Regulatory updates Archives

Philippines: Draft for Comments on the Recognition of Accredited Technical Service Providers for Radiation Dosimetry of Individual Monitoring Services

September 25, 2023

The Philippines FDA is seeking comments from the stakeholders on the Draft Guidelines for the Recognition of Accredited Technical Service Providers for Radiation Dosimetry of Individual Monitoring Services. All comments shall be sent as “.doxc” or “.pdf” to cdrrhr.rrd@fda.gov.ph or comment sheet may be accessed here. This guideline aims to

Singapore: HSA Published List of Standards for Medical Devices

September 22, 2023

Recognized standards are often used to demonstrate conformity to the Essential Principles of Safety and Performance of Medical Devices. On September 05, 2023, the Health Sciences Authority (HSA) of Singapore published a list of recognized standards for medical devices. This list matches the nationally recognized Singapore Standards (SS) against that

Singapore: HSA Safety Monitoring and GDPMDS Guidance Documents Update

September 22, 2023

HSA Safety Monitoring and GDPMDS Guidance Documents Update On September 08, 2023, the Health Sciences Authority (HSA) of Singapore published updates to related safety guidance documents as well as GDPMDS document, as follows: • GN-05: Guidance on Reporting of Adverse Events for Medical Devices Revision 3 • GN-07: Guidance on

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Thailand: Amendment on The Format of The Establishment Registration Certificate for Medical Device Manufacturers and Importers

September 21, 2023

The Thailand Food and Drug Administration (FDA) announced an amendment to the format of establishment registration certificate for medical device manufacturers and importers. This announcement was in line with the newly issued regulations dated 30 August 2023, as follows: Ministerial Regulation Establishing the Criteria, Procedures, and Conditions for the Registration

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Philippines: Pilot Implementation of Customer Relation Management Information System (CRMIS) by the Philippines FDA

September 12, 2023

The Philippines FDA has issued Advisory No. 2023 – 1881 entitled “Pilot Implementation of the Food and Drug Administration Customer Relation Management Information System (CRMIS) which is an digital platform that will allow stakeholders and general public to submit inquiries, follow – ups, and other concerns via this link http://contact.fda.gov.ph/

Indonesia’s Government Issued a New Regulation Pertaining to Health

September 11, 2023

Indonesia’s government has officially issued Law No. 17 of 2023 concerning Health which comes into effect on 8 August 2023. At the time this new regulation came into force, the previous Law No. 36 of 2009 concerning Health was revoked and declared invalid. In general, Law No. 17 of 2023

Regulatory Updates

Regulatory Updates

Philippines: Draft for Comments on the Recognition of Accredited Technical Service Providers for Radiation Dosimetry of Individual Monitoring Services

Singapore: HSA Published List of Standards for Medical Devices

Singapore: HSA Safety Monitoring and GDPMDS Guidance Documents Update

Thailand: Amendment on The Format of The Establishment Registration Certificate for Medical Device Manufacturers and Importers

Philippines: Pilot Implementation of Customer Relation Management Information System (CRMIS) by the Philippines FDA

Indonesia’s Government Issued a New Regulation Pertaining to Health

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Regulatory Updates

Regulatory Updates

Philippines: Draft for Comments on the Recognition of Accredited Technical Service Providers for Radiation Dosimetry of Individual Monitoring Services

Singapore: HSA Published List of Standards for Medical Devices

Singapore: HSA Safety Monitoring and GDPMDS Guidance Documents Update

Thailand: Amendment on The Format of The Establishment Registration Certificate for Medical Device Manufacturers and Importers

Philippines: Pilot Implementation of Customer Relation Management Information System (CRMIS) by the Philippines FDA

Indonesia’s Government Issued a New Regulation Pertaining to Health

Countries

Categories

Sign up for our regulatory roundup delivered once a month to your inbox

Main Pages

Address

E-mail Address

Phone Number

Main Pages

Address

E-mail Address

Phone Number

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