MEDICINES CONTROL COUNCIL

Transcription

1 MEDICINES CONTROL COUNCIL GUIDELINE FOR MEDICAL DEVICE QUALITY MANUAL This guideline is intended t prvide recmmendatins t applicants wishing t submit applicatins fr a licence t manufacture, imprt, distribute and exprt a medical device, including In Vitr diagnstics medical devices (IVDs). It represents the Medicines Cntrl Cuncil s current thinking n the safety, quality and perfrmance f medical devices and IVDs. It is nt intended as an exclusive apprach. Cuncil reserves the right t request any additinal infrmatin t establish the safety, quality and perfrmance f a medical device r IVD in keeping with the knwledge current at the time f evaluatin. Alternative appraches may be used but these shuld be scientifically and technically justified. The Cuncil is cmmitted t ensure that all registered medical devices and IVDs will meet the requirements f the Essential Principles relating t quality, safety and perfrmance. It is imprtant that applicants adhere t the administrative requirements t avid delays in the prcessing and evaluatin f applicatins. Guidelines and applicatin frms are available frm the ffice f the Registrar f Medicines and the website. First publicatin fr cmment March 2017 Clsing date fr cmment 28 April 2017 DR JC GOUWS REGISTRAR OF MEDICINES 8.07_Medical_Device_Quality_Manual_Feb17_v1_fr_cmment March 2017 Page 1 f 6

2 TABLE OF CONTENTS Page 1 INTRODUCTION SCOPE OF GUIDELINE QUALITY MANUAL Cmpany Details Quality Management System Site Infrmatin... 4 Table 1 Summary f infrmatin in REFERENCE UPDATE HISTORY _Medical_Device_Quality_Manual_Feb17_v1_fr_cmment March 2017 Page 2 f 6

3 1 INTRODUCTION A persn wh makes applicatin fr a licence t imprt, manufacture, distribute r whlesale a medical device in Suth Africa must implement and maintain a dcumented quality management system which is relevant t ne r mre stages f the life-cycle f the medical device, as required by clause 5 f the Regulatins fr Medical Devices and IVDs. 2 SCOPE OF GUIDELINE The scpe f this guideline is t identify the minimum requirements f the which a persn wh makes applicatin fr and hlds a licence t imprt, manufacture, distribute, exprt r whlesale a medical device, including an in vitr diagnstic (IVD) medical device, must prepare and maintain up t date at all times. 3 QUALITY MANUAL The must prvide an verview f the dcumented quality management system which is in peratin and must include infrmatin abut the rganisatin, the facility/ies, the key persnnel, the quality assurance plicy/ies, prcedures, wrk instructins, cntrls and activities which are undertaken by the rganisatin t demnstrate its ability t prvide medical devices and related services that cnsistently meet the Suth African regulatry requirements. A summary f the key infrmatin in the, as aligned t the ISO13485 framewrk, is nted in Table 1 belw. The fllwing infrmatin must be included in the : 3.1 Cmpany Details Cmpany registered name and cmpany registratin number r in the case f a natural persn the persn s full name and Identity Number. Registered physical address. Registered pstal address. MCC Licence details, including type f licence, licence number and perid f validity. The number and type f facilities in Suth Africa. 3.2 Quality Management System The scpe and span f the Quality Management System (QMS) i.e. is the QMS fr ne r multiple sites. Details f the standard t which the QMS is implemented and the status f the certificatin theref, e.g. certificatin t ISO13485:2016 and perid f validity. An verview f the frmal prcedures within the QMS and a descriptin f the interactin between the prcedures, including vigilance, reprting adverse events t the MCC, recall and change cntrls. The type and risk class f medical device prducts imprted, manufactured, distributed, exprted r serviced Whether the medical devices are currently distributed fr human administratin r veterinarian administratin. 8.07_Medical_Device_Quality_Manual_Feb17_v1_fr_cmment March 2017 Page 3 f 6 Back t TC

4 Details f the rganisatin f persnnel, rles and respnsibilities (rganisatin chart) Details f the external / third party service prviders, e.g. scientific analytical r ther technical assistance in relatin t imprtatin / manufacture / warehusing / deliveries / distributin /exprt / cmpliance etc. which the Cmpany uses. Details must include the full name, physical address and cntact details f each service prvider with the type f service identified. 3.3 Site Infrmatin The fllwing cmpany infrmatin is t be cmpleted fr each site where any manufacturing and strage activity, such as, but nt limited t - manufacture, packing, labelling, strage, reprcessing (cleaning) and service takes place: Physical address; Pstal Address; Telephne: Office hurs; Key Cntact Persns & cntact details ( and telephne) fr each: Authrised Representative: (24 hur telephne number) Managing Directr Operatins/Prduct Manager; Quality Assurance Manager; Regulatry Affairs Manager (where relevant) Details f the access cntrls and security cntrl measures in place; Details f the structure f the building where prduct is manufactured, packed, serviced and stred, including type f flrs, type f walls, type f ceilings, etc.; Apprximate size f the spaces (m2) in which manufacturing, packing, labelling, strage, reprcessing and service takes place; Details f the ventilatin / air cntrls and envirnmental cntrls; Details f equipment, such as the fllwing equipment (list as relevant): Water treatment plant Air handling unit Sluice fr waste water Special structural and r safety features / characteristics f the facility, manufacturing and strage areas Street map where the facility lcated. Site and facility plan Details f the number f emplyees engaged in the key departments 8.07_Medical_Device_Quality_Manual_Feb17_v1_fr_cmment March 2017 Page 4 f 6 Back t TC

5 Table 1 Summary f infrmatin in SUBJECT ISO REFERENCES 1 Cver page, table f cntents and authrizatin statement ========== 2 Cmpany prfile (refer belw) ========== 3 Cntrl and distributin ========== Quality Management System General requirements 4.1 Dcumentatin requirements 4.2 Management Respnsibility 5.0 Management cmmitment 5.1 Custmer fcus Quality Plicy 5.3 Planning 5.4 Respnsibility, authrity and cmmunicatin 5.5 Management review 5.6 Resurce Management 6.0 Prvisin f resurces Human resurces 6.2 Infrastructure 6.3 Wrk envirnment and cntaminatin cntrl 6.4 Prduct Realizatin 7.0 Planning f prduct realizatin 7.1 Custmer Related Prcesses Design and develpment 7.3 Purchasing 7.4 Prductin and service prvisin 7.5 Cntrl f mnitring and measuring equipment 7.6 Measurement, Analysis And Imprvement 8.0 General Mnitring and measurement 8.2 Cntrl f Nncnfrming Prduct 8.3 Analysis f data 8.4 Imprvement _Medical_Device_Quality_Manual_Feb17_v1_fr_cmment March 2017 Page 5 f 6 Back t TC

6 SUBJECT ISO REFERENCES 9 List f prcedures ========== 10 Glssary f terms ========== 11 Prcess flw chart ========== 12 Quality Plicy ========== 13 Organizatin structure ========== 4 REFERENCE ISO 13485:2016 Medical devices - Quality management systems Requirements fr regulatry purpses 5 UPDATE HISTORY Date Reasn fr update Versin & Publicatin February 2017 First publicatin fr cmment Versin 1, March April 2017 Due date fr cmment 8.07_Medical_Device_Quality_Manual_Feb17_v1_fr_cmment March 2017 Page 6 f 6 Back t TC