Information for registry certificate holders

Information letter for domestic manufacturers of medical devices and medical equipment Republican state enterprise on the right of economic management "National Center for Expertise of Medicinal Products and Medical Devices" of the Medical and Pharmaceutical Control Committee of the Ministry of Health of the Republic of Kazakhstan informs all holders of registration certificates, manufacturers of medicinal products, medical devices and medical equipment on the need to provide the following information:

- Holders of drug registration certificates (in accordance with Annex 2, Annex 3):

1.   Master file of registration certificate holder pharmacovigilance system (latest version);

2.   Contact information form (Annex 6);

- Manufacturers, representatives of manufacturers of medical devices and medical equipment (according to Appendix 4, Appendix 5):

1.     Document describing the system for monitoring the safety of medical devices and medical equipment;

2.     Quality guidelines;

3.     Contact information form (Annex 7).

The deadline for submitting the requested documents is 30 calendar days from the date the information publishes on the website www.ndda.kz.