An opinion on the completeness and correctness of the documents submitted: 1 assessment of the completeness of the documents and materials submitted; 2 assessment of the layout of the application and the materials submitted; цвет лазера co2 для волос assessment of the submission of information under paragraph 8 hereof; 4 consistency between the application kazakhstan medical device regulations the paper-based and electronic materials. Производители медицинских изделий класса потенциального риска применения 3 до представления документов на экспертизу и регистрацию медицинских изделий внедряют систему менеджмента качества медицинских изделий в kazakhstan medical device regulations со стандартом ISO, включая диодный лазер эпиляция как часто делать проектирования и разработки. Palomar vectus лазер москва анализа лекарственного средства, представленного заявителем и или найденного самостоятельно лазер magic one диодный по анализу заявки:. If the dossier includes confidential information, it shall be indicated which information is confidential and justification shall be provided for the confidential nature of the information. List of required documents manufacturing of medical devices 4.
- Удаление диодным лазером новообразований аппарат
- Миостимулятор для мышц тазового дна отзывы
- Узи исследования на аппарате экспертного класса отзывы
- Диодный лазер фотоэпиляция
MEASURES TO PREVENT THE PURCHASE OF LOW-QUALITY MEDICAL EQUIPMENT
How is the document calculated? Why do medical devices undergo testing? Is it possible to suspend or revoke the registration certificate of a medicine? What is the period of registration of a medicine? When is it not possible to conduct clinical or preclinical trials? List of documents required for registration. Which documents are required to obtain an import license for medical equipment in Kazakhstan? Which documents are required to obtain a license for medical and pharmaceutical activity in Kazakhstan? Which documents are required for registration? Which documents must be submitted to obtain a certificate of approval of the type of measuring instruments in Kazakhstan? Which documents must be submitted to obtain a certificate of conformity for products in Kazakhstan?
Which documents on the status of pharmacovigilance activities are required to be submitted? Are illustrations, images and graphics included in the calculation of a document? Graphic illustrations are not included in the calculation if there is no text on them that needs translation. Services Metrological qualification in Kazakhstan Order service. Service cost. State license fee. FAQ 1. Documents are calculated in characters. One page equals characters with spaces. To confirm that the product meets the declared technical characteristics, does not pose a danger to human health, and has clinical effectiveness.
Yes, registration is canceled if the registration certificate expires or if this medicine has not been in circulation for more than 3 consecutive years. Kazakhstan Drug Registration Process 2. By law, the registration period is determined as follows: If you have a complete package of documents, calendar days, not including the preclinical period, the period of clinical trials, the time to eliminate remarks, and inspection of the manufacturing site.
When the drug is registered and in circulation for more than 20 years. In all other cases, clinical trials are a mandatory part of the procedure. ZRK About permissions and notifications 5. ZRK About ratification of the Agreement on licensing rules in the field of foreign trade in goods 6. SAM on export control 7. Licenses for the import of certain types of goods 8. License to import products subject to export control 9. Decree No. ZRK About permissions and notifications 3. List of required documents manufacturing of medical devices 4. List of required documents wholesale and retail sales of drugs 5. The list of necessary documents production of medical devices and MT 6.
List of required documents 7. Order No. Sanitary and epidemiological requirements for healthcare facilities. List of documents required for registration 1. Kazakhstan List of DS documents. If products are imported from abroad, all documents in a foreign language must be translated into Russian. The translations must be certified in the prescribed manner. Customs Union Technical Regulations Register entry 4.
SAM on ensuring the uniformity of measurements 5. List of documents OBK declaration 2. List of OBK documents for serial production 3. List of OBK documents of each series batch of products 4. Cost and terms. Заказать звонок Перезвоним в течение дня. Нажимая кнопку «Отправить», я даю свое согласие на обработку моих персональных данных, в соответствии с Федеральным законом от Согласие на обработку персональных данных. Согласие дается на обработку одной, нескольких или всех категорий персональных данных, не являющихся специальными или биометрическими, предоставляемых мною, которые могут включать: - Имя; - Телефон; - E-mail; - Комментарий. Оператор может совершать следующие действия: сбор; запись; систематизация; накопление; хранение; уточнение обновление, изменение ; извлечение; использование; блокирование; удаление; уничтожение.
Способы обработки: как с использованием средств автоматизации, так и без их использования. Москва, б-р Энтузиастов, д. Настоящее согласие действует до момента его отзыва путем направления соответствующего уведомления на электронный адрес mamedov. Не принимаю. Прочитайте до конца.
Metrological qualification in Kazakhstan
The conformity assessment of medical devices and medicines is a mandatory procedure of state supervision. By conducting this procedure the fulfillment of safety and quality requirements shall be assessed. Following the conformity assessment, a certificate in form of a state registration of medical devices and drugs as well as an EAC declaration is issued in order to confirm that the medical and medicinal products are in compliance with the minimum requirements of the technical regulation in Russia, Kazakhstan and the EAEU. The purpose of the conformity assessment is to guarantee the safety of the products. In the EAEU the requirements for medical devices have been harmonized.
Metrological qualification in Kazakhstan
To approve the attached Rules for conducting inspections of medical devices. The Committee for Medical and Pharmaceutical Control of the Ministry of Health of the Republic of Kazakhstan, in accordance with the procedure established by the legislation of the Republic of Kazakhstan, shall ensure:. Control over the execution of this Order shall be entrusted to the supervising Vice-Minister of Healthcare of the Republic of Kazakhstan. This Order shall come into effect upon the expiration of ten calendar days after the day of its first official publication. Minister of Healthcare of the Republic of Kazakhstan A.
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