The document describes in detail the aspects to be taken into account when preparing a site master file.
Table of Contents
Introduction
The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the preparation of a site master file for licensing. The document provides an overview of the applicable regulatory requirements, as well as additional recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to provide additional clarifications based on the existing legislation. The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding changes to the underlying regulations. Furthermore, the authority also mentions that in case of any discrepancies with provisions of the current legislation, the latter should prevail.
Regulatory Background
The present guidance is intended to provide additional clarifications and recommendations regarding the regulatory matters related to a Site Master File (SMF), which stands for a document prepared by the company containing specific and factual Good Distribution Practice for Medical Devices (GDPMDS) information about the storage, distribution, deliveries and secondary assembly operations carried out at the named side. In this respect, the authority also mentions that if only a number of these operations are carried out at this site, the SMF only needs to describe those particular activities, e.g., storage. According to the guidance, its scope covers all the parties involved in operations with medical devices in the country including medical device manufacturers, importers, suppliers, and wholesalers.
Terms and Definitions
First of all, the document provides a definition of an important term used in the context of the guidance – secondary assembly – defined as the process of repackaging a medical device from its original packaging into another packaging, without breach of the primary packaging, before the medical device is sold or supplied.
SMF Submission: Approach to be Applied
The guidance further explains how and when a site master file should be submitted. In particular, the document emphasizes the following:
- The said document should be issued in English with the overall volume not exceeding 20 sheets (A4). It should also have an edition number and an effective date.
- In order to improve the overall clarity of the document, plans and drawings should be used instead of plain text, provided they fit paper of the above format.
- Each time the changes are made, they should be reflected properly in the site master file. At the same time, it should be submitted only if explicitly requested by the authority. If requested, it should be submitted in electronic format (.doc or .pdf) with a file size not exceeding 2 MB.
SMF Content
In order to assist the parties involved in following the approach described herein and ensuring compliance with the applicable regulatory requirements, the authority also provides additional clarifications regarding the content of a Site Master File to be prepared by an entity conducting operations with medical devices. According to the guidance, an SMF should contain:
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- General information about the site in question, including its name and address, connections to other sites, and other relevant details. The appropriate brief description should not exceed 250 words. In this section, the details about any licenses or authorizations granted should also be included, together with the information about other activities carried out on the site. According to the document, the details to be reflected in this section also include:
- Name and exact address of the site, including telephone and fax numbers,
- Type of medical devices handled on the site and information about specifically toxic or hazardous substances handled, mentioning the way they are handled and precautions taken,
- Short description of the site (size, location, immediate environment, and other activities on the site),
- Number of employees engaged in administration, warehousing, distribution, transportation, and secondary assembly,
- Use of outside administrative or other technical assistance in relation to other operations,
- Short description of the quality management system of the company.
- Personnel-related details should also be included in an SMF. In particular, the authority expects the entity to include an organization chart with all the key personnel reflected, the details on their qualifications and experience, as well as on training and relevant record-keeping.
- Premises and facilities. In terms of the premises and facilities used in the relevant processes, the document should include the following details:
- Simple layout plan and description of warehousing areas with an indication of scale,
- Brief description of ventilation systems,
- Special areas for handling highly toxic, hazardous, and sensitizing materials,
- Maintenance,
- Availability of written specifications and procedures for cleaning the areas,
- Policy on the storage of medical devices.
- Stock handling and stock control should be addressed in a separate section of the document. In particular, the authority expects the matters reflected to include:
- Details on the distribution system and recording associated thereto,
- Transportation and delivery.
- General information about the site in question, including its name and address, connections to other sites, and other relevant details. The appropriate brief description should not exceed 250 words. In this section, the details about any licenses or authorizations granted should also be included, together with the information about other activities carried out on the site. According to the document, the details to be reflected in this section also include:
Apart from the abovementioned matters, the ones to be addressed in an SMF also include documentation, complaints handling procedures, field safety corrective actions, as well as internal audits.
In summary, the present HSA guidance provides additional clarifications regarding the existing regulatory requirements with respect to Site Master Files to be maintained by the parties involved in operations with medical devices. The document describes in detail the content of the said document and highlights specific points to be considered.
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