submitted will be stopped and added once the system has reopened again. The system will be closed for applications with status of new submission/renewal/amendment, government fee payment, and additional enquiry. Further to the announcement, the Ministry of Health will also close the system for certification services from 28 May 2019 until 10 June 2019. In addition to the medical device registration online system, the Ministry of Health will also close the system for the medical device certification for GDPMD applications, medical device distribution license applications (IPAK), and production certificate applications from 30 May 2019 until 9 June 2019. For this system, the terms and conditions will remain the same as the medical device registration online system.

2019-06-05T05:20:48+08:00 June 4th, 2019|Insight, Medical Regulation Updates, News & Events|

The Philippines: Amendment To Administrative Order No. 2018-002.

On January 26, 2018, the Food and Drug Administration of the Philippines (FDA) issued the Administrative Order No. 2018-002: Guidelines Governing the Issuance of an Authorization for a Medical Device based on the Association of Southeast Asian Nations (ASEAN) Harmonized Technical Requirements. Although the new policy is already in place, the exact implementation date is unknown.

In connection with this, the Philippine food and Drug Administration (FDA) has requested that all concerned parties submit their comments on the draft Amendment to Administrative Order No. 2018-002:  Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements. All comments should be sent to cdrrhr.lrd@fda.gov.ph on or before 31 July 2019.

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2019-06-05T05:30:02+08:00 June 4th, 2019|Insight, Medical Regulation Updates, News & Events|

Thailand: Approval Of Public Sale Of Home HIV Test Kits Via Pharmacies

The Thai FDA and Department of Disease Control and the Thai Red Cross AIDS Research Centre have approved the public sale of home HIV test kits via pharmacies.

Thailand has one of the highest HIV prevalences in Asia and the Pacific, accounting for 9% of the region’s total population of people living with HIV; however, it was the first country to effectively eliminate mother to child transmissions, with a transmission rate of less than 2%. (more…)

2019-05-02T10:54:03+08:00 May 2nd, 2019|Insight, News & Events|

The Philippines: 2019 FDA Academy Training and Seminar Schedule

FDA Academy

The Food and Drug Administration in the Philippines established the FDA Academy to provide access to relevant and effective training as part of its continuous service to stakeholders and industries. The conduct of such training ensures correct dissemination of policies, procedures, and guidelines implemented by the FDA.

The FDA Academy training sessions are designed to ensure that industry representatives nominated by regulated establishments have a thorough understanding of the FDA policies and regulations and the necessary knowledge to enable them to correctly prepare and submit registration applications. (more…)

2019-05-02T09:29:18+08:00 May 2nd, 2019|Insight, Medical Regulation Updates, News & Events|

Thailand: MDA 2019 – The International Exhibition and Conference on Medical Device Technologies, Service Solutions and General Healthcare

MDA 2019

Medical Devices ASEAN 2019 (MDA 2019) positions Thailand as a hub for medical devices and the focal point for medical academics in the ASEAN region.

MDA 2019, an international exhibition and conference on medical device technologies, service solutions and general healthcare, serves as a key meeting place for medical device and healthcare professionals to gain the latest updates, techniques, and knowledge, to network and do business.

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2019-05-02T09:56:59+08:00 May 2nd, 2019|Event, News & Events|

Malaysia: Notification on Medical Devices for Special Access

special access

On 8th April 2019, the Medical Device Authority (MDA) in Malaysia released a first edition guidance document, “Notification on Medical Devices for Special Access”.

Under the Medical Device (Exemption) Order 2016, medical devices for special access are exempt from registration with the MDA. Medical devices that meet the following criteria are eligible for special access status and can apply via the Notification route:

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2019-05-02T05:30:57+08:00 May 2nd, 2019|Medical Regulation Updates, News & Events|

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|