Regulatory updates Archives

Laboratory technician processing PCR C*vid-19 tests

Vietnam: Ministry of Health issues Circular No. 06/2022/TT-BYT: List and issuance of registration numbers of medical devices intended for COVID-19 pandemic prevention and control in emergency cases

August 12, 2022

With the emergence of COVID-19 pandemic, the Ministry of Health is continuing its effort to control the epidemic by adjusting its regulations. On August 1, 2022, the Ministry of Health has issued Circular No. 06/2022/TT-BYT defining the list and issuance of registration numbers of medical devices intended for COVID-19 pandemic

Doctor in hazmat ppe checkin patients temperature

Vietnam: Ministry of Health issues Circular 05/2022/TT-BYT: Regulating in detail the implementation of some articles of Decree 98/2021/ND-CP on Management of Medical Devices

August 10, 2022

On August 1, 2022, the Vietnamese Ministry of Health issued Circular 05/2022/TT-BYT, regulating in detail the implementation of some articles of Decree 98/2021/ND-CP on Management of Medical Devices. This circular contains the following details: A. Supplement the list of in vitro diagnostic medical device that is not subject to quality

Indonesia: Substitution of Imported Medical Devices with Domestic Medical Devices in the sectoral e-Catalogue

August 10, 2022

Indonesia’s government through the Ministry of Health continues to support the usage of locally manufactured medical devices, especially the ones purchased via e-Catalogue by national hospitals. This campaign is stated under Instruction President No. 2-year 2022, which instructs the Ministry of Health to update the policies in accelerating and increasing

Malaysia: MDA launches MEDICAL DEVICE CENTRALIZED REPORTING SYSTEM (MEDCREST)

July 18, 2022

On July 14th 2022, the MDA announced Medical Device Centralized Reporting System (Medcrest) is ready to be used by an establishment of a medical device. All Mandatory Problem Reporting, Field Corrective Action and Device Recall can be done online using the Medcrest system starting July 15th, 2022. This new system

Laboratory test using test tubes / in-vitro devices (IVD)

Singapore: HSA Released Draft Regulatory Guidelines for Laboratory Developed Tests (LDTs)

July 18, 2022

Health Sciences Authority (HSA) Singapore has published a new guidance document ‘Regulatory Guidelines for Laboratory Developed Test (LDTs)’ which is opened for public consultation with industry stakeholders, from 12 Jul 2022. LDTs are considered in vitro diagnostic tests (IVDs) as defined in Health Product (Medical Device) (HP(MD)) Regulations. The scope

Philippines: FDA Released An Amendment To FDA Circular No. 2017-013, Entitled, “Guidelines On The Issuance Of Clearance For Customs Release (CFCR) Of Radiation Devices By The Food And Drug Administration – Center For Device Regulation, Radiation Health, And Research (FDA-CDRRHR)

July 18, 2022

On June 30, 2022, the Philippine Food and Drug Administration has issued FDA Circular No 2017-013-A entitled, “AMENDMENT TO FDA CIRCULAR NO. 2017-013, ENTITLED, GUIDELINES ON THE ISSUANCE OF CLEARANCE FOR CUSTOMS RELEASE (CFCR) OF RADIATION DEVICES BY THE FOOD AND DRUG ADMINISTRATION – CENTER FOR DEVICE REGULATION, RADIATION HEALTH,

Regulatory Updates

Regulatory Updates

Vietnam: Ministry of Health issues Circular No. 06/2022/TT-BYT: List and issuance of registration numbers of medical devices intended for COVID-19 pandemic prevention and control in emergency cases

Vietnam: Ministry of Health issues Circular 05/2022/TT-BYT: Regulating in detail the implementation of some articles of Decree 98/2021/ND-CP on Management of Medical Devices

Indonesia: Substitution of Imported Medical Devices with Domestic Medical Devices in the sectoral e-Catalogue

Malaysia: MDA launches MEDICAL DEVICE CENTRALIZED REPORTING SYSTEM (MEDCREST)

Singapore: HSA Released Draft Regulatory Guidelines for Laboratory Developed Tests (LDTs)

Philippines: FDA Released An Amendment To FDA Circular No. 2017-013, Entitled, “Guidelines On The Issuance Of Clearance For Customs Release (CFCR) Of Radiation Devices By The Food And Drug Administration – Center For Device Regulation, Radiation Health, And Research (FDA-CDRRHR)

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Regulatory Updates

Regulatory Updates

Vietnam: Ministry of Health issues Circular No. 06/2022/TT-BYT: List and issuance of registration numbers of medical devices intended for COVID-19 pandemic prevention and control in emergency cases

Vietnam: Ministry of Health issues Circular 05/2022/TT-BYT: Regulating in detail the implementation of some articles of Decree 98/2021/ND-CP on Management of Medical Devices

Indonesia: Substitution of Imported Medical Devices with Domestic Medical Devices in the sectoral e-Catalogue

Malaysia: MDA launches MEDICAL DEVICE CENTRALIZED REPORTING SYSTEM (MEDCREST)

Singapore: HSA Released Draft Regulatory Guidelines for Laboratory Developed Tests (LDTs)

Philippines: FDA Released An Amendment To FDA Circular No. 2017-013, Entitled, “Guidelines On The Issuance Of Clearance For Customs Release (CFCR) Of Radiation Devices By The Food And Drug Administration – Center For Device Regulation, Radiation Health, And Research (FDA-CDRRHR)

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Main Pages

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