MINISTRY OF HEALTH
PHARMACY AND POISONS BOARD
(Section 3B(2)(e) of the Pharmacy and Poisons Act, Cap 244 Laws of Kenya)
MEDICAL DEVICE REGISTRATION CERTIFICATE
This Registration Certificate is issued to
CROWN HEALTHCARE
for distribution and sale of
SWS Hemodialysis Equipment
Registration Number: MD/2023/1395
Certificate Valid Until: 21st September 2028
Registration Date: 22nd September 2023
Device Category: Class C
GMDN:
GMDN Term: Class C
Intended Purpose:
The Hemodialysis
Equipment device is designed for performing chronic and acute hemodialysis.
MAH Details:
SWS HEMODIALYSIS CARE CO., LTD.
Manufacturing Sites :
SWS HEMODIALYSIS CARE CO., ,
Device Accessories:
, Puncture
needle, Dialyzer, Dialysis concentrate, Citric acid disinfectant, Extracorporeal blood circulation
line, Endotoxin retentive filter, Substitution fluid line, , ,, , , , ,,,,
,,,,
Device Group:
Device Sub-group/Sub-sets:
SWS-4000A, SWS-4000, SWS-6000A, SWS-6000.
Condi ns
The above Medical Device has been entered on the Record subject to the following cond ons:
The granted approvals herein are in accordance to the Laws of Kenya, Health Amendment Law 2019 and
the applicant is required to adhere to the s pulated cond ons.
Each applicant/MAH/Product Owner shall retain records of the distribu on of all of the applicant's
medical devices included in the records for Medical Devices. In the case of records rela ng to a
Class ve Implantable Medical Device (AIMD) medical device, Class C medical device, or Class B
medical device that is an implantable medical device, the distribu on records shall be retained for a
minimum period of 10 years. In the case of records rela ng to any other device, the distribu on records
shall be retained for a minimum period of 5 years.
The applicant of a medical device shall keep an up to date log of informa on of all the medical
devices registered.
It is a cond on of inclusion in the PPB that the applicant of a medical device that is an AIMD, Class for
implantable Class B provides three consecu ve annual reports to the Medical Devices Department ,
Directorate of Product Evalua on following registra on of the Medical Device. Reports should be for the
period 1 July to 30 June. The first report following the date of inclusion in the PPB records must be for a
period of at least six months but no longer than 18 months. The annual report must include all
complaints and adverse events received by the manufacturer rela ng to problems with the use of the
device that have been received by them over the year.
A applicant shall ensure that a medical device within their control is stored and transported in
accordance with the instru ons and informa on provided by the manufacturer.
Products Covered by This Entry
Product Specific Condi ns
Pharmacy and Poisons Board
Head Office, Lenana Road
Po Box 27663-00506
Nairobi, Kenya
Serial NO: 74359135bdf3e0bd869804a9f27025cb
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Date: 22-09-2023
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