Medical device manufacturing analytics
1. Definition and types
Medical equipment is a type of medical devices.
In the current legislation of the Russian Federation medical devices are understood as any instruments, apparatus, devices, equipment, materials and other products used for medical purposes separately or in combination with each other, as well as together with other accessories necessary for the use of these products for their intended purpose, including special software, the functional purpose of which is not realized through pharmacological, immunological, genetic or metabolic effects on the human body (article 38 of the Federal Law of the Russian Federation).
In the most generalized form, medical equipment should be understood as devices, apparatuses or complexes of equipment used for diagnosis, treatment, prevention, health monitoring or rehabilitation.
The legislation of the Russian Federation contains an indication of a large number of different types of medical equipment, in particular, the following types:
1. Diagnostic equipment - used to detect diseases and monitor the patient's condition:
- Ultrasound machines;
- X-ray machines;
- MRI (magnetic resonance imaging);
- CT (computerized tomography);
- ECG (electrocardiographs);
- Glucometers;
- Analyzers (hematological, biochemical, immunological);
2. laboratory equipment - used for research of biological samples:
- Microscopes;
- Centrifuges;
- Spectrophotometers;
- Thermostatic chambers;
- Automatic analyzers of blood, urine and other liquids;
3. therapeutic equipment - used for therapeutic procedures:
- Laser devices;
- Apparatuses for physiotherapy;
- Ventilators (artificial ventilation machines);
- Defibrillators;
- Infusion pumps (syringe and peristaltic);
- Dialysis machines;
4. surgical equipment - designed for surgical interventions:
- Surgical lamps;
- Electrosurgical generators;
- Endoscopic racks;
- Laparoscopic equipment;
- Sterilizers;
- Anesthesia machines;
5. Resuscitation and intensive care equipment - equipment to support and restore vital functions:
- Patient monitors;
- Pacemakers;
- Ventilators;
- Aspirators and suction;
- Hyperbaric oxygenation equipment;
6. Rehabilitation equipment - used to restore body functions:
- Exercise machines for physical therapy;
- Apparatus for massage;
- Orthopedic devices (exoskeletons, walkers, wheelchairs);
- Electrostimulators;
7. Dental equipment - for diagnostics and treatment of teeth:
- Dental units;
- Intraoral X-ray devices;
- Laser systems;
- Equipment for prosthetics;
8. Portable and handheld equipment - for medical care outside of medical facilities:
- Portable ECGs;
- Defibrillators;
- Diagnostic monitors;
- Compact ultrasound scanners;
9. Specialty equipment - for specific medical tasks:
- Radiation therapy equipment;
- Apparatus for cryotherapy;
- Equipment for robotic surgery.
Meanwhile, despite the specific type of medical equipment, the current legislation imposes many requirements for its production and entry into circulation for the purpose of further operation.
2. Legal regulation and regulatory requirements
The main legal act regulating the requirements for the production and circulation of medical equipment is Federal Law No. 323-FZ of 21.11.2011. “On the Fundamentals of Health Protection of Citizens in the Russian Federation”.
But most of the requirements are enshrined in bylaws. For example, such as:
- Resolution of the Government of the Russian Federation from 27.12.2012 № 1416 “On approval of the Rules of state registration of medical devices”;
The Resolution establishes the rules of state registration of medical devices, the procedure for expert examination of their quality, efficiency and safety.
- Resolution of the Government of the Russian Federation of 30.06.2021, No. 1066 “On federal state control (supervision) over the circulation of medical devices”;
The regulatory legal act establishes the procedure for state control over the circulation of medical devices, including their commissioning.
- Decision of the Customs Union Commission from 28.05.2010 № 299 “On the application of sanitary measures in the Eurasian Economic Union”;
The document establishes sanitary requirements for medical equipment, including requirements to ensure their safety and effectiveness.
- Order of the Ministry of Health of Russia No. 724n dated 15.10.2015 “On Approval of a Model Contract for the Supply of Medical Devices, Commissioning of Medical Devices, Training of Specialists Operating Medical Devices and Specialists Performing Maintenance of Medical Devices”;
The order regulates the procedure for supplying, commissioning and training personnel to work with various types of medical equipment.
- Order of the Ministry of Health of the Russian Federation from 19.01.2017 № 11n “On approval of requirements for the content of technical and operational documentation of the manufacturer (manufacturer) of a medical device”;
The Order approves requirements for the content of technical and operational documentation of the manufacturer (producer) of medical equipment of various types.
- Order of the Ministry of Health of Russia from 30.08.2021 No. 885n “On Approval of the Procedure for Conformity Assessment of Medical Devices in the Form of Technical Tests, Toxicological Studies, Clinical Tests for the Purposes of State Registration of Medical Devices”;
Establishes the procedure for all tests for the purposes of state registration of medical devices.
- Order of the Ministry of Health of Russia No. 980n of 15.09.2020 “On Approval of the Procedure for Monitoring the Safety of Medical Devices”;
The order establishes the procedure for monitoring the safety of operation and use of medical equipment.
- Order of the Ministry of Health of Russia of 19.10.2020, No. 1113n “On Approval of the Procedure for Reporting by Subjects of Circulation of Medical Devices”;
Establishes the procedure for notification of all cases of detection of adverse actions or other non-standard cases arising in the course of operation of medical equipment, especially those resulting in harm to human health or life.
The main groups of legislative requirements for the production, introduction into circulation and further operation of medical equipment should include the following:
- state registration of medical equipment;
- licensing of organizations performing technical maintenance of medical equipment;
- compliance with quality standards (GOST) and technical regulations;
- requirements to labeling and operational documentation;
- requirements for import and export of medical equipment;
- monitoring of safety and efficiency after medical equipment is put into operation.
It should be noted that from 01.01.2022 and currently medical equipment itself is subject only to state registration, and companies engaged in the production of medical equipment are not subject to licensing. Only organizations engaged in maintenance of medical equipment fall under the mandatory licensing procedure.
3. State registration procedure
The state body responsible for the registration of medical equipment in the Russian Federation is the Federal Service for Supervision of Health Care (Roszdravnadzor).
The procedure of state registration of medical equipment in the Russian Federation is aimed at confirming their quality, safety and effectiveness for use in practice.
The procedure of state registration of medical equipment includes the following stages:
Stage 1 - preparatory stage, submission of a package of documents;
The applicant forms a package of documents, including, in addition to the application itself and a receipt for payment of the state duty, the following:
- Technical documentation (drawings, schemes, passports for the equipment);
- Description of the device and principle of operation of the equipment;
- Manual on the operation of the equipment;
- Declaration or certificate of conformity of equipment standards (GOST, ISO);
- Documents confirming the quality and safety of materials used in the manufacture of equipment;
- Translation of documents into Russian (if the equipment is foreign);
The documents must comply with the requirements established for a particular type of medical equipment.
Stage 2 - testing;
2.1 Technical tests;
Technical tests are conducted to verify the compliance of medical equipment with the established technical characteristics, quality and safety standards.
Tests are conducted in special organizations accredited by Roszdravnadzor and include functional tests, electromagnetic compatibility, as well as testing for reliability and durability of medical equipment.
2.2 Toxicological tests;
These tests are performed on medical equipment that comes into contact with biological tissues or fluids.
In the case of medical devices, the absence of toxic elements in their components is verified and the biocompatibility of the materials used in the design is assessed.
2.3 Clinical trials;
The purpose of clinical testing is to evaluate the safety and effectiveness of the equipment under conditions of clinical use.
Clinical trials include tests on the use of specific medical equipment on patients under the supervision of specialists, as well as the collection of data on the effectiveness of such use and possible risks.
Stage 3 - making a decision on state registration or refusal to register;
Based on the results of expert examinations, Roszdravnadzor makes a conclusion on the safety, quality and effectiveness of a particular medical device.
Also at this stage, Roszdravnadzor checks the documents submitted for the medical equipment.
If Roszdravnadzor decides on state registration, a registration certificate is issued, and information about the medical equipment is entered into a special state register.
Stage 4 - post-registration supervision and control.
After state registration of medical equipment, the manufacturer has post-registration obligations.
The manufacturer is obliged to monitor the safety and effectiveness of the equipment in the process of its operation, and to report to Roszdravnadzor on any defects or adverse reactions identified.
The term of state registration of medical equipment in the Russian Federation depends on the class of potential risk of the product. According to the Resolution of the Government of the Russian Federation No. 1416 dated 27.12.2012, the following terms are established:
Class 1 (low risk) - registration is carried out within a period not exceeding 30 working days from the date of the decision to initiate state registration.
Class 2a, 2b, 3 (medium, increased and high risk, respectively) - registration is carried out within a period not exceeding 50 working days from the date of the decision to start state registration.
The timeframe may vary depending on the specifics of a particular medical device and the completeness of the documents submitted by the applicant. If necessary, Roszdravnadzor RF may request additional information or extend the deadline due to the need for additional tests (examinations).
The amount of state duty for registration of medical equipment in the Russian Federation depends on the class of potential risk of the product. According to Article 333.32.2 of the Tax Code of the Russian Federation, the following fee amounts are established:
Class 1 (low risk) - 72,000 rubles.
Class 2a (medium risk) - 104,000 rubles.
Class 2b (high risk) - 136,000 rubles.
Class 3 (high risk) - 184,000 rubles.
In addition, a fee of 11,000 rubles is charged separately for the issuance of a registration certificate.
4. requirements in production
The quality management system in the production of medical equipment is based on compliance not only with national GOST standards, but also with international standards ISO 13485:2016. The manufacturer must have an appropriate organizational structure in place, with a specific employee responsible for compliance with ISO requirements among the staff.
These requirements include the following:
1 - Compliance of production with technical regulations;
Medical equipment must comply with established technical regulations and standards to ensure its safety and effectiveness. Production must be subject to strict controls. Certain specifications must be established for each equipment, compliance with which must be monitored at each stage of production.
2 - Design and development processes;
The entire design process of medical device development consists of requirements analysis, conceptualization, verification and validation. In case of changes in the requirements, they are subject to operational implementation in the specific production.
3 - Documentation development and management;
Each stage of medical device production and start-up must be documented. For each stage of production, records shall be kept to confirm compliance with the requirements of the standards when requested by government agencies. There should be continuous internal auditing in the production facility.
4 - Supplier and raw material control;
The manufacturer shall evaluate suppliers to ensure the quality of all input materials used in the manufacture of medical devices. An incoming inspection shall be performed before specific raw materials are used in production.
5 - risk management;
The manufacturer shall analyze and manage the risks associated with the use of medical devices in accordance with ISO 14971. Risks shall be identified, their significance shall be assessed and specific measures to minimize them shall be developed.
6 - Management of non-conforming equipment;
When nonconforming equipment is found to have been produced, the manufacturer shall identify, record and analyze the causes of nonconformities and develop a specific list of corrective and preventive actions. Defective medical equipment shall be disposed of or recycled.
7 - Post-marketing surveillance.
After the release of medical equipment on the market, the manufacturer is obliged to monitor its use, collect information on possible adverse reactions and side effects of medical equipment use, and take measures to improve quality and safety.
5. Requirements for storage and transportation
Proper storage and transportation of medical devices are key aspects to ensure their safety, effectiveness and durability.
The basic requirements for medical equipment storage include:
1 - temperature guidelines;
Temperature recommendations should be formulated by the medical device manufacturer itself. Abrupt temperature fluctuations can adversely affect the functionality of the equipment.
2 - Humidity;
Optimal air humidity for storage and transportation of medical equipment should be up to 60% (up to 70% in certain climatic zones).
Higher humidity can lead to corrosion of metal parts and damage to electronic components of medical equipment, which can further affect its efficiency.
3 - Illumination;
Medical equipment should not be stored in direct sunlight, especially in the case of rubber or plastic products. Ultraviolet radiation can cause degradation of medical equipment.
4 - Ventilation;
The room where medical equipment is stored on a permanent basis should be well ventilated to prevent moisture accumulation and allow air circulation.
5 - Cleanliness;
When medical equipment is stored, regular damp cleaning should be carried out. It prevents the accumulation of dust and microorganisms.
6 - Placement.
Small equipment should be stored on racks or in cabinets, avoiding contact with the floor and walls. Bulk storage of medical equipment is not permitted. Each medical device should be packaged or placed according to its intended use.
Transportation of medical equipment shall be realized in compliance with the following requirements:
1 - transportation conditions;
Specific conditions of transportation shall be established by the direct manufacturer of the medical device. The carrier must comply with the temperature and humidity conditions recommended by the manufacturer, especially for sensitive equipment. Some types of equipment require a certain constant temperature to be maintained even during transportation.
2 - packaging;
Packaging specially designed for medical devices must provide protection against mechanical damage, moisture and dust. Fragile components should be additionally protected with shock-absorbing materials.
The packaging must also contain clear labeling of the medical equipment with indication of possible fragility, as well as temperature and other handling requirements.
3 - securing, loading and unloading;
Loading and unloading of medical equipment must be carried out by qualified personnel to avoid damage.
During transportation, the equipment must be securely fastened inside the vehicle to prevent shifting or damage.
These requirements are intended to ensure that the medical equipment is safe and ready for use without risk to patients and medical personnel.
6. Labeling and labeling requirements
Labeling of medical equipment plays a key role in ensuring its proper use. In the Russian Federation, requirements for medical equipment labeling are regulated by a number of regulatory documents, including GOST 15223-1-2020.
Taking into account the requirements for labeling and labeling in the production and launching into circulation of medical equipment, it is mandatory to specify:
1 - information about the manufacturer (importer):
- Name of the manufacturer;
- Manufacturer's address;
- Contact information for communication;
- If the medical equipment is imported, all the above-mentioned information about the importer shall be provided;
2 - data identifying the medical equipment:
- Trade name;
- Model;
- Serial number or batch number;
- Date of manufacture;
- Shelf life (service life);
3 - instructions for use:
- Main purpose of the medical equipment;
- Brief instructions for its use;
- Warnings and precautions;
4 - symbols and pictograms:
Symbols and pictograms shall be indicated taking into account foreign ISO requirements in order to convey information without language barriers;
5 - conformity marking:
- The presence of a conformity mark (e.g. EAC) shall be indicated to confirm the compliance of medical devices with technical regulations.
6 - storage and transportation conditions:
- Specific conditions of storage and transportation of medical equipment shall be indicated on the packaging and only if necessary.
All information on the packaging must be presented in Russian. If necessary, some instructions may be in Latin.
Additional information may also be indicated on the packaging of medical equipment:
7 - unique product identification (UDI):
- The introduction of the system of unique identification of medical equipment (UDI) allows tracking the movement of goods from the manufacturer to the end consumer and preventing counterfeiting. The UDI code is applied in Data Matrix format and contains information about the manufacturer, date of manufacture and other data.
8 - Sterility labeling:
- If the medical device is sterile, this shall be indicated with the use of the appropriate symbol.
9 - Single use indication:
- For single use medical devices, an appropriate symbol or inscription is required.
7. Liability in case of violations
For violations in the field of turnover of medical equipment, which is a subtype of medical devices, various types of responsibility are provided, including administrative and criminal.
The Code of Administrative Offenses of the Russian Federation stipulates responsibility for violation of the established rules in the sphere of circulation of medical devices (Article 6.28 of the CAO RF).
The sanction of Article 6.28 of the CAO RF provides for imposition of an administrative fine on citizens in the amount from 2,000 to 4,000 rubles; on officials - from 5,000 to 10,000 rubles; on legal entities - from 30,000 to 50,000 rubles.
Administrative responsibility under article 6.33 of the CAO RF is provided for production, sale or import into the territory of the Russian Federation of falsified, counterfeit, substandard and unregistered medical devices.
Administrative responsibility under article 6.33 of the CAO RF is provided for in the following forms: imposition of an administrative fine on citizens in the amount from 70,000 to 100,000 rubles; on officials - from 100,000 to 600,000 rubles; on individual entrepreneurs - from 100,000 to 600,000 rubles or administrative suspension of activity for a period of up to 90 days; on legal entities - from 1 million rubles to 5 million rubles or administrative suspension of activity for a period of up to 90 days.
The Criminal Code of the Russian Federation provides for liability for the illegal production of medical devices (Article 235.1 of the Criminal Code of the Russian Federation), as well as for the production, sale or importation into the territory of the Russian Federation of falsified or unregistered medical devices (Article 238.1 of the Criminal Code of the Russian Federation).
Article 235.1 of the Criminal Code provides for criminal liability up to imprisonment for a term of 5 to 8 years with a fine of 1 million rubles to 3 million rubles or in the amount of wages or other income of the convicted person for a period of 1 to 3 years or without it.
Article 238.1 of the Criminal Code of the Russian Federation provides for criminal liability up to imprisonment for a term of 8 to 12 years with a fine of 2 million rubles to 5 million rubles or in the amount of wages or other income of the convicted person for a period of 2 to 5 years or without it and with or without deprivation of the right to hold certain positions or engage in certain activities for up to 10 years.
The sanctions are quite strict, as they include such qualifying features as commission by a group of persons by prior conspiracy or by an organized group, as well as consequences in the form of death by negligence or serious harm to health. The sanctions are also serious enough due to the fact that they are aimed at preventing violations in the sphere of medical equipment production and ensuring the safety of an unlimited number of patients and medical workers.
8. Conclusions
The production of medical equipment very closely overlaps with the sphere of production of medical devices, as equipment is one of the types of products within the meaning of the current legislation.
The requirements of the current legislation cover all stages of production and launch into circulation of medical equipment, starting with the state registration of medical equipment and up to the manufacturer's post-marketing control over its products.
Violations in the production and sale of medical equipment entail serious administrative and criminal liability. This emphasizes the importance of compliance with legislation, including equipment registration and continuous quality control of production. The production of medical equipment requires technical precision, a high level of organizational responsibility and a competent legal approach to documenting all stages of production.
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