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
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
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,
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
MDA would like to inform that the Medical Device (Responsibility & Establishment) Regulations 2019 will be fully enforced, effective July 1, 2022. With the full enforcement of these rules, it means that all parties involved in the importation, distribution, and placement of medical devices in the market are required to
On 22 June 2022, Malaysia’s Medical Device Authority (MDA) has released The Fifth Edition Guidance for Labeling on Registered Medical Devices. The purpose of the document is to provide guidance to manufacturers and authorised representatives on the content of medical device labelling. This amendments from the fourth edition to fifth
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