Specifications for medical devices

What are the specifications for a medical device?

So, let's first understand the difference between technical specifications and an organization standard. Technically, they are one and the same thing. Both are a document regulating quality. Both are a set of requirements and methods. Such documents are developed by the manufacturer of medical devices and medical equipment to set internal requirements for the manufacturing process and quality control of a product. In Kazakhstan it is called Standard of Organization or ST LLP, while the name "Technical Conditions" or TU is a formulation of other countries. This is the name of a normative document in Russia, for example, or in Ukraine and Belarus. In fact, ST LLP is a TU, but with differences in execution. Technical specifications for medical devices must be developed and agreed upon in the manner prescribed by law. That is, there are requirements for the design of TU for medical devices, as well as it is important to comply with the order in the structure of the TU. Many people entrust the development to consulting companies (lcs-kz), this is also an option, but the process should be a collaborative one, involving the manufacturer.

Development of technical specifications for medical devices

The very development of technical specifications for medical products is based on already existing international or other requirements. What does this mean? Let's say you decide to produce bandages. But not from gauze, but from a new, unparalleled material. There is already a standard for ordinary gauze bandages. For Kazakhstan, for example, the interstate GOST 1172 will do. Yes, it is old, but it has the status of valid. How can we understand whether it is suitable for Kazakhstan or not? Kazakhstan is on the list of states that approved its adoption. This document states that if we make bandages from gauze, it has certain requirements. The gauze must be of the quality that GOST wants. But you have a different case. You have gauze, say, with an admixture of high-tech raw materials in its composition, and its properties do not fit into the requirements set by GOST. You need to draw up your own Standard of Organization. Or technical specifications. There you will specify everything that relates to your product. Properties of unique raw materials, evidence of its effectiveness. And even, perhaps, offer the market more convenient sizes of the finished product than already exist.

Structure of technical specifications

How the structure of TU for medical products or ST LLP looks like is fully set out in a special standard. For Kazakhstan it is ST RK 1.5, which gives clear regulations on how such a standard for a product should be drawn up and formalized. There are sections of technical specifications for medical or other products. To facilitate the task, you can download a sample of technical specifications for medical products. They are often available in the public domain. However, you need to pay attention to which country the standard is drawn up for. Since, the regulation in this regard is different for everyone, then the requirements for drafting are different. When developing, of course, it is necessary to take into account that if the country has already adopted a national or other regulatory standard for exactly the same product, you can not ignore it. The basic requirements for raw materials and the finished product must be taken into account when drafting. Let's remember the case of classic bandages. If you produce them from classical gauze, but want to offer just other sizes of finished bandages, your ST LLP must contain mandatory requirements from the GOST for bandages to the quality of the same gauze. 

TU approval

In most cases, such documents require approval and certification by a state authority. For example, in Russia, technical specifications for medical equipment and products must be approved by a special accredited body, and a mark is placed on the technical specification itself. Only after that the normative document is recognized as legitimate and can be submitted to the dossier for registration. Earlier in Kazakhstan there was also such a practice. However, now the manufacturer itself has the right to develop and approve the terms and conditions, without further approval from the state. That is, the responsibility for this document falls entirely on the domestic producer.

How to use technical specifications

The finished standard of the organization looks so that any quality control laboratory can understand it. And also an expert body, of course. The document must show for which products it is designed, in what range and version they will be presented on the market, as well as the permissible configuration and conditions of use and storage. In addition, there are clear requirements for packaging and labeling, regulatory documents from which the information is taken, as well as the frequency and format of testing. And of course, the most important information - what the product is made of, how the raw materials are safe and what it is - the finished product. That is, its description, dimensions, functionality. How to check these requirements is necessarily described in the test methods. The methods must also contain the conditions for conducting tests and information about the equipment on which all this will be tested. 

We provide the signed, approved and tested standard to laboratories during technical or other tests, to the state body as part of the dossier for registration of medical devices or on request, as well as use it ourselves when manufacturing products. 

Introduction of changes to specifications

An organization's standard requires constant attention and cannot just gather dust on a shelf. The document changes with your product, with legislation and with the conditions of the production or technological process. Changes to the standard are made officially, in accordance with the rules adopted in your quality management system. That is, when used, the standard must contain all changes and be up to date.