Regulatory updates Archives

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

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

July 11, 2022

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

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

July 11, 2022

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

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

July 6, 2022

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

Singapore: Guidance For Importation Of Unregistered Medical Devices For Exhibition In Singapore

July 6, 2022

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

Regulatory Updates

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

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

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

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

Singapore: Guidance For Importation Of Unregistered Medical Devices For Exhibition In Singapore

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