shanghai SEC Company provides services for the entire cycle of Registration / Re-registration of Medical Devices, Medical Equipment starting from collecting the Registration Dossier in accordance with the requirements of the Republic of Kazakhstan up to obtaining Registration Certificate.
Kazakhstan registration of medical devices,medical equipment
shanghai SEC Company provides services for the entire cycle of Registration / Re-registration of Medical Devices, Medical Equipment starting from collecting the Registration Dossier in accordance with the requirements of the Republic of Kazakhstan up to obtaining Registration Certificate.
Medical Product Registration Procedure in the RK is carried out according to Order of the MoH of the RK № 735 "On approval of Rules of State Registration, Re-registration and Amendments to Registration Dossier of Drugs, Medical Devices and Medical Equipment" dated November 18, 2009
The term of preparation of Registration Dossier for submission depends on quality of the source documents and conditions negotiated with Client.
We'll be glad to answer all your questions by the following contacts:
Application documents
1 Power of attorney
2 Business registration of manufacturer in country of origin
3 ISO 9001 and
ISO 13485
4 Certificate MDD 93/42 / ЕЕС (CE certificate)
5 Declaration of conformity (if risk class of device is 1 or 2a)
(or Certificate MDD 98/79 / ЕЕС for In-Vitro products)
6 Technical file (that was used for CE certification)
7 User manual (with all accessorizes and reference numbers description)
8 Brochure (with all accessorizes and reference numbers) with color photo of product (a4 size)
9 FDA registration certificate
10 Free sale certificate
11 License for the medical device manufacturing
12 Product registration in China (or Taiwan)
13 Registration certificate (medical device registration) in country of origin
14 Technical documentation (technical file or normative document) in country of origin.
SCHEME OF OUR COOPERATION
1 Signing a confidentiality agreement
2 Examination of the submitted documents, giving to the applicant the status of documents, request the missing documents; calculation of the number of samples and standards for analytical examination, calculation of the cost of our services, inclusive of all the additional work to prepare the registration dossier (IDA development, translations, etc.); calculation of the overall preparation of the dossier and aggregate term of registration.
3 Conclusion of a contract for services
4 Formation of the registration dossier. Development of analytical-normative document (IDA), the drafring of instructions for medical use, the development of labeling in Russian and Kazakh languages.
5 Execution of the contract between the Applicant and the National Center for medicines, medical devices and medical equipment Expertise of Ministry of Health of the Republic of Kazakhstan.
6 Obtaining of permits to import samples of the pharmaceutical products and the organization of import procedures and customs clearance.
7 Filing of documents for the registration dossier, samples and standards to the National Center for medicines, medical devices and medical equipment Expertise of Ministry of Health of the Republic of Kazakhstan.
8 Receipt of invoice for payment of examination in the National Center for medicines, medical devices and medical equipment Expertise of Ministry of Health of the Republic of Kazakhstan.
9 Maintenance and monitoring at all stages of registration, compliance with comments;
10 Agreed with the customer IDA projects, instructions for medical use, layout packages
11 Obtaining the original registration certificates and normative documents and send them to the Customer;
The term of the initial examination of the documents submitted - 1-3 days.
The term of preparation of documentation for submission to the Government authorities 7- 15 working days.
上海经合工业设备检查有限公司
021-36411223 021-36411293
邮件：gost@gost.org.cn gost-r@163.com
skype:gostchina
微信：18621862553
www.gost.org.cn
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