Regulatory updates Archives

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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,

Medical Device Professional submitting reports online

Philippines: Reminder on the Submission of Financial Reports through the FDA Online Disclosure Reporting System

July 15, 2022

The Philippines Food and Drug Administration is reminding all FDA-licensed manufacturers, traders, repackers, distributor-importers, and distributor-wholesalers of drug, medical devices, and biological products, including vaccines, and medical supplies to submit their disclosure reports related to financial relationships with healthcare providers and healthcare professionals, pursuant to Section 35 (b) of RA

Regulatory Updates

Regulatory Updates

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)

Philippines: Reminder on the Submission of Financial Reports through the FDA Online Disclosure Reporting System

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Regulatory Updates

Regulatory Updates

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)

Philippines: Reminder on the Submission of Financial Reports through the FDA Online Disclosure Reporting System

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Main Pages

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