Medical Device Licensing Wkshop Medicines Control Council Dr Joey Gouws 26 July 2016 Civitas, Pretia
Welcome 2
3 Agenda Legal context Key principles & intent Types of Licence Licence Fees Guidelines Licence Application
Legal Framewk: Medicines and Related Substances Act, 1965 (Act 101 of 1965 as amended) Preamble includes. to provide f the control of medicines and scheduled substances and medical devices;.to provide f the licensing of certain persons to compound, dispense manufacture medicines and medical devices and also to act as wholesalers distributs; 4
5 Medicines and Related Substances Act, 1965 (Act 101 of 1965 as amended) Section 22C Licensing 22C(1)(b) the Council may, on application in the prescribed manner and on payment of the prescribed fee, issue to a manufacturer, wholesaler distribut of a medicine medical device a licence to manufacture, impt expt, act as a wholesaler of distribute, as the case may be, such medicine medical device, upon such conditions as to the application of such acceptable quality assurance principles and good manufacturing and distribution practices as the council may determine.
Medicines and Related Substances Act, 1965 (Act 101 of 1965 as amended) Medical device means any instrument, appliance, material, machine, apparatus, implant diagnostic reagenta) used purpting to be suitable f use manufactured sold f use in i. the diagnosis, treatment, mitigation, modification, moniting prevention of disease, abnmal physical mental states the symptoms thereof; ii. iii. resting, crecting modifying any somatic psychic ganic function; the diagnosis prevention of pregnancy, and which does not achieve its purpose through chemical, pharmacological, immunological metabolic means in on the human body but which may be assisted in its function by such means; b) declared by the Minister by notice in the Gazette to be a medical device, and includes any part an accessy of a medical device; 6
Additional legal framewks regulating and impacting medical devices Hazardous Substances Act electro medical and radiation devices Standards Act, 2008 National Regulat f Compulsy Specifications Act [NRCS Act] Metrology Act SANAS: accredit inspection & certification bodies Foodstuffs, Cosmetics, Disinfectants Act 7
Regulat s Mandate Two distinct objectives: 1. Protect patients against harmful ineffective medicines and medical devices Gatekeeper function with obligation to apply stringent standards of assessment and to deny marketing authization where deemed necessary 2. Protect patients against the consequences of untreated disease Enabling medicine and medical device development to ensure that patients have access as early as possible to medicines and medical devices which are safe and perfm as expected 14
Key principles and Intent of Licensing Establish relevant quality assurance criteria f manufacture of medical devices in South Africa Identify requirements f imptation of medium to high risk and high risk medical devices Establish relevant distribution practices f distributs in South Africa Establish a list (data base) of all medical devices impted and manufactured in South Africa by risk classification, by manufacturer by distribut. Details of Manufacturers, Distributs & respective Authised Representatives 9
10 Types of Licences & associated activities 1. Licence to manufacture medical device IVD Impt Manufacture & distribute Expt 2. Licence to distribute medical device of IVD Impt Distribute Expt
11 Types of Licences & fees Type of Licence Manufacture Distribute New Licence application fee Licence retention fee per annum Licence renewal fee R21 000 R13 000 R3 000 R3 000 R19 000 R10 900
12 Guidelines 1. Medical Device Licensing Guideline: Manufacture / Distribut licence 2. Classification of Medical Devices and IVDs Guideline How to classify 3. Essential Principles of Safety and Perfmance f Medical Devices & IVDs
Guideline Classification of Medical Devices & IVDs Classes of medical devices and IVDs Class A Low Risk Class B Low-moderate Risk Class C Moderate-high Risk Class D High Risk where risk relates to the patient, user to public health. The Council shall consider the classification of a medical device IVD individually taking into account its design and intended use. If Classification of a medical device IVD is inconclusive and places it in me than one class between classes after following the technical rules the Council will place it in the higher of the risk classes. 13
14 Guideline Essential Principles of Safety & Perfmance of Medical Devices & IVDs General Principles 1.1 Use of medical devices not to compromise health and safety 1.2 Design and construction of medical devices to confm to safety principles 1.3 Medical devices to be suitable f intended purpose 1.4 Long-term safety 1.5 Medical devices not to be adversely affected by transpt stage 1.6 Benefits of medical devices to outweigh any side effects
Guideline Essential Principles of Safety & Perfmance of Medical Devices & IVDs cont. Principles about design and construction 2.1 Chemical, physical and biological properties 2.2 Infection and microbial contamination 2.3 Construction and environmental properties 2.4 Medical devices with a measuring function 2.5 Protection against radiation 2.6 Medical devices connected to equipped with an energy source 2.7 Infmation to be provided with medical devices. 2.8 Clinical evidence 2.9 Principles applying to IVD medical devices only 15
Part 2: Application f 16 Licence to Manufacture Distribute Medical Devices IVDs Manufacturer Distribut?
Application f Licence to Manufacture Medical Devices IVDs "manufacture" means operations that include the design, purchasing of material, specification development, production, fabrication, assembly, processing, reprocessing, releasing, packaging, repackaging, labelling, and refurbishing of a medical device IVD, as the case may be, and includes putting a collection of medical devices IVDs, and possibly other products, together f a medical purpose in accdance with quality assurance and related controls; 16
Application f Licence to Manufacture Medical Devices IVDs "manufacturer" means - (a) a natural legal person with the responsibility f the design, manufacture, packaging and labelling of a medical device IVD befe it is placed on the market under the natural legal person's own name, in the name of a firm company, regardless of whether these operations are carried out by that person by himself on his her behalf by a third party; (b) any other person who assembles, packages, reprocesses, refurbishes labels one me ready-made products assigns to them their intended purpose as a medical device IVD, with a view to their being placed on the market under the natural legal person's own name, except a person who assembles adapts medical devices IVDs already on the market to their intended purpose f patients; 17
Application f Licence to Manufacture Medical Devices IVDs "refurbish in relation to a medical device IVD means the whole part of a medical device IVD is substantially rebuilt, re-equipped, rewked rested, whether not using parts from one me used medical devices of that same kind, so as to create a medical device IVD that is used f the purpose iginally intended by the iginal manufacturer of the iginal medical device IVD, and without prejudice to the generality of the fegoing, refurbishment of a medical device may involve any all of the following actions including, but not limited to, repair, rewk, update of software hardware and replacement of wn parts with parts approved f use by the iginal manufacturer, perfmed in a manner consistent with product specifications and service procedures defined by the iginal manufacturer f that type of equipment without significantly changing the finished equipment's perfmance, safety specifications intended use as defined in its iginal registration; 18
Application f Licence to Distribute Medical Devices IVDs distribut means a natural legal person who a) impts expts a medical device IVD, which is on the register f medical devices on the register f IVDs in its final fm, wrapping and packaging, with a view to the medical device IVD being placed on the market under the natural legal person s own name; and b) sells the medical device IVD to a healthcare professional, healthcare institution, wholesaler the user; 19
Introduction MEDICINES CONTROL COUNCIL 1 1.1 2 3 5 6 6.1 LICENCE APPLICATION TO MANUFACTURE, IMPORT, DISTRIBUTE OR EXPORT MEDICAL DEVICES An application fm f the purpose of obtaining a licence renewing a licence in terms of the provisions of the Medicines and Related Substance Act, 1965 Section 22C and 22D This fm should be completed f each manufacturer of a medical device who wishes to manufacture, impt expt a medical device who wishes to renew their existing manufacture licence to manufacture, impt expt a medical device. Incomplete fms may be returned to the applicant. Please only add infmation into the designated cells in the electronic spreadsheet. The electronic fmat must be submitted on a memy stick a compact disc and must be accompanied by a printed version. No alterations on the printed version will be accepted. Printed documents with white out will not be accepted and will be returned. All required copies of certificates should be certified. The prescribed application fee f a licence must accompany any of these licence applications. F amount, refer to the summary of fees and charges available from the office of the Registrar. Note: Cheques should be made payable to Medicines Control Council 4 The completed fm should be sent to: The Registrar of Medicines Medicines Control Council Private Bag x828 Pretia, 0001 The licence is the property of the Medicines Control Council and must be returned upon demand. The licence remains valid f the period of five years from the date of issue unless otherwise suspended revoked by the Medicines Control Council. Licensing guidelines are available at the Medicine Control Council s website: www.mccza.com After five years the Manufacturer licensed to manufacture, impt expt a medicall device needs to renew the licence. 21
Guidance Section 1.1 2.1 5.3 23 A Name of the proposed license holder Guidance notes & General infmation Full, legal name of licence applicant owner of the business who wishes to manufacture, impt, distribute expt medical devices (must be full, legally identifiable name e.g. ABC Pty Ltd, Newcp Ltd trading as XYZ, Gillian Linda Smith trading as MNR). Please insert the individual's full name if trading as an individual manufacturer Manufacturer's Business Name If a cpation company, the name of the registered cpation company under the Companies Act and the registration number allocated by the Registrar of Companies. Name if trading under other business name, is the business name, name under which you propose to trade f purposes of the Act. Site Master File Part of the repting aspects of an inspection can be addressed by receiving infmation on related company details, e.g. details of the company's facilities, personnel structure and operating procedures including warehousing and distribution activities, pri to inspection. It is expected that a Site Master File be prepared and submitted to the Inspectate that should be in line with the guidelines on the preparation of a Site Master File, which can be obtained from the office of the Registrar of Medicines the Medicines Control Council website at: www.mccza.com. Inspection Befe a licence may be issued renewed, the Inspectate may conduct an inspection of the company's distribution operations to assess confmity, f example to ISO13485:2016 one me Standards as determined by the Medicines Control Council. Declaration This declaration seeks assurances that the requirements of Section 22C and 22D of the Act, have been satisfied and that the infmation provided in the application is current and crect at the time it was signed by the distribut, impter expter. The declaration in A (iii) is intended to establish whether a distribut has relevant procedures in place to suppt a comprehensive quality management system to comply with current acceptable quality assurance principles and good housekeeping practices accding to a standard as determined by the Medicines Control Council. A penalty applies f false and misleading statements made in relation to this application. Persons signing the declaration should be the manufacturer, the manufacturer's duly appointed Authised Representative who is responsible to the Medicines Control Council f compliance with the Act Name Full name 23 A iv) Position The role in the ganization e.g. Owner, Authised Representative. Essential Principles of Safety and Perfmance 22 Pursuant to the Essential Principles of Safety and Perfmance f Medical Devices the Council may determine written principles to be observed by a manufacturer of a medical device. These principles will primarily comprise the Guidelines on the Essential Principles of Safety and Perfmance f Medical Devices and IVDs.
Guidance cont. Section # 1-3 4.1 4.2 4.3 4.4 5.1 to 15.3 Instructions f Completion The following documents must each be completed in full; and each page must be completed in electronic fmat (MS Excel) [If the details f sections are not relevant then mark "not relevant"; the file must be named using the naming fmat as follows: "20YYMMDD_Licence_Application_f_Med_Dev_Manufacture_COMPANYNAME.xls"; the electronic file must be submitted to MCC on a memy stick CD ROM, clearly marked with the Company name; the submission must include a printed copy of each page; each page of the printed copy must be initialled in black ink on the lower right cner of the page by the Authroised Representative; the declaration must be signed in full in black ink by the Authised Representative. General Infmation - Sections 1.1 to 3.1 [one page] NON-IVDs MANUFACTURED in SA - Section 4.1 IVDs MANUFACTURED in SA - Section 4.2 NON - IVDs IMPORTED into SA - Section 4.3 [Number of pages dependent on number of products]. IVDs IMPORTED into SA - Section 4.4 [Number of products dependent on number of products]. MANUFACTURING SITE A INFO - Sections A 5.1 to 15.3 MANUFACTURING SITE B INFO - Sections B 5.1 to 15.3 STORAGE SITE A INFO - Sections A 16.1 to 16.7 16.1 to 16.7 STORAGE SITE B INFO - Sections B 16.1 to 16.7 17.1 EXPORT NON IVDs - Section 17.1 17.2 EXPORT IVDs - Section 17.2 18.1 to 18.5 ACTIVITIES -Sections 18.1 to 18.5 19.1 to 21.3 PERSONNEL INFO - Sections 19.1-21.3 22 QMS (Quality Management System) - Section 22 23 DECLARATION - Section 23 23
1. General Infmation GENERAL INFORMATION Note: If any of the details contained in this Application Fm should change after this document has been signed, the Applicant will be obliged to submit an updated application fm within 30 days, otherwise the Licence will automatically become null and void. 1.1 NAME OF PROPOSED LICENCE HOLDER Manufacturer Name: NOTE: A Manufacture Licence is granted to a person who, in the course of a business manufactures, impts, distributes expts medical devices IVDs. This can include: (i) A natural person, (ii) A legal person 1.2 NAME OF AUTHORISED REPRESENTATIVE (Natural person) Surname Initials Title Telephone number Fax number E-mail address Physical Address '(0 ) Cell Number Postal Code 24
2-3. General Infmation cont. 2.1 MANUFACTURER'S BUSINESS NAME Name of individual Registered company name if Cpation Name if trading under other business name Company Cpation Registration number issued by the Registrar of Companies Has this site previously held currently hold any licence under the Medicines and Related Substances Act? [Mark crect answer with a "X"] If YES please attach details. Confirm if details attached Enter YES NO in each case ( i.e. one box only per line) 2.2 ADDRESS FOR COMMUNICATIONS TOWN / CITY 3.1 POSTAL CODE LICENCE HOLDER CONTACT (Other than Authised Representative) Surname Initials Title Telephone number '(0 ) Cell Number Fax number E-mail address 25
4.1 NON-IVDs Manufactured in SA 4.1 LIST OF NON IVD MEDICAL DEVICES MANUFACTURED in SOUTH AFRICA Manufacturer Name: GMDN = Global Medical Device Nomenclature No. COMPANY NAME GMDN CODE GMDN Descript 1 2 3 4 5 6 7 8 9 10 "NON IVD" = Medical device which is not an IVD Name and group family of the medical device SA Risk Classification: A B C D FDA PMA Ref No. F Class C and Class D Medical Devices (NON - IVDs) - where held CE Marking Ref No. TGA Reg No. Health Canada Reg No. Japan Reg. No. ANVISA Reg. No WHO Pre Qual. Reg. No (IVDs) Company Name; GMDN Code GMDN Descript Name group family of medical device SA risk classification A / B/ C/ D F Class C & D Medical Devices: FDA PMA Ref No. CE Marking Ref No. TGA Reg No. Health Canada Reg No. Japan Reg. No. ANVISA Reg. No 26
4.2 IVDs manufactured in SA 4.2 LIST OF IVD MEDICAL DEVICES MANUFACTURED in SOUTH AFRICA Manufacturer Name: "IVD" = In Vitro Medical Device GMDN = Global Medical Device Nomenclature No. COMPANY NAME GMDN CODE GMDN Descript Name and group family of the medical device SA Risk Classification: A B C D FDA PMA Ref No. F Class C and Class D Medical Devices (IVDs) - where held CE Marking Ref No. TGA Reg No. Health Canada Reg No. Japan Reg. No. ANVISA Reg. No WHO Pre Qual. Reg. No (IVDs) 1 2 3 4 5 6 7 8 9 10 Company Name; GMDN Code GMDN Descript Name group family of IVD SA risk classification A / B/ C/ D F Class C & D Medical Devices: FDA PMA Ref No. CE Marking Ref No. TGA Reg No. Health Canada Reg No. Japan Reg. No. ANVISA Reg. No WHO Pre Qual Reg No. 27
4.3 NON IVDs Impted into SA 4.3 LIST OF NON IVD MEDICAL DEVICES IMPORTED INTO SOUTH AFRICA Manufacturer Name: GMDN = Global Medical Device Nomenclature No. COMPANY NAME GMDN CODE GMDN Descript 1 2 3 4 5 6 7 8 9 10 "NON IVD" = Medical device which is not an IVD Name and group family of the medical device SA Risk Classification: A B C D Class C & Class D International Manufacturer Name International Manufacture Site Physical Address Company Name; GMDN Code GMDN Descript Name group family of medical device SA risk classification A / B/ C/ D F Class C & D Medical Devices International Manufacturer Name International Manufacture Site Physical Address FDA PMA Ref No. CE Marking Ref No. TGA Reg No. Health Canada Reg No. Japan Reg. No. ANVISA Reg. No F Class C and Class D Medical Devices (NON - IVDs) - At least one "ORIGINATING APPROVAL" to be supplied FDA PMA Ref No. CE Marking Ref No. TGA Reg No. Health Canada Reg No. Japan Reg. No. 28 ANVISA Reg. No
4.4 IVDs impted into SA 4.4 LIST OF IVD MEDICAL DEVICES IMPORTED INTO SOUTH AFRICA Manufacturer Name: GMDN = Global Medical Device Nomenclature No. COMPANY NAME GMDN CODE GMDN Descript 1 2 3 4 5 6 7 8 9 10 "IVD" = In Vitro Medical Device Name and group family of the medical device SA Risk Classification: A B C D Class C & Class D International Manufacturer Name International Manufacture Site Physical Address F Class C and Class D Medical Devices (NON - IVDs) - At least one "ORIGINATING APPROVAL" to be supplied FDA PMA Ref No. CE Marking Ref No. TGA Reg No. Health Canada Reg No. Japan Reg. No. ANVISA Reg. No WHO Pre Qual. Reg. No (IVDs) Company Name; GMDN Code GMDN Descript Name group family of IVD SA risk classification A / B/ C/ D F Class C & D Medical Devices International Manufacturer Name International Manufacture Site Physical Address FDA PMA Ref No. CE Marking Ref No. TGA Reg No. Health Canada Reg No. Japan Reg. No. ANVISA Reg. No WHO Pre Qual Reg No. 29
5. Manufacturing Site Infmation A, B, C A 5.1 MANUFACTURING SITE "A" INFORMATION Please complete separate WORK SHEETS f each site where manufacturing and/ packing activities and / refurbishing and/ servicing and/ warehousing and/ distribution take place Manufacturer Name: SITE NAME 5.2 SITE ADDRESS TOWN / CITY POSTAL CODE Has this site previously held any licence under the Act? YES NO? YES NO 5.3 If YES please attach details SITE MASTER FILE (Tick the appropriate block) Enclosed: YES NO Submitted befe : YES NO? Site Master File previously submitted must not be older than 2 years. YES NO 5.4 SITE MASTER FILE NUMBER (if known) 5.5 SUPPLY LICENCE NUMBER AND COPY OF LICENCE FOR THE PREMISES OBTAINED FROM THE DEPARTMENT OF HEALTH (if relevant) 30
6-8. Manufacturing Site Infmation A, B, C cont. 6 SITE CONTACT (AUTHORISED DESIGNATED PERSON) Surname Initials Title Telephone number Fax number E-mail address '(0 ) '(0 ) 7 SITE USAGE Describe below any other activities on this site which are not connected with medical devices IVDs. 8 ACTIVITIES AT SITE If the Licence is f Packing only, go to section 10. Preparation of sterile products is classified as manufacture not as packing. Identify all types of medical devices manufactured on site by marking with "YES" where appropriate f each categy / type of production Type of Medical Device Risk Class of Medical Device A B C D Sterile Measuring device Blood stage transptatio n product <60 min Invasive medical device >60 min & < 30 days >30 days In-active Active Noninvasive Contraceptive Combination medical device 31
9&10. Manufacturing Site Infmation A, B, C cont. 9. NATURE of STERILISATION Sterilisation processes used (f products components): Steam steam / air Dry heat Irradiation / electron beam Biocidal gas / chemical Ethylene oxide Liquid chemical sterilisation Other - provide details Enter YES NO in each case ( i.e. one reply only per line) YES NO Notes / comments (when needed) 10. NATURE OF PRODUCTS PACAKED Identify all types of medical devices packed on site Packing of sterile products is classified as manufacture, not as packing. Please mark with "YES" where appropriate f each categy / type of packing conducted Type of Medical Device Class of Medical Device Contraceptive Measuring medical device Blood stage transptation product <60 min Invasive Medical Device Non-invasive In-active Active >60 min & < 30 days >30 days Combination medical device A B C D 32
11-13 Manufacturing Site Infmation A, B, C cont. 11 PACKING ACTIVITIES ONLY Packing of sterile products is classified as manufacture, not as packing. Enter YES NO in each case ( i.e. one reply only per line) YES NO Primary packing Labelling of primary containers Secondary packing 12 Labelling of secondary containers Assembly of kits / procedure packs OTHER DOSAGE FORMS MANUFACTURED AND/OR PACKED Enter YES NO in each case ( i.e. one reply only per line) YES NO Medicines Veterinary premixes / feed mills Any other medicinal products not listed elsewhere in this application Please specify: 13 OTHER SPECIFIC PROCESSES / ACTIVITIES Enter YES NO in each case ( i.e. one reply only per line) Fm / fill / seal processes Strip and / blister packing Packing of parallelimpted products Manufacture and / packing f expt YES NO 33
14-16.3 Manufacturing Site Infmation A, B, C cont. 14. NATURE OF MEDICAL DEVICES SERVICED AND/OR REFURBISHED Identify all types of medical devices service and refurbished on site. Please mark with "YES" where appropriate f each categy / type of medical device service / refurbished Invasive Class of Medical Device A Measuring <60 min >60 min & < 30 days >30 days Active In-active B C D 15. 15.1 ANALYTICAL TESTING SITES This refers to the site(s) at which analysis testing of starting materials, packaging materials, intermediate, bulk and finished products takes place. This may also include one me of the sites where manufacture and/ packaging also takes place. SITE NAME 15.2 Site Address 15.3 TOWN / CITY POSTAL CODE Testing activities at this site Enter YES NO in each case ( i.e. one reply only per line) YES NO Chemical / physical Microbiological / sterility / environmental / LAL Pyrogens (rabbit test method) Bioassay Stability testing Other, please specify: 34
16. Stage Facility A, B, C A 16 A 16.1 Please complete separate fms f each site at which stage, distribution other activities take place Manufacturer Name: STORAGE AND HANDLING OF FINISHED GOODS SITE NAME 16.2 SITE ADDRESS TOWN / CITY 16.3 POSTAL CODE Site Contact Surname Initials Title Telephone number '(0 ) Fax number E-mail address 16.4 Site Usage Is this site used f distribution only (i.e. onward dispatch of ready packed ders)? Is this site used f other purposes? If yes, please specify these other purposes (e.g. der receipt, invoicing, picking of ders, handling of goods returned from customers): Enter YES NO in each case ( i.e. one reply only per line) YES NO 35
16. Stage Facility A, B, C cont. 16.5 Facilities on site Is the description of the facilities available f the stage and distribution of medical devices detailed in the Site Master File? YES NO? If not, please provide a brief description (approximately 500 wds) of the facilities available f the stage and distribution of medical devices. Enter YES NO 16.6 Equipment on site Is a description of the maj items of equipment other than transpt available f the stage and distribution of medical devices detailed in the Site Master File? YES NO? If not, please provide a brief description (approximately 500 wds) of the equipment available f the stage and distribution of medical devices. In particular please provide details of any refrigeration equipment available. Enter YES NO 16.7 Activities of site relating to Impt Expt Are medical devices impted by the Applicant? YES NO? Enter YES NO Are medical devices expted by the Applicant? Yes NO? If yes, please provide a list of products being expted on Wksheet "Expt". 36
17.1 Expt Non IVDs 17.1 LIST OF NON IVD MEDICAL DEVICES EXPORTED from SOUTH AFRICA Manufacturer Name: GMDN = Global Medical Device Nomenclature No. COMPANY NAME GMDN CODE GMDN Descript 1 2 3 4 5 6 7 8 9 10 "NON IVD" = Medical device which is not an IVD Name and group family of the medical device SA Risk Classification: A B C D COUNTRIES WHERE EXPORTED TO: Company Name; GMDN Code GMDN Descript Name group family of medical device SA risk classification A / B/ C/ D Countries where expted to 37
17.2 Expt IVDs 17.2 LIST OF IVD MEDICAL DEVICES EXPORTED from SOUTH AFRICA Manufacturer Name: "IVD" = In Vitro Device GMDN = Global Medical Device Nomenclature No. COMPANY NAME GMDN CODE GMDN Descript Name and group family of the medical device SA Risk Classification: A B C D COUNTRIES WHERE EXPORTED TO: 1 2 3 4 5 6 7 8 9 10 Company Name; GMDN Code GMDN Descript Name group family of IVD SA risk classification A / B/ C/ D Countries where expted to 38
18. Activities 18 SPECIFY THE ACTIVITIES TO BE PERFORMED (Details will reflect on Licence issued) LIST OF ACTIVITIES 18.1 Manufacturer Name: MANUFACTURING ACTIVITIES Sterile Medical Device Manufacture (includes primary packing, but not secondary packing such as cartoning labelling). Single use Measuring medical devices Non invasive medical devices Invasive Medical devices Active medical devices In-active medical devices Contraceptive medical devices Combination medical devices Other sterile medical devices (please specify) Non-sterile Manufacture. Measuring medical devices Non invasive medical devices Invasive medical devices Active medical devices In-active medical devices Contraceptive medical devices Combination medical devices Other non-sterile medical devices (please specify) Manufacture of In Vitro Devices (IVDs). Class A IVD Class B IVD Class C IVD Class D IVD Enter YES NO in each case ( i.e. one reply only per line) Enter YES NO Enter YES NO Comments (when needed) Comments (when needed) Comments (when needed) End point Sterilisation of Medical Devices Manufacture of Radioactive Medical Devices Servicing and refurbishment of Medical Devices 39
18. Activities - cont. 18.2 PACKAGING ACTIVITIES. Enter YES NO Comments (when needed) Packing of bulk product and labelling Re-labelling redressing Cartoning secondary packing 18.3 TESTING ACTIVITIES. Enter YES NO Comments (when needed) Analytical Microbiological Sterility Stability Animal Other (please specify) 18.4 DISTRIBUTION ACTIVITIES. Enter YES NO Comments (when needed) Impt Class A medical device Impt Class B medical device Impt Class C medical device Impt Class D medical device Impt Class A IVD Impt Class B IVD Impt Class C IVD Impt Class D IVD Distribution to hospitals and retail pharmacies and other clients Class A Distribution to hospitals and retail pharmacies and other clients Class B Distribution to hospitals and retail pharmacies and other clients Class C Distribution to hospitals and retail pharmacies and other clients Class D Expt (please specify products and Class expted on a separate list ) 40
18. Activities - cont. 18.5 MATERIALS HANDLED OR STORED AT THIS SITE. Enter YES NO Comments (when needed) Combination medical devices with Penicillins Combination medical devices with Cephalospins Combination medical devices with (other) Antibiotics (to be specified on separate page) Combination medical devices with Hmones Combination medical devices with Cytostatics/Cytotoxics Bulk Pesticides, Herbicides Rodenticides Radioactive material Radioactive medical devices Other potent, toxic, sensitising hazardous materials (please specify) 41
19. Personnel Infmation Guidance notes on nomination of personnel having control PERSONNEL INFORMATION Relevant Qualifications Relevant qualifications are those relevant to the manufacture of medical devices including those in related sciences and management. Relevant Experience Relevant experience is that relevant to the manufacture (including quality management) of medical devices involving comparable good manufacturing practice experience, which the applicant believes should be taken into consideration as relevant. All applications should include a relevant CV and each Authised Representative nomination shall include a letter of appointment by the licence holder and signature of acceptance. 19 THE AUTHORISED REPRESENTATIVE Manufacturer Name: 19.1 Personal infmation Surname Given names Position in Company 19.2 Relevant qualifications Degree/Diploma Field of Study Institution Year Graduated 19.3 Relevant experience (current job first) Employer Number of Years in position Previous Employer Position Held Number of Years in position 42
19, 20 Personnel Infmation - cont. 19.4 Business Address and Phone number TOWN / CITY POSTAL CODE I confirm that the above particulars are to the best of my knowledge and belief accurate and true. I agree to be nominated as the Authised Representative responsible f the manufacture, impt expt of medical devices as detailed in this licence application. Signed (Authised Date: Representative): Signed (designee): Date: 20 20.1 NOMINATION OF PERSON WHO WILL HAVE CONTROL OF MANUFACTURE, IMPORT, DISTRIBUTION and EXPORT Personal infmation Surname Given names Position in Company 20.2 Relevant qualifications Degree/Diploma Field of Study Institution Year Graduated 20.3 Relevant experience (current job first) Employer Number of Years in position Previous Employer Position Held Number of Years in position 43
21 Personnel Infmation - cont. 21 21.1 PERSON WHO WILL HAVE CONTROL OF QUALITY CONTROL / ASSURANCE Personal infmation Surname Given names Position in Company 21.2 Relevant qualifications Degree/Diploma Field of Study Institution Year Graduated 21.3 Relevant experience (last job first) Employer Number of Years in position Previous Employer Position Held Number of Years in position 44
22. Quality Management System (QMS) 22 CURRENT QUALITY MANAGEMENT SYSTEM CERTIFICATION: Manufacturer Name: SITE ADDRESS QMS STANDARD YES NO SCOPE Expiry date: NAME CONFORMITY ASSESSMENT BOD COMPANY NAME: ISO 13485: 2013 COMPANY NAME: ISO 13485: 2016 COMPANY NAME: FDA CRF21 GMP COMPANY NAME: ISO 9001 Other, please provide full details, including expiry date where relevant. DATE of LAST INSPECTION Company Name; Site Address QMS Standard: Yes No Scope Expiry date Name Confmity assessment Body Date of last inspection 45
23 A. Declaration Applicants should note that in terms of the provisions of the Medicines and Related Substance Act, 1965 it is an offence to make false and misleading statements in connection with an application f a licence to impt, distribute expt medical devices. 23 A. A. I declare that: Yes No (i) Distribut Name: DECLARATION The distribut had a licence revoked after being granted such a licence. Enter YES NO in each case ( i.e. one box only per line) (ii) (iiii) The distribut has been convicted of an offence against the Medicines and Related Substance Act, 1965 a law of a state territy relating to medicines scheduled substances medical devices. The distribut has procedures in place to address all aspects of quality assurance, including Provider and Supplier contracts (agreements), Purchasing, Final Product handling, Stage, Facility installation, Servicing, Cleanliness, health and safety, Document control and recd retention, 46
23 A. Declaration cont. 23 A. A. I declare that: Yes No (iiii) Distribut Name: The distribut has procedures in place to address all aspects of quality assurance, including Enter YES NO in each case ( i.e. one box only per line) Regulaty control, Internal and external audits, Training, Complaint handling, Post market vigilance, Emergency plan and recalls, Quality assurance and management review, Distribution (transpt, delivery, temperature control), Expt documentation (proof of expt), (iv) (v) (vi) Change control. The medical devices manufactured distributed are safe and perfm as intended and that the medical device IVD fulfils the Essential Principles of Safety and Perfmance f Medical Devices IVDs. Full technical documentation is available f Class C and Class D medical devices The infmation provided in this application is current and crect. If parts (i) (ii) of the declaration were answered in the affirmative, details should be provided below 47
23 B. Declaration B 1. 2. 3. I / We apply f the granting / renewal (indicate by crossing out the non-applicable section ) of a Manufacturer's Licence to the proposed holder named in this application fm in respect of the activities to which the application refers. The licence to be subject to all the Standard Provisions applicable to Manufacturer's Licences under regulations f the time being in fce under Section 22C of the Medicines and Related Substance Act, 1965. The manufacturing operations are conducted only in accdance with the infmation set out in the application furnished in connection with it. To the best of my / our knowledge and belief the particulars I / we have given in this fm are crect and complete. The above declaration must be signed: in the case of a cpation company by the Authised Representative (a natural person) who is responsible to the Council f compliance with the Act. in the case of other enterprises by the owner (a natural person). Name Signature Position within Organization Note: This is a legal document. Any changes to the application once submitted must be made in writing detailing the requested variation and be signed by the authized person above. Date 48
Guidance Licence to Distribute Section # Instructions f Completion The following documents must each be completed in full; and each page must be completed in electronic fmat (MS Excel) [If the details f sections are not relevant then mark "not relevant"; the file must be named using the naming fmat as follows: "20YYMMDD_Licence_Application_f_Med_Dev_Manufacture_COMPANYNAME.xls"; the electronic file must be submitted to MCC on a memy stick CD ROM, clearly marked with the Company name; the submission must include a printed copy of each page; each page of the printed copy must be initialled in black ink on the lower right cner of the page by the Authroised Representative; the declaration must be signed in full in black ink by the Authised Representative. 1-3 General Infmation - Sections 1.1 to 3.1 [one page] 4.1 NON-IVDs MANUFACTURED in SA - Section 4.1 - NOT required f Distribut Licence 4.2 4.3 4.4 5.1-15.3 16.1-16.7 17.1 17.2 18.1-18.5 19.1-21.3 22 23 IVDs MANUFACTURED in SA - Section 4.2 - NOT required f Distribut Licence NON - IVDs IMPORTED into SA - Section 4.3 [Number of pages dependent on number of products]. IVDs IMPORTED into SA - Section 4.4 [Number of products dependent on number of products]. MANUFACTURING SITE A INFO - Sections A 5.1 to 15.3 - NOT required f Distribut Licence MANUFACTURING SITE B INFO - Sections B 5.1 to 15.3 - NOT required f Distribut Licence STORAGE SITE A INFO - Sections A 16.1 to 16.7 STORAGE SITE B INFO - Sections B 16.1 to 16.7 EXPORT NON IVDs - Section 17.1 EXPORT IVDs - Section 17.2 ACTIVITIES -Sections 18.1 to 18.5 PERSONNEL INFO - Sections 19.1-21.3 QMS (Quality Management System) - Section 22 DECLARATION - Section 23 49
Medical Device Licence Application Operational Process Complete application in Excel Print out each page of Licence application Check and then initial each page in black ink Sign the declaration (last page) Include signed printed copy with electronic application Save file onto a CD ROM using following naming fmat: 20YYMMDD_Licence_Application_f_Med_Dev_Manufacture_COMPANYNAME.xls OR 20YYMMDD_Licence_Application_f_Med_Dev_Distribute_COMPANYNAME.xls Label clearly with Company Name and Authised Rep contact details Deliver to MCC Incomplete applications will not be accepted 6 months to submit application from 1 August 2016 50
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