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Medical devices operating

Services

Dietary Supplement Registration

Assistance in obtaining permits for dietary supplements

Medical Device Registration

Support in medical device registration

Medicinal Product Registration

Pharmaceutical product registration

Pharmacovigilance

Reliable pharmacovigilance

Quality and safety assessment

Quality and safety assurance

Documentation Translation

Professional medical document translation

Reference Pricing

Pricing expertise

About Us

Star TAD Logotype

Star TAD is your reliable partner in the field of registration and certification of medical products. We specialize in preparing all required documentation for dietary supplements, medical devices, and medicinal products. With many years of experience in this area, our team of experts provides full support throughout the registration process, from documentation preparation to obtaining certificates. We also offer pharmacovigilance services, quality and safety assessment, professional translation of medical documentation, and consultations on reference pricing. Star TAD guarantees an individual approach to each client, aiming to ensure maximum efficiency and safety of your products. Your trust is our core value.

About Star TAD

Ready to start a project with us?

Our team of experts is ready to answer your questions and help you find the best solution for your project. Contact us today.

Why to choose us

Fast turnaround

With optimized processes, we ensure fast preparation and registration of your products.

Professional team

Our team consists of experienced specialists ready to deliver effective solutions for your needs.

Quality assurance

We maintain a high standard of service by following international standards and regulations.

More about services

Dietary Supplement Registration

Dietary Supplement Registration

Comprehensive support in the registration process of dietary supplements, including preparation of required documentation, conducting necessary studies, and interaction with regulatory authorities.

List of services:
  • Review of client-provided documents and identification of potential risks.
  • Translation and notarization of documentation.
  • Assistance with customs clearance and import of samples for testing.
  • Support during laboratory testing.
Medical Device Registration

Medical Device Registration

A full range of services for medical device registration, including documentation preparation, certification, and obtaining permits to market the product.

List of services:
  • Client consultations
  • Amendments to registration certificates and dossiers
  • Preparation of registration dossiers
  • Development and analysis of technical documentation
  • Interaction with testing laboratories and support during testing
  • Interaction with regulatory authorities
Medicinal Product Registration

Medicinal Product Registration

Assistance in preparing all required documents for the registration of medicinal products, including clinical trials and preparation of the registration dossier.

State registration under the national procedure.
  • Client consultations
  • Preparation of the registration dossier
  • Interaction with testing laboratories and regulatory authorities
  • Support during the assessment of manufacturing conditions (Manufacturing inspection)
  • Assistance in obtaining an official letter from the state authority confirming that the product is subject to state registration as a medical device
Pharmacovigilance

Pharmacovigilance

Monitoring the safety of medicinal products at all stages of the life cycle, ensuring compliance with pharmacovigilance requirements and responding to adverse reactions.

Pharmacovigilance services are provided in accordance with the legislation of the Republic of Kazakhstan and the EAEU and include:
  • Continuous monitoring and assessment of data regardless of its source (from patients, healthcare professionals, pharmacists, published literature, and the website of the Authorized Authority of the Republic of Kazakhstan).
  • Submission of CIOMS reports to the Authorized Authority of the Republic of Kazakhstan within the timelines established by legislation.
  • Notification of the Authorized Authority of the Republic of Kazakhstan about changes in the safety profile, new risks, the pharmacovigilance system master file, risk management system, and periodic safety update reports.
  • Investigation of adverse reactions.
  • Client information support (updates on new laws and regulations).
  • Ensuring effective interaction with the Authorized Authority of the Republic of Kazakhstan and appointment of a responsible pharmacovigilance officer within the territory of the Republic of Kazakhstan.
Quality and safety assessment

Quality and safety assessment

Comprehensive assessment of the quality, efficacy, and safety of medical devices and medicinal products to confirm compliance with international standards.

List of services:
  • Obtaining a certificate of conformity through declaration for medicinal products and medical devices.
  • Sampling products from the market.
  • Obtaining import permits for medicinal products and medical devices into Kazakhstan.
  • Collecting and analyzing the required documentation.
  • Developing local documentation when necessary.
  • Developing local documentation when necessary.
Documentation Translation

Documentation Translation

High-quality translation of medical, pharmaceutical, and regulatory documentation, ensuring full compliance with the original content.

Reference Pricing

Reference Pricing

Analysis and establishment of reference prices for medicinal products and medical devices, including strategic pricing planning and pricing consultations.

  • price registration or re-registration
  • for medicinal products subject to wholesale and retail distribution
  • for medicinal products intended for provision within the Guaranteed Volume of Free Medical Care and/or the Mandatory Social Health Insurance system: analysis of maximum prices for medical equipment

Services in the direction of Reference Pricing

Pricing expertise. We provide a full range of services, including:

Client consultations
Preparation of the registration dossier
Interaction with testing laboratories and regulatory authorities
Support during the assessment of manufacturing conditions (Manufacturing inspection)
Assistance in obtaining an official letter from the state authority confirming that the product is subject to state registration as a medical device

Registration of medical devices under the EAEU rules grants the right to market and use products within the member states of the Eurasian Economic Union. The authorization is issued by the competent authority of the reference state. It must also be obtained when medical devices are imported from third countries.

Re-registration of medical products and medical equipment is carried out when the registration certificate expires. An application for re-registration must be submitted before the registration certificate expires. Upon completion of the re-registration procedure for medical products and medical equipment manufactured in accordance with ISO 13485 requirements, a perpetual registration certificate is issued.

During the validity of the registration certificate, an amendment procedure may be carried out when necessary. List of changes to the medical device registration dossier that do not require a new registration:
  • change of information about the manufacturer/manufacturing site of the medical product/medical equipment;
  • change of information about the authorized representative, including reorganization of the legal entity, change of its name, and change of surname, name, patronymic (if any), and address of residence of an individual entrepreneur;
  • change of the name of the medical product and/or medical equipment;
  • change in the composition of accessories and/or components and/or consumables, software update (installation of a new version);
  • change in indications for use; scope of use; contraindications; adverse effects;
  • change of manufacturers of components, accessories, consumables;
  • increase/decrease of the shelf life of the medical product;
  • change of storage conditions;
  • change in the finished product quality control procedure for the medical product;
  • change of packaging of the medical product: primary packaging, secondary and/or group packaging, transport packaging, intermediate packaging;
  • change of imprints, primers, or other markings, stamps, and inscriptions, including adding or changing the ink used for marking the medical product.

Other changes require a new registration procedure.

A manufacturing inspection is required if the registration submission includes a manufacturing site responsible for release that has not previously been registered in Kazakhstan. The inspection procedure is approved by Order No. 742 of the Ministry of Health and Social Development of the Republic of Kazakhstan dated November 19, 2009, "On Approval of the Rules for Conducting Inspections in the Field of Circulation of Medicines, Medical Products, and Medical Equipment".
The procedure defines the following reasons for conducting an inspection:
  • obtaining a certificate (conclusion) or extending its validity, including in accordance with Good Pharmacovigilance Practice (GVP);
  • for licensing pharmaceutical activities, registration, examination of medicines, or investigations related to the safety, quality, and efficacy of medicines and medical devices, according to the pharmaceutical inspection program;
  • based on the results of a previous pharmaceutical inspection to confirm correction of identified non-conformities;
  • to confirm, for entities holding a certificate of compliance with Good Pharmaceutical Practices in the field of circulation of medicines, at least once every two years according to an inspection schedule approved by the head of the state authority or its territorial subdivision.

The inspection is conducted to confirm compliance with national GMP requirements for sites performing batch release. The inspection is carried out by a group of state experts. The applicant pays the cost of the inspection work, as well as transportation and accommodation expenses.
Oversight of ongoing GMP compliance is conducted every two years.
Expert Answering Questions

Frequently asked questions

To get started, please contact us by phone +7 702 325 1996 or send a request to our email info@startad.kz. We will be happy to discuss your needs and how we can help.

The time required for the registration process may vary depending on the product type and project specifications. For accurate information, please contact us via info@startad.kz or by phone +7 702 325 1996.

To register a medical device, you will need to provide a certificate of conformity, clinical study data, a technical description, as well as documentation confirming the safety and effectiveness of the device. To learn about the list of required documents, please contact our specialist by phone +7 702 325 1996 or via email info@startad.kz.

The cost of pharmacovigilance services depends on the scope and complexity of the project. We offer an individual approach to each client. Please contact us at info@startad.kz or call +7 702 325 1996.

Our company specializes in the registration of medical products in Russia, CIS countries, as well as the European Union and the United States. For a detailed consultation on the regions you are interested in, please contact our experts via info@startad.kz or call our hotline at +7 702 325 1996.

We are proud of many successfully completed projects. One recent example is the registration of an innovative medical device for the diagnosis of heart diseases. Detailed information about the project and the registration process can be found on our website in the "Cases" section or requested via email info@startad.kz.

We place great importance on confidentiality and data protection. All projects are carried out in compliance with strict security and confidentiality measures, supported by relevant documents and agreements. You can learn more about our principles by contacting us at info@startad.kz.

Get a personalized consultation right now!

We believe every project is unique. Let our experts create a tailored solution that meets your needs. Fill out the form, and we will contact you shortly.

Reviews

Our cases

Кейс 1

Registration of an innovative dietary supplement

Task:

The dietary supplement manufacturer needed to obtain a registration certificate for a new product based on natural ingredients.

Solution:

Star TAD conducted a comprehensive analysis of the product composition, organized the required laboratory studies, and prepared and coordinated the full set of documents for registration.

Result:

Thanks to effective coordination at all stages, the dietary supplement was successfully registered in a short timeframe, allowing the client to start sales in a new market.

Кейс 2

Certification of a medical device

Task:

The goal was to obtain CE marking for a medical device, enabling sales in European Union countries.

Solution:

Star TAD specialists prepared a complete set of technical documentation in accordance with EU requirements, organized product testing in accredited laboratories, and coordinated with the notified body to verify compliance.

Result:

The device successfully passed certification, granting the company access to the broad European market.

Contacts

Our address

Republic of Kazakhstan, 050000, Almaty, Bolashak microdistrict, Bolashak 25

Phone number

+7 702 325 1996

Whatsapp

+7 702 325 1996

Email

info@startad.kz