enabling effective and efficient medical devices ... · government gazette no 40480, no. 1515 4 1....
TRANSCRIPT
Enabling Effective and Efficient Medical Devices Regulations for South Africa through harmonisation: Why the
regulator has chosen to follow the GMDN system
SAMED Conference
CSIR Convention Centre
2 February 2017
Dr J. Gouws
Agenda
• Legislation
• Roadmap for licensing and Registration
• Nomenclature system
• Regulatory Experience: License applications
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Legislation: Act 101 of 1965, as amended
• Amendment Acts to current legislation [Act 101 of 1965]: oAct 72 of 2008 and Act 14 of 2015
• Provides for the establishment of a new regulatory authority (SAHPRA)
• Provides for transition of MCC to SAHPRA
• Provides for the licensing of Scheduled substance Manufacturers and Wholesalers
• Provides for expansion on the regulatory oversight of Medical Devices
• Status of the amendment : President signed the amendment - not yet promulgated
• Proposed Promulgation: 2017
• Regulations for Medical Devices & IVDs: oPublication 9 December 2016, Government Gazette No 40480, No 1515
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Regulations relating to Medical devices & IVDs Government Gazette No 40480, No. 1515
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1. Definitions
2. Manner and conditions for allowing international tendering
3. Importation of medical devices and IVDs into the Republic
4. Transmission of medical devices or IVDs through the Republic
6. Period of validity of licence issued in terms of regulation 5 and renewal of licences
7. Appeal against the decision of the Council
9. Information that must appear in the register for medical devices or IVDs
10. Amendment to the medical devices and IVDs register
12. Registration certificate
13. Parts and components
14. Destruction of medical device and IVD
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Regulations relating to Medical devices & IVDs Cont….
15. Method of taking samples during investigation, certificate to be issued and reporting of analysis results
16. Conduct of clinical trials and clinical investigations
18. Investigation
19. Offences and penalties
20.Compliance with requirements
21. Advertising of medical device or IVD
22. Labelling of medical device or IVD
23. Instructions for Use of medical device
24. Instructions for Use of IVD
25. Custom made medical devices
26. Record of implantable medical devices and custom made medical devices
29. Short title
Act 101: Section 22C(1)(b) - Licensing Section 22C(1)(b)
The Authority may, on application in the prescribed manner and on payment of the prescribed fee, issue to a medical device or IVD establishment, manufacturer, wholesaler or distributor of a medicine or Scheduled substance, medical device or IVD
• a licence to manufacture, import, export
• a licence to act as a wholesaler or distribute
• upon conditions
• as to the application of such acceptable quality assurance principles and good manufacturing and distribution practices as the Authority may determine.
Section 22C(6)
No medical device or IVD establishment, manufacturer, wholesaler or distributor referred to in subsection (1)(b) shall manufacture, act as a wholesaler of or distribute, as the case may be, any medicine, Scheduled substance, medical device or IVD unless he or she is the holder of a licence contemplated in the said subsection.
Guideline for manufacture, import , export or distribute a medical device or IVD (www.mccza.com)
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http://www.mccza.com/Publications
Section 14.
(1) …. no person shall sell any medical device or IVD which is subject to registration by virtue of a declaration published in terms of subsection (2) unless it is registered.
(2)(a) The Authority may from time to time determine that a medical device or IVD, or class of medical device or IVD be subject to registration in terms of this Act.
(b) Any such declaration may also relate to medical devices or IVDs which were available for sale in the Republic immediately prior to the date on which it comes into operation or to new medical devices or IVDs which were not then available.
(c) Any such declaration shall be published in the Gazette by the CEO and shall come into operation on the date on which it is so published.
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Act 101: Section 14. Prohibition on the sale of medicines, medical devices or IVDs which are subject to registration and are not
registered
Regulation 11: Classifications of medical devices and IVDs·
• The following are the classes of medical devices and IVDs:
(a) Class A Low Risk;
(b) Class 8 Low-moderate Risk; ( c) Class C Moderate-high Risk; (d) Class D High Risk,
where risk relates to the patient, user or to public health.
• Medical devices (except custom made medical devices) and IVDs must be registered with the Council in terms of call up notices before they may be sold or used in the Republic.
•The Council determine the classification of medical devices and IVDs according to classification rules.
• Where the classification of a medical device or IVD places it in more than one class it will be placed in the higher class. •
•Classification is done based on design and intended use.
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A B C D
Device Risk
Co
ntr
ol L
evel
“user" means a person or organisation that uses a medical device or IVD
Regulation 17: Adverse event reporting & vigilance
o The Applicant must inform the Council
• within a specific time frame of a suspected adverse event, reported to him or her, occurring as a result of the use of the medical device or IVD
• steps to be taken to address the adverse event
• conduct a concise critical analysis of the safety and performance of the medical device or IVD and submit the results thereof to the Council
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Regulation 17: Adverse event reporting & vigilance …cont.
•After receipt of the ADE results and Council determines that the medical device or IVD may not be safe to use the Applicant to submit
• case reports of suspected medical device adverse events
•medical device or IVD usage figures, periodic safety update reports and performance studies
• any other data requested by the Council.
•Applicants to keep and maintain or have access to records of the ADE data
• Any person / user can report an ADE to Council or the Applicant / Manufacturer/ authorised representative
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Regulation 28: Transitional arrangements regarding unregistered medical devices & IVDs
o The Council shall issue a notice in the Gazette calling for the registration of medical devices and IVDs which notice must-
• stipulate which classes of medical devices and IVDs must be registered
• provide for the conditions and time periods for the application for registration.
oUnregistered medical device or lVD sold in the Republic at the time of the commencement of these Regulations is, considered to be sold legally until such time as the call-up notice period for the medical device or lVD has expired.
oEven if not yet called up the Council may require a medical device or IVD to comply with the requirements that the Council may determine in order to ensure that the medical device or lVD meets the Essential Principles of safety and performance
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Regulation 28: Transitional arrangements regarding unregistered medical devices & IVDs …cont
• Transitionary arrangements applies for medical devices on market
as on 9 Dec 16
• Medical devices will be called up for registration by class:risk based approach • NEW medical devices (i.e. not on market at 9 December 16 and not yet called
up) may be placed on the market [GG Notice to call up all New Medical Devices for Class B, C, D as GG Printer for publication]
• NEW medical devices (as from the date of publication of the call up notice may NOT be placed on the market
• General Guideline for Medical Devices – Registration process for Class B, Class C and Class D medical devices and IVDs
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Guideline for Licensing of medical device establishment
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• Establish relevant quality assurance criteria for manufacture of medical devices in South Africa
• Identify requirements for importation of Medium to High risk and High risk medical devices
• Establish relevant distribution practices for distributors in South Africa
• Establish a list (data base) of all medical devices imported and manufactured in South Africa by risk classification, by manufacturer or by distributor.
• Details of Manufacturers, Distributors & respective Authorised Representatives
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1. Licence to manufacture medical device or IVD • Import
• Manufacture & distribute
• Export
2. Licence to distribute medical device or IVD • Import
• Distribute
• Export
3. Licence to wholesale medical device or IVD
3. K
Guideline for Licensing of medical device establishment …cont
Phase 1
Phase 2
Regulation 27: Transitional arrangements regarding unlicensed manufacturer, distributor and wholesaler
The Council to issue a notice in the Gazette calling for the licensing of unlicensed manufacturers, distributors and wholesalers
•The notice must stipulate: • the conditions and time periods for licensing
• during the process of licensing, the unlicensed manufacturers, distributors and wholesalers are considered to be trading legally .
•Manufacturer, distributor or wholesaler who, at the time of the commencement of these Regulations, and the publication of the Cal lup notice sells medical devices or IVDs in the Republic is without an application submitted to MCC considered to be trading legally
•Callup Notice is with Government Gazette Printer awaiting publication
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Roadmap for Licensing and Registration of Devices:Listing Rationale : GHTF/SG1/N065:2010 Aug 27, 2010
“In many jurisdictions where regulations for medical devices are introduced for the first time, the initial step in the process is often the collection by the RA of information relating to:
• the types of medical devices supplied to the market,
• the manufacturers of these devices, and
• other parties responsible for supplying them to the market in that jurisdiction.
Having established databases that contain such information, the information is updated in response to changes in the medical devices being placed on the market, changes to parties in the supply chain and any other changes to the information provided in the first instance.
The collection and retention of this information on manufacturers, authorised representatives, importers and distributors and the medical devices supplied to the market by those parties are fundamental elements of regulatory control. Where available resources are limited, registration /listing may be the only, or primary, regulatory control that exists within a jurisdiction.
Many regulators of medical devices have incorporated registration /listing requirements into their medical device regulations. The information held is useful in facilitating regulatory actions such as compliance audits and field safety corrective actions. It may also be used for law enforcement purposes..”
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Licence to a) manufacture; b) Import & distribute or c) Wholesale
Six months notice:
Authorised Representative
Quality Management System (declaration) ----> ISO13485 (2016)
Full list of Medical Devices by company & classification
Class C & D: Evidence of pre-market authorisation in either:
USA (FDA); EU (CE marking); Japan; Canada; Australia; Brazil WHO Pre-Qualification IVD
Registration - New High Risk Medical Devices (Class C, Class D)
Technical Documentation
• including quality standard certifications – depending on risk classification
SA Authorised Representative’s Declaration of Conformance
Regulatory Road Map - Phased Implementation
SANAS: Development of Conformity Assessment Framework for Medical Devices ISO 13485 (2016)
Accreditation of South African Conformity Assessment Bodies
MOU signed by MC and SANAS
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MOU
MCC SA Regulatory
Authority The responsible “Gate Keeper”
SANAS SA Accreditation
Body
Evaluates potential Conformity Assessment Bodies on behalf of MCC vs a Standard
Conformity Assessment Bodies A B C
Perform CA services (inspection & certification) for a manufacturer/distributor placing a product on the
market in SA vs a International Standard
Manufacturer / Distributor
SA Declaration of Conformity, Registers & places product on market
X Y Z
Customer / User Purchases & uses the product
Accredits
Inspect & certify
Current status of License applications
• Based on GHTF directive to Regulatory Authorities planning to introduce a regulatory system for Medical Device and IVD’s MCC resolved: • Prepare General Regulations to Act 101 supporting regulatory oversight
• Prepare Guideline documents to advise Industry on license and registration requirements
• Initiate license process for Medical Device Establishments
• Invite Applicants to submit applications voluntary as from 1 August 2016
• Appoint an Expert Medical Device Committee to support MCC
• Publish General Regulations for Medical Devices on 9 December 2016
• Applications received to date: 30 applications for Licenses
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Current status of License applications…cont
• Desk top review of all Medical Device Establishment licenses
• Medical Device Committee consider compliant applications (25 Jan 2017)
• Council finalise call up time frame for Medical Device establishments and Wholesalers of Medical Devices
• Call up with Government Printer for publication allowing: • Medical Device establishments - 6 months call up period -deadline: Aug 2017
• Wholesalers – 12 months call up period – deadline Feb 2018
• Medical Device Applications to MCC for consideration of a license (MCC82, 16 February 2017) • MCC to issue a license with conditions
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Coding system for Medical Devices
• Nomenclature of Medical Devices is a coding system used to generically identify devices having the same features, characteristics and intended use
• Nomenclature standardize terms to facilitate: • Management • Regulation ( market surveilance, ADE incidents, recalls) • enable communication and exchange of data
• Mainly two nomenclature systems in use: • Global Medical Devices Nomenclature system (GMDN) supported by IMDRF • Universal Medical Devices Nomenclature (UMDNS)
• Question: which one to use or to develop own Nomenclature system
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Nomenclature of Medical Devices …cont
• History of the development of a Nomenclature system globally • Pre 1990 (No consistency in Regulations)
• 1993-2011 (GMDN development) • identify 16 Categories
• 19 000 preferred terms
• 1 980 collective terms
• Position statement by the GHTF (later transition to IMDRF)
• MCC is an observer to the IMDRF
• WHO usually supports IMDRF
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Nomenclature of Medical Devices …cont
• Position Statement by the Global Harmonization Task Force: Single Global Nomenclature System for Medical Devices (19th November 2010)
“…The GHTF therefore endorses the GMDN coding system as the preferred nomenclature system for regulatory purposes for medical devices and will continue to work to ensure its effective governance and availability.”
[GHTF transitioned to IMDRF (International Medical Device Regulatory Forum)]
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July 2014 status of nomenclature for medical devices globally ….[WHO data]
"nomenclature" means the common generic description as per the Global Medical Device Nomenclature for medical devices having similar features, characteristics and intended use;
GMDN coding : required for application for registration of the medical device or IVD
• Reg 8(5)(b) Application for registration including the particulars of the medical device • iv) Nomenclature system code
• Reg 9(j) Information that must appear in Medical Device or IVD Register (j) the nomenclature system code allocated to the medical device or IVD
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GHTF/SG1/N065:2010 Aug 27, 2010 IMDRF (GHTF) Guidance doc : Registration of Manufacturers and other Parties and Listing of Medical Devices 6.4 Information to be submitted for listing purposes A device code, allocated through an internationally recognised coding system, for each medical device for which listing information is required. The Global Medical Device Nomenclature (GMDN) provides the use of generic descriptors for the identification of medical devices and other healthcare related products. The nomenclature system is managed by the GMDN Agency. The code is based on the international standard EN ISO 15225.
GMDN Categories 1. Active implantable devices 2. Anaesthetic and respiratory devices 3. Dental devices 4. Electro mechanical medical devices 5. Hospital hardware 6. In vitro diagnostic devices 7. Non-active implantable devices 8. Ophthalmic and optical devices 9. Reusable devices 10. Single-use devices 11. Assistive products for persons with disability 12. Diagnostic and therapeutic radiation devices 13. Complementary therapy devices 14. Biologically-derived devices 15. Healthcare facility products and adaptations 16. Laboratory equipment
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Regulatory experience: License applications
• Presentation by Ms Andrea Julsing Keyter
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