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MALAYSIA: MDA Announced the Fifth Edition on the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products – March/April 2023

MALAYSIA: MDA Announced the Fifth Edition on the Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products – March/April 2023

  • 2023-03-27 09:16:15

The Medical Device Authority (MDA) published the Fifth Edition Guidance Document, "Guideline for Registration of Drug-Medical Device and Medical Devie-Drug Combination Products", on January 03, 2023. This document is intended to provide information on how to apply for an endorsement letter, post-approval changes/variation applications for ancillary components, adverse drug reactions and incident reporting for the registered combination product.

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PHILIPPINES: Updated Draft Guidelines for Availing Compassionate Special Permit for the Restricted Use of Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices – March/April 2023

PHILIPPINES: Updated Draft Guidelines for Availing Compassionate Special Permit for the Restricted Use of Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices – March/April 2023

  • 2023-03-27 08:52:43

PFDA presented a draft of the updated guidelines on obtaining a special permit for restricted use of unregistered drug and medical device products. In addition to previous patient conditions laid out by previous regulations, this new guidance widens the product scope to vaccines and the diseases to include those that may result in the patient's permanent disability.

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USA: US FDA's eSTAR Program – March/April, 2023

USA: US FDA's eSTAR Program – March/April, 2023

  • 2023-03-27 08:22:41

The US FDA starts to launch the so-called "eSTAR" Pilot with Health Canada. The eSTAR is an interactive medical device submission process and is expected to likely become the main path regarding medical device submissions for 510(k) and De novo registrations in the near future.

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Social Responsibility: Funding impoverished children in China

Social Responsibility: Funding impoverished children in China

  • 2022-09-27 07:33:24

In 2000, Qualtech was established in Taipei. Since then, Qualtech has established several locations around the world. Over the years, Qualtech has always insisted on providing high-quality medical equipment services such as regulatory consultation, product registration, clinical design and implementation, local authorized registration, and post-market surveillance. In addition to providing professional services, we also do not forget the social responsibility that belongs to Qualtech. Since Qualtech is engaged in the medical-related industry, we focus more on helping and caring for underprivileged groups.

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