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|