ARTICLE: South Africa prepares for changes to Medical Device Regulations
South Africa recently released new guidelines for implementation titled “Guideline for a License to Manufacture, Import, Export or Distribute Medical Devices & IVDs” and “Classification of Medical Devices and IVDs” on early August 2016.
The “Guideline for a License to Manufacture, Import, Export or Distribute Medical Devices & IVDs”1 document is intended to ensure that the Medicines Control Council is notified of manufacturers and the classification of manufactured medical devices in South Africa, persons importing and distributing medical devices in South Africa and the medical device risk classification, and the criteria for importation of medical devices into South Africa. The document includes the requirements for licensing with the Medicines Control Council and the requirements for license to manufacture, distribute, wholesale, import or export medical devices or IVDs. It covers Class B, Class C and Class D medical devices and In Vitro diagnostics (IVDs). Until further notice, Class A medical devices are exempt from the medical device establishment license requirement. Also, a separate guideline will be published for a license to wholesale medical devices.
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The guideline outlined the following requirements for acquiring the license to manufacture, import, distribute, or export medical devices or IVDs:
- The person referred to in Section 22(1)(b)2 of the Act must submit the following information to the Registrar in an application for a license to manufacture, import, or export and distribute a Class B, Class C or a Class D medical device in the electronic format approved and provided by the Council and available on the website www.mccza.com and in a printed and signed document.
- A list of all medical devices or IVDs imported into South Africa by product classification with the Global Medical Device Nomenclature Code (GMDN) and in the format as provided in the License Application for Medical Device Manufacture or License Application for Medical Device Import and Distribution.
- For medium to high risk (Class C) and high risk (Class D) medical device or IVD, proof of pre-market approval or registration for the medical device or IVD from at least one of the following regulatory authorities listed below. Such pre-market approval/s or registration/s submitted with an application for a license to import, distribute or export a Class C or Class D medical device or IVD will be referred to as the “originating approvals.”
- Australia’s Therapeutic Goods Administration (TGA) i.e. inclusion in the Australian Register of Therapeutic Goods
- Brazil’s ANVISA (National Health Surveillance Agency) approval and registration;
- Canada’s Medical Device License to market;
- The European Union’s CE certificate, to show conformity to all obligations for medical devices required by the Medical Devices Directives;
- Japan’s Marketing Authorization Holder (MAH) license;
- USA’s FDA Center for Devices and Radiological Health (CDRH) Premarket Approval (PMA) or Premarket Notification 510(k) clearance.
- Evidence of IVDs approved under the World Health Organization (WHO) Prequalification of In Vitro Diagnostics Programme will also be accepted.
- For a low to moderate risk (Class B) and moderate to high risk (Class C), and high risk (Class D) medical device or IVD, Certificate of Free Sale3 from country of manufacture or final assembly;
- For a moderate to high risk (Class C) and high risk (Class D) medical device or IVD, license holders must be able to provide full technical documentation on request by the Council.
- Where relevant, Certificate of Conformance/Analysis.
- Every application for a license to manufacture, import, export and distribute, as the case may be a Class B, Class C or Class D medical device or IVD must have an appointed Authorized Representative4 with the knowledge and responsibility to ensure that the correct procedures are followed at all times, including the process of importation, transportation, storage, distribution, marketing and sale.
- In order for a manufacturer, distributor, exporter, importer to be considered for issuance of a license, the company or person must have available and implemented at least the following:
- A Quality Management System such as SANS ISO 13485:20045 and SANS 14969:20066 addressing all aspects of quality assurance in place, covering contracts (agreements), purchasing, manufacturing, final product handling, storage, facility installation, servicing, cleanliness, documentation controls and records, international regulatory control, internal and external audits, training, complaint handling, emergency plan and recalls, quality assurance, management review, distribution (transport, delivery, temperature control), and export documentation (proof of export);
- Written formal agreement if any of the activities for QMS are delegated to a competent third party.
- The license issued to manufacture, import, export, distribute, as the case may be a Class B, Class C or Class D medical device or IVD, will be valid for a period of five (5) years or until the guideline is revised, whichever occurs first. The Medicines Control Council may add certain conditions to the license upon issuing a license and/or reviewing a license holder.
The “Classification of Medical Devices and IVDs”7 guideline is intended to assist manufacturers, importers, distributors and wholesalers of medical devices and IVDs in the classification of medical devices and IVDs required for the licensing of manufacturers, distributors and wholesalers and registration of medical devices or IVDs. Refer to the table below for the summarized guidelines outlined in the document.
|Rules for Classification of Medical Devices and IVDs
|Classification Levels –
- Class A: Low risk
- Class B: Low-moderate risk
- Class C: Moderate-high risk
- Class D: High risk (where risk relates to the patient or to public health)
|Classification by Level of Risk –
- Class A: no public health risk or low personal risk
- Class B: low public health or moderate personal risk
- Class C: moderate public health risk or high personal risk
- Class D: high public health risk
|The manufacturer or distributor is responsible for determining the classification of the device using a set of classification rules based on the following:
- Manufacturer’s or distributor’s intended use of the device or IVD
- Level of risk to patients, users and other persons (the probability of occurrence of harm and the severity of that harm)
- Degree of invasiveness in the human body
- Duration of use and exposure
- Manufacturer’s intended use of the device; and
- The level of risk to the patient and the public (taking into account the likelihood of harm and the severity of that harm)
|Intended use of the device is critical in determining the appropriate class. This can be obtained from:
- Information provided (Instructions For Use and Labeling)
- Advertising materials
- Design dossier (if applicable)
What Will Change
Upon full implementation of Act No. 72 of 20088 and Act No. 14 of 20159 the following provisions will be in effect:
- Establishes the South African Health Products Regulatory Authority (SAHPRA) that will replace Medicines Control Council (MCC). The current MCC Committee will be replaced by a separate board that will oversee the work of SAHPRA. The new national medicines regulatory authority will have a mandate that will include management of the registration, regulation and control of medicines, complementary medicines, clinical trials, active pharmaceutical ingredients, medical devices and in vitro diagnostic (IVD) devices,
- Appoints board members and chairperson, vice-chairperson, disqualification of board members, meetings of board and the appointment of various committees as well as the board’s dissolution,
- Empowers the board to appoint a chief executive officer (CEO) after consultation with the minister – and to require CEO to conclude a performance agreement with the board and to make the CEO accountable to the board, and
- Allows Minister of Health to prescribe acceptable and prohibited acts in consultation with the Pricing Committee on matters relating to subsidizing of medicines, medical devices and IVDs according to any rebate or incentive scheme.
Upon commencement and implementation of Government Notice No. R 66510 , the provisions for the following will take effect:
- License to manufacture, import, export or act as a distributor or wholesaler of medical devices or IVDs
- Period of validity of licensed issued and renewal of licenses,
- Including the manner of and conditions for allowing international tendering,
- Transmission of medical devices and IVDs through the Republic,
- Application for registration of a medical device or IVD
- Classification of medical devices and IVDs
- Information that must appear in the register for medical devices or IVDs,
- Registration Certificate,
- Amendment to the medical devices and IVDs register,
- Particulars to be published in the Gazette11,
- Appeal against the decision of the Council,
- Conduct of clinical trials and clinical investigations
- Method of taking samples during investigations, the certificate to be issued and reporting of analysis results,
- Adverse event reporting & vigilance, investigations
- Destruction of medical devices and IVDs,
- Seizure or medical devices and IVDs
- Compliance with Regulations
- Advertising of medical devices and IVDs,
- Labelling of medical devices and IVDs,
- Instructions for Use of medical devices and IVDs, custom-made medical devices,
- Records of implantable medical devices and custom-made medical devices.
- Offences and penalties
When Will It Change
As of the present time, no announcement or notification is being published regarding the final implementation and commencement of the Draft for the General Regulations relating to Medical Devices and IVDs. Also, finalization of the amendments for the Medicines and Related Substances Act, 1965 is still pending and no announcement or notification is being published. However, two (2) guidelines relating to licensing of manufacturers, distributors, importers and classification of medical devices and IVDs are published and implemented early this August 2016.
According to “Guideline for a License to Manufacture, Import, Export or Distribute Medical Devices & IVDs”12 document, persons who wish to manufacture, import, distribute or export a Class B, Class C or Class D medical device or IVD have six (6) months from the date of implementation of the Guideline to make an application for a license to manufacture, import, distribute or export a medical device or IVD. In this case, manufacturers have August 1, 2016 to January 31, 2017 to apply for license.
1 “Guideline for a License to Manufacture, Import, Export or Distribute Medical Devices & IVDs”
2 Act No. 14 of 2015 Section 22A(b)(1) states that “Subject to this section, no person shall sell, have his or her possession or manufacture any medicine, Scheduled substance, medical device or IVD, except in accordance with the prescribed conditions.”
3 The Certificate of Free Sale is evidence that the medical devices are legally sold or distributed in the open market, freely without restriction, and approved by the regulatory authorities in the country of origin.
4 “Authorized Representative” means any natural person, resident in the Republic of South Africa, who has the written mandate to represent a manufacturer, importer, distributor, wholesaler, retailer or service provider in the Republic and to act on his or her behalf for specified tasks with regard to the latter’s obligations and in whose name the manufacture license, distributor license, wholesaler license and or certificate of registration is issued.
5 – Date Approved: November 25, 2004 – International Relatedness: ISO 13485 – Date Reaffirmed: April 14, 2011 – Amendments: 1C:International: 2011-04-19
6 SANS 14969:2006 (ED. 1.00): Medical devices – Quality management systems – Guidance on the application of ISO 13485:2003 – Date Approved: August 23, 2006 – International Relatedness: ISO/TR 14969 – Date Reaffirmed: March 1, 2013
7 “Classification of Medical Devices and IVDs“. Doc # 8.05 – Classification of Medical Devices and IVDs. First publication released for implementation and comment (as part of Doc # 8.01 General Guideline Medical Devices and IVDs) – August 2015. Version 1 of new guidelines – July 2016 (July 26, 2016). Date for finalization/implementation – August 2016.
8 “Medicines and Related Substances Amendment Act, 2008 published on April 21, 2009″
9 “Medicines and Related Substances Amendment Act, 2015 published on January 8, 2016″
10 “Draft: General Regulations relating to Medical Devices and In Vitro Diagnostic Medical Devices (IVDs) published on July 31, 2015″
11 “Gazette” refers to “The Government Gazette or Straatskoerant” of South Africa. It is the “official organ of Government.” The Government Gazette is used by the government as an official way of communicating to the general public. The Gazette includes proclamations by the President as well as both general and government notices made by its various departments.
12 “Guideline for a License to Manufacture, Import, Export or Distribute Medical Devices & IVDs“. Doc # 16.03: Guideline for a License to Manufacture, Import, Export or Distribute Medical Devices and IVDs. Version 1: First publication released for comment – September 2015. Due date for comment – November 30, 2015. Publication for implementation – July 2016. Implementation – August 2016 (August 8, 2016).
(1) South Africa to Implement First Regulations for Devices, Diagnostics
(2) +Mass Device – South African medical device regulatory system set for implementation (August 24, 2016)
(3) Lexology – Meet SAHPRA – New Regulator of Medicines, Medical Devices and IVDs (February 29, 2016)
(4) Lexology – More regulation on medical devices – coming soon? (July 27, 2015)
(5) InSession Volume 15 Issue 7 2015 – Bill set to improve South Africa’s Healthcare