Developing Harmonized Guidelines for Medial Device Submissions in Asia

The Asian Harmonization Working Party (AHWP) has recently drafted a “Common Submission Dossier Template” (CSDT). If adopted, this would allow medical device companies to use one common form when submitting to any of the 13 countries in the AHWP. By adopting this document, the AHWP hopes to further streamline the registration process by eliminating the need to prepare multiple dossiers. The AHWP consists of representatives of Brunei, China, Hong Kong, Indonesia, South Korea, Malaysia, the Philippines, Singapore, Taiwan, Thailand, Vietnam, Saudi Arabia and South Africa.

The CSDT contains elements of the Summary Technical Documentation (STED). It was created by combining the common registration requirements for each member country, with basic information such as device description, design verification, and validation data. It was done in the hope of allowing demonstration to conformity for medical devices of all classes in the least troublesome manner.

In addition to filing the common dossier, an executive summary would also be required. This document would include the following:

  • An overview of the medical device, with description, intended use, and indications
  • Commercial marketing history
  • Intended uses and indications in labeling
  • List of regulatory approvals or marketing clearances obtained
  • Status of any pending requests for market clearance
  • Important safety and performance data

The template would apply to all medical devices as defined by the Global Harmonization Task Force. The AHWP is also proposing to include in-vitro diagnostic (IVD) products in this category.

The AHWP is currently seeking comments on the proposed document until January 31, 2007.