July 2022

We’re Hiring – Human Resource Manager

Andaman Medical is a young and fast-growing Medical Device Regulatory Affairs & Market Access consultancy. We specialize in the registration, authorized representation, importation, master distribution, quality assurance and compliance of medical device and in-vitro diagnostics (IVD) in Southeast Asia. Our clients are among the world’s leading Medical Device and IVD Manufacturers. Our dedicated experts are …

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Nurse operating medical device

Malaysia MDA launches MEDICAL DEVICE CENTRALIZED REPORTING SYSTEM (MEDCREST)

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 can be accessed through the …

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

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

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 of the new guidance encompasses …

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Patient having an xray

The 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)

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, AND RESEARCH (FDA-CDRRHR)”. This Circular …

The 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) Read More »

Medical Device Professional submitting reports online

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

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 No. 11223 Ethics in Public …

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Medical device paperwork

Full Enforcement Announcement of Medical Device Regulations (Responsibility & Establishment) 2019

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 comply with all the post-market …

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Team labelling medical devices

Malaysia’s Medical Device Authority Releases Fifth Edition of Requirements for Labelling of Medical Devices

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 edition are as follows: Clause …

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Medical labelling

MDA Provides Transition Period For Compliance With The Requirements Of Labelling Of The Medical Devices (MDA/GD/0026, Fifth Edition)

The MDA has informed the public that they will give transition period until 31 December 2022 to the establishment for compliance with the requirements set out in the guidance document “Requirements for Labelling of Medical Devices (MDA/GD/0026), Fifth Edition”. To ensure that the importation and distribution of medical device could be carried out smoothly, the …

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Medical device exhibition

Guidance For Importation Of Unregistered Medical Devices For Exhibition In Singapore

On 29 June 2022, Health Sciences Authority (HSA) Singapore published an update to guidance document, GN-32 GUIDANCE FOR IMPORTATION OF UNREGISTERED MEDICAL DEVICES FOR EXHIBITION IN SINGAPORE Revision 4. Regardless of risk class, unregistered medical devices (human use) for exhibition, are subjected to regulatory controls under the Singapore’s law. Applicants are required to obtain an …

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