August 13, 2018
For the registration of any medical device with most regulatory authorities around the world, the first step would be to prepare the device’s technical documentation or a dossier. Technical documentation are the documented evidence, normally an output of the quality management system, which demonstrates conformity of a device to the Essential Principles of Safety and Performance (EPSP) of Medical Devices. Manufacturers of all Classes of General and In Vitro Diagnostic medical devices are expected to demonstrate conformity of the medical devices to the EPSP of Medical Devices through the preparation and holding of technical documentation that shows how each medical device was developed, designed and manufactured together with the descriptions and explanations necessary to understand the manufacturer’s determination with respect to such conformity.
However, a prevalent issue found in the preparation and submission of technical documentation with regulatory authorities (RA) around the world had been the irregularity of this dossier format. Each country’s RA had a different format in place for this dossier, which meant there was no harmonization of the documentation and procedures that are used to assess whether a medical device, including IVD medical device conforms to the regulations that apply in each jurisdiction. Eliminating differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments. In order to rectify this situation, the Global Harmonization Task Force (GHTF) (now known as the IMDRF) proposed and implemented a harmonised technical documentation template, known as the Summary of Technical Documentation (STED).
The STED template is widely accepted by RAs all over the world, except when there is a slightly different technical documentation template implemented in certain countries. This is where the ASEAN Common Submission Dossier Template (CSDT) comes into place. The ASEAN CSDT was introduced and implemented in 10 ASEAN countries by the ASEAN Medical Device Directive (AMDD). It contains elements of the GHTF STED but bears differences in other aspects. We shall take a look at what makes up these differences between an STED and a CSDT.
What is an STED?
Summary of Technical Documentation (STED) is a set of technical documentation that follows a harmonised template set by the GHTF (now known as IMDRF), which is widely accepted by most RAs around the globe. It allows the RAs to conduct conformity assessment of the medical devices, according to local and international standards set in place. Manufacturers assemble the STED from existing technical documentation to provide evidence to the RA or Conformity Assessment Body (CAB) that the subject medical device is in conformity with the Essential Principles. The STED reflects the status of the medical device at a particular moment in time (e.g. at the moment of premarket submission or when requested by a RA for post-market purposes) and is prepared in order to meet regulatory requirements. This technical documentation is constantly revised to reflect the current status of the medical device through normal application of the manufacturer’s QMS. Where the STED is submitted to a RA/CAB, it should be in a language acceptable to the reviewing organisation.
STEDs are required to contain summary information on selected topics, and may contain detailed information on certain specific topics and an Essential Principles checklist. The information provided may include, for example, abstracts, high level summaries, or existing controlled documents, as appropriate, sufficient to communicate key relevant information and allow a reviewer to understand the subject and assess the validity of that information.
Getting to know the CSDT
On the other hand, Common Submission Dossier Template (CSDT) is used by only the 10 ASEAN countries, following the implementation of the ASEAN Medical Device Directive (AMDD). The AMDD agreement was signed in 2015 by all the 10 ASEAN countries – Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam. The agreement is expected to come into full effect starting 2020, with many of these member states already adapting the directive into regulating their own medical device industry.
The idea of having AMDD implemented by ASEAN members is to harmonize medical device regulations and common technical documents to ease the placement of medical devices in ASEAN countries, not dissimilar to current European practice i.e., CE marked devices can be placed across Europe. The ASEAN CSDT document is intended to provide a common template for the submission of medical device information to medical device regulatory authorities of ASEAN member countries. Product registration applications for medical devices submitted to ASEAN Member States (AMS) must be prepared in the format set out in the CSDT document.
The content of the CSDT resembles the STED, in terms of the compilation of summary information on selected topics, and inclusion of detailed information on other specific topics and an Essential Requirements checklist. However, the depth of details to be covered by these topics differ between the STED and CSDT, including the format of certain administrative documents to be submitted.
Comparison of the STED and CSDT
The core content of each document is the required content of the technical documentation to be submitted to a regulatory authority. In this respect, the CSDT is more detailed than the STED for medical devices.
The CSDT incorporates the requirements for labelling and instructions for use, as well as for clinical evidence. The GHTF includes these requirements as headings only, with the detailed requirements included in separate guidance documents.
Table 1: Overview of Differences Found between the CSDT and STED
Apart from the above mentioned aspects, the other aspects of the STED and the CSDT use the same set of technical documents, albeit in different arrangements. The final format of compiling a STED and a CSDT can be consulted in their respective guidance documents as referenced below.
Without proper formatting, the most meticulously researched and prepared medical device market application can fail to pass regulatory review, costing the applicant time and money. In this article, Qualtech breaks down the differences between the formats of STED and CSDT. Keep a lookout for a Part 2 focusing on a comparative article between the STED and China National Drug Administration (CNDA) in next month’s QT Newsletter edition.
1) Study Group 1 of the Global Harmonization Task Force (2011). Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices
2) ASEAN Medical Device Product Working Group (2010). Guidance on Preparation of a Product Registration Submission for General Medical Devices using the ASEAN Common Submission Dossier Template