The Therapeutic Goods Administration (TGA) Australia has published the latest document on the reclassification of active implantable medical devices (AIMD) with information on transitional arrangements and obligations, in March 2022.
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Regulatory News
NPRA Malaysia Publishes Frequently Asked Questions on Medicinal Gases
National Pharmaceutical Regulatory Agency (NPRA) Malaysia has issued a set of frequently asked questions (FAQs) on medicinal gases in February 2022.
The document provides detailed information on the questions and answers
read more...Singapore HSA Publishes Guidelines on Voluntary Electronic Labelling for Complementary Health Products
The Health Sciences Authority (HSA) Singapore has published a guidance document on voluntary electronic labelling for complementary health products (CHP) in March 2022.
Electronic labelling, also known as e-labelling, is information
Hong Kong Drug Office Publishes Guidance Notes on Registration of Pharmaceutical Products
Hong Kong Drug Office has published some guidance notes on the requirements of pharmaceutical products in February 2022.
Registration of pharmaceutical products needs to be completed before being sold in Hong
Singapore HSA Publishes Revised Guidance on Health Supplements Guidelines
The Health Sciences Authority (HSA) Singapore has published the latest guidance document on health supplements in March 2022.
The working definition of health supplements has been updated to be in accordance
Australia TGA Publishes Information on Regulation Essentials
The Therapeutic Goods Administration (TGA) Australia has published a general overview of the regulatory process, along with information about relevant resources.
The TGA is involved with the regulation of therapeutic goods
Hong Kong Drug Office Publishes Information on Requirement of Elemental Impurities Levels or Limits
Hong Kong Drug Office has published a guideline on the requirement of elemental impurities levels or limits in registered pharmaceutical products in February 2022.
As stipulated in the International Council for
MDA Malaysia Publishes Guidance Document on Refurbished Medical Devices
The Malaysian Medical Device Authority (MDA) has published a guidance document on the requirements for refurbished medical devices in January 2022.
The guidance will be able to assist manufacturers and authorised
read more...Singapore HSA Publishes Revised Guidance on Grouping of Medical Devices for Product Registration
The Health Sciences Authority (HSA) Singapore has published the latest guidance document on the grouping of medical devices for product registration, with details on device specific grouping criteria, in January
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