Acts & Regulations
| Questions | Answers |
|---|---|
| What is a listed product? | It is an electronic product that has been declared a Group III Hazardous Substance in terms of section 2(1)b and 3(b) by the Minister, by notice in the Gazette. This is in terms of the Hazardous Substances Act no. 15 of 1973. Read more here. |
| Which categories of products are listed products? | Regulation 1302 of 14 June 1991 specify the following categories of products as listed products. Read more here. |
| What is the definition of an importer? | It is any person who, whether as owner, consignor, consignee, agent or broker, is in possession of or in any way entitled to the custody or control of any Group III hazardous substance imported. |
| Why do you need a licence to manufacture a listed product? | The regulations are applicable to all listed electronic products and no distinction is made between products imported or manufactured in South Africa. Note that "manufacture", when used as a noun, includes assembly, production, preparation, processing, repair or any other manufacturing or maintenance process and, when used as a verb, has a corresponding meaning. |
Licensing
| Questions | Answers |
|---|---|
| Why is a licence required? | To provide for the control of electronic products that may cause injury or ill-health to or death of human beings. To also provide for the prohibition and control of the importation, manufacture, sale, use, operation, application, modification, disposal or dumping of such substances and products. |
| How do you apply for a licence to sell a listed product? | In terms of the Hazardous Substances Act, a licence is inter-alia required for the importation or manufacture of listed products. The application forms with licensing requirements can be downloaded at the following link. Read more here. The application form with required compliance information should be emailed to: nirmed.application@sahpra.org.za |
| How long does it take for a licence to be issued? | If the required information is submitted and the prescribed fee paid, a licence will be issued within 30 working days. |
| What are the costs to get a licence to import or to use a listed product? | According to Section 4(1) of the Hazardous Substances Act, a payment of a prescribed fee is required but it is currently not enacted. Please note that a licensing fee will soon be prescribed. |
| How long is a licence valid? | The licence for each individual model is issued on the strength of the fact that the intended purpose, as stated in the application form, is considered to be in agreement with the intended purpose of the device as reflected in the manufacturer's labelling and instructions for use (i.e. documentation required in terms of the certification process according to EC Directive 93/42/EEC, 2017/745/EU or 90/385/EEC, whichever is applicable). The licence for each model remains valid only while the EC compliance documentation is valid. All holders of licence(s) for electromedical devices must, on an annual basis, submit information on the current compliance documentation for those electromedical devices for a licence to remain valid. See more information under “Annual Submission of Compliance Information”. |
| Do we have to apply for a new licence for a different model of the same brand? | A licence is required for each model you intend to import. |
| Can we submit a licence application via a courier company? | We only accept electronic (email) licence applications submitted to nirmed.application@sahpra.org.za |
| Who will be processing the licence application? | The licence application will be captured by administrative personnel. The compliance information will be reviewed and processed by a scientist that is responsible for a specific listed generic product category. |
| What certification documents are required for a licence application for a electromedical device? | It is indicated on the application form viz. EC Certificate(s) issued by a notified body in terms of MDD 93/42/EEC, MDD 90/385/EEC or MDR 2017/745/EU (whichever one is applicable); and EC Declaration of Conformity by the manufacturer in terms of MDD 93/42/EEC, MDD 90/385/EEC or MDR 2017/745/EU (whichever one is applicable). |
| What indications for use of the product must be specified by the importer on the application form? | The intended purpose of the device must reflect the manufacturer's labelling and instructions for use as audited by the EU notified body. |
| Why is an agency letter required for a licence application? | We try to ensure that products imported are done via the manufacturer and that software upgrades, spare parts and hazard reports can be supplied by the manufacturer. |
| If the manufacturer has no EU Authorised Representative, can we still get a licence for a listed product? | No, it is a requirement of the Medical Device Directive or Regulations that the manufacturer appoints a Representative in the EU. If a Representative was not appointed it is also an indication that the manufacturer does not comply with the specific Directive and as such no notified body certificate could have been issued. By the “EU authorised representative” we mean any natural or legal person established in the EU Community who is explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the EU Community instead of the manufacturer with regard to the latter’s obligations under this Directive. |
| Can we still import a specific model when an updated EC certificate is not available? | No, any unlicensed listed electronic product may be seized. |
| Can we get a temporary licence if the EC certificate is not yet available? | No. |
| Do you accept compliance with the FDA requirements or any other certificates? | No, only compliance with the EC Medical Devices Directive (MDD) 93/42/EEC, 90/385/EEC or Medical Devices Regulations (MDR) 2017/745/EU (whichever one is applicable) is accepted for licensing purposes. |
| Do we have to licence accessories? | No. Note that by “accessory", we mean an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer. |
| What are the requirements for the manufacturing of a medical device in SA? | The requirements for the manufacturing of a listed electronic devices are the same as for the importation except that an agency letter is not required for manufacturing. |
| How do you make an amendment (e.g. correspondent, address, contact details, etc.) on your existing licence? | You may send an email message with the updated information to: nirmed.enquiry@sahpra.org.za |
| Do you need a new licence when there is a change of manufacturer/brand? | Yes, you have to submit a new licence application and include the required compliance information. |
| Can a reconditioned device be imported? | A reconditioned or refurbished electromedical device may be imported if it complies with the same requirements for new devices, as indicated on the application form. The Declaration of Conformity must be issued by the refurbishing company. |
| Can pre-owned devices be imported? | No, unless they were refurbished by a company that was audited by an EC Notified Body, for the particular scope of devices. |
| Can Pre-owned (second hand) devices be resold? | Any listed devices that were imported under a valid licence may be resold without any restriction. |
| Can we import more than one unit of the same model? | There is no limit to the amount of units that can be imported for a particular licensed model. |
| If the brand name changes do we need a new licence? | Yes, a new licence is required if there is a name change to the brand or model of a listed device. |
| When the medical device software is modified, what action do you need to take? | None, if the name of the model remains unchanged. |
| Can we get a copy of a licence issued to another company to see which products are licensed? | No. You may enquire if a licence was issued for a particular model. |
| What are the requirements to export medical devices to any other country in Africa? | You have to comply with the requirements of the particular country. We can only declare that a licence was issued in terms of our own Act and Regulations and don’t issue licences for export. |
| What is the RC011 form? | It is a form used as per condition 03 or 04 (if applicable) of the licence. It is used to report the sale of listed electronic products producing X-rays, devices emitting non-ionising radiation such as magnetic resonance imaging (MRI) installations as well as Class 3B and Class 4 laser devices. Read more here. |
| For which devices is a licence for use required? | A licence for use is required for listed electronic products producing x-rays, devices emitting non-ionising radiation such as magnetic resonance imaging (MRI) installations as well as Class 3B and Class 4 laser devices. This is because the installation or use of the product directly contributes toward the safety of the product. In the case of devices producing non-ionising radiation, the patient, operator and the general public, for example, have to be protected against the adverse health effects of excessive exposure to electric, magnetic or electromagnetic field. |
| Do you need a licence for clinical trials? | Yes, a licence is required to do clinical trials with a listed electronic product. The application form is available here. The following information would inter alia be required:
|
| Application to import listed electronic devices | What are listed products? It is an electronic product which has been declared a Group III Hazardous Substance in terms of section 2(1)b and 3(b) by the Minister, This is in terms of the Hazardous Substances Act no. 15 of 1973. Which categories of products are listed products? Regulation 1302 of 14 June 1991 specify the electronic products as listed products: E.P. Lys Why is a licence required? To provide for the control of electronic products which may cause injury or ill-health to or death of human beings. To also provide for the prohibition and control of the importation, manufacture, sale, use, operation, application, modification, disposal or dumping of such substances and products. How do you apply for the registration to sell a listed product? According to the Hazardous Substances Act, a licence is inter alia required for the importation or manufacture of listed products. The application form with licensing requirements is available at on the website and be downloaded: Application for Licence to Import a New Listed Electromagnetic Product What is the definition of an importer? It is any person who, whether as owner, consignor, consignee, agent or broker, is in possession of or in any way entitled to the custody or control of any grouped hazardous substance imported. How do I send an application of listed electronic products: Through email address: nirmed.enquiry@sahpra.org.za How long does it take for a licence to be issued? If the required information is submitted and the prescribed fee paid, a licence will be issued within 30 working days. What is the licensing fee? There is currently no prescribed fee enacted by Regulation(s). How long is a licence valid? The licence for each individual model is issued on the strength of the fact that the intended purpose, as stated in the application form, is considered to be in agreement with the intended purpose of the device as reflected in the manufacturer's labelling and instructions for use (i.e. documentation required in terms of the certification process according to EC Directive 93/42/EEC, 2017/745/EU or 90/385/EEC, whichever is applicable). The licence for each model remains valid only while the EC compliance documentation is valid. All holders of licence(s) for electromedical devices must, on an annual basis, submit information on the current compliance documentation for those electromedical devices for a licence to remain valid. What are the required supporting documents for licence to import listed electronic products? >Annexure 1: Completed application form 41BM-1(IMP); and >Annexure 2: Colour brochure (including technical specifications); and >Annexure 3: Letter of appointment as the sole authorised agent/representative of the original manufacturer in South Africa; and >Annexure 4: EC Certificate(s) issued by a Notified Body in terms of MDD 93/42/EEC, MDD 90/385/EEC or MDR 2017/745/EU (whichever one is applicable); and >Annexure 5: EC Declaration of Conformity by the manufacturer in terms of MDD 93/42/EEC, MDD 90/385/EEC or MDR 2017/745/EU (whichever one is applicable) |
| Application of licence to manufacture a listed product | Why do you need a licence to manufacture a listed product? The Regulations are applicable to all listed electronic products and no distinction is made between products imported or manufactured in South Africa. Note that "manufacture", when used as a noun, includes assembly, production, preparation, processing, repair or any other manufacturing or maintenance process and, when used as a verb, has a corresponding meaning. What indications for use of the product may be specified by the importer? The intended purpose of the device must reflect the manufacturer's labelling and instructions for use as audited by the EU Notified Body. What is a Notified Body? A Notified Body is an organisation designated by an EU Member State (or by other countries under specific agreements) to assess the conformity of certain products before being placed on the market. The Notified Body is entitled to carry out tasks related to conformity assessment procedures set out in the applicable legislation when the intervention of a third party is required. What is the difference between a Notified Body certificate and a Declaration of Conformity issued in terms of the EC Directives? A Notified Body is an accredited third party that issue a certificate, based on an audit in terms of a specific EC Directive. The manufacturer, or his EU authorised representative is obliged to issue an EU Declaration of Conformity for a specific product model. It is a conformity assessment procedure required by the Directive before a product can be placed on the market. For which devices is a licence for use required? A licence for use is required for listed electronic products producing X-rays, devices emitting non-ionising radiation such as magnetic resonance imaging (MRI) installations as well as Class 3B and Class 4 laser devices. This is because the installation or use of the product directly contributes toward the safety of the product. In the case of devices producing non-ionising radiation the patient, operator and the general public, for example, have to be protected against the adverse health effects of excessive exposure to electric, magnetic or electromagnetic fields. Why is an agency letter required for a licence application? We try to ensure that products imported are done via the manufacturer and that software upgrades, spare parts and hazard reports can be supplied by the manufacturer. Do you follow the RoHS? The Restriction of (the use of certain) Hazardous Substances in electrical and electronic equipment is an EU legislation. We support the efforts to reduce the harmful effects of dangerous substances to people and the environment, but it is not a prescription of the Hazardous Substances Act. If the manufacturer has no EU Authorised Representative, can we still get a licence for a listed product? No, it is a requirement of the Medical Device Directive or Regulations that the manufacturer appoints a Representative in the EU. If a Representative wasn’t appointed the it is also an indication that the manufacturer doesn’t comply with the specific Directive and as such no Notified Body certificate could have been issued. By the “EU authorised representative” we mean any natural or legal person established in the EU Community who is explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the EU Community instead of the manufacturer with regard to the latter’s obligations under this Directive Where can the status of license application be verified? Please send an email to nirmed.enquiry@sahpra.org.za Do we have to licence accessories? No. Note that by “accessory" we mean an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer. Who will be processing the licence application? The licence application sent to the email address indicated on the application form nirmed.enquiry@sahpra.org.za will be captured by the administrative personnel. The compliance information will be reviewed and processed by a Scientist that is responsible for a specific listed generic product category. What is the costs to get a licence to import or to use a listed product? According to Section 4(1) of the Hazardous Substances Act, a payment of a prescribed fee is required but it is currently not enacted. How do you change the information for the correspondent, address, etc? You may send an email message with the updated information. Do you need a new licence when there is a change of manufacturer/brand? Yes, you have to submit a new licence application and include the required compliance information. Do we have to comply with ICASA requirements? In accordance with the ICASA Act and the Electronic Communications Act, ICASA is responsible for the licensing of broadcasting services, electronic communication services and postal services. Licensing in terms of the ICASA Act is not a requirement of the Hazardous Substances Act. Do we have to apply for a new licence for a different model of the same brand? A licence is required for each model you intend importing. What certification documents are required for a licence application for a electromedical device? It is indicated on the application form viz. EC Certificate(s) issued by a Notified Body in terms of MDD 93/42/EEC, MDD 90/385/EEC or MDR 2017/745/EU (whichever one is applicable); and EC Declaration of Conformity by the manufacturer in terms of MDD 93/42/EEC, MDD 90/385/EEC or MDR 2017/745/EU (whichever one is applicable). A confirmation letter issued by the MDR Notified Body stating the receipt of the manufacturer’s application for conformity assessment (since 26 May 2024) and the conclusion of a written agreement is also required as of 26 September 2024. What are the requirements for the manufacturing of a medical device in SA? The requirements for the manufacturing of a listed electronic device is the same as for the importation except that an agency letter is not required for manufacturing. Can a reconditioned device be imported? A reconditioned or refurbished electromedical device may be imported if it complies with the same requirements for new devices, as indicated on the application form. The Declaration of Conformity must be issued by the refurbishing company. Can pre-owned devices be imported? No, unless they were refurbished by a company that was audited by a EC Notified Body, for the particular scope of devices. Can Pre-owned (second hand) devices be resold? Any listed device that were imported under a valid licence may be resold without any restriction. Can we get a temporary licence if the EC certificate is not yet available? No. Do you accept compliance with the FDA requirements or any other certificates? No, only compliance with the EC Medical Devices Directive(MDD) 93/42/EEC, 90/385/EEC or Medical Devices Regulations (MDR) 2017/745/EU (whichever one is applicable) is accepted for licensing purposes. What are the requirements to export medical devices to any other country in Africa? You have to comply with the requirements of the particular country. We can only declare that a licence was issued in terms of our own Act and Regulations. Can we import more than one unit of the same model? There is no limit to the amount of units that can be imported for a particular licensed model. If the brand name changes do we need a new licence? Yes, a new licence is required if there is a name change to the brand or model of a listed device. When the medical device software is modified, what action do you need to take? None, if the name of the model remains unchanged Can we get a copy of a licence issued to another company to see which products are licensed? No. You may enquire if a licence was issued for a particular model. An email may be send to: nirmed.enquiry@sahpra.org.za What is the RC011 form It is a form used as per condition 03 or 04 (if applicable) of the licence. It is used to report the sale of listed electronic products producing X-rays, devices emitting non-ionising radiation such as magnetic resonance imaging (MRI) installations as well as Class 3B and Class 4 laser devices. Do we also need registration from SAHPRA in Pretoria? The medical device unit of SAHPRA (in Pretoria) regulates the licensing of medical device establishments and the registration of medical devices (In vitro diagnostics (IVDs) and non-IVD medical devices) that are not licensed by Radiation Control unit in Bellville. This is to ensure the availability of medical devices that comply with an acceptable level of safety, quality and performance. Please see: Medical Devices. Can we submit a licence application via a courier company? We only accept electronic (email) licence applications. Can we still import a specific model when an updated EC certificate is not available? No, any unlicensed listed electronic product may be seized. We only need to do clinical trials, do we need a licence? A licence is required to do clinical trials with a listed electronic product. An application form 41BM-1 should be used that would inter alia require: >Proof of registration of the clinical trial on the South African National Clinical Trials Register www.sanctr.gov.za, i.e. the National Register Number; >List of the medical institutions where the clinical trial will be conducted; >List of the medical practitioners who will supervise the clinical trial; >List of the medical practitioners who will supervise the clinical trial; >Copy of the approved Research Protocol for the clinical trial; >Copy of the “Informed Consent” form. Do we need a licence to export a device? We do not issue licences for export. What may happen if you import a listed electronic product without a licence? An inspector or police official as defined in section 1(1) of the Criminal Procedure Act, 1977 (Act no. 51 of 1977), may, at any time and such manner as he may deem fit and without prior notice to any person, seize any grouped hazardous substance, appliance, vehicle or other object which is concerned in or is on reasonable grounds believed by him to be concerned in the commission or suspected commission of an offence in terms of this Act which in his opinion may afford evidence of the commission or suspected commission of such offence; or which is intended to be used or is on reasonable grounds believed by him to be intended to be used in the commission of such offence. Note that any substance, appliance, book, statement or document or other object which appears to provide proof of a contravention of any provision of the Act may also be seized. When should a defect or hazard be reported? It must be reported when it comes to the notice of an approved dealer or when an approved dealer has reason to suspect that a listed electronic product of a licensed model has a defect or fault, since it does not comply with an applicable Standard or no longer fits the description of such model contained in the licence application. |
| Application of Licence to use Lasers Class 3B and 4 | What is the training requirements of a Laser Safety Officer (LSO)? It is only specified that management (the employer) shall establish and maintain an adequate program for the control of laser hazards. An individual shall be designated the Laser Safety Officer (LSO) with the authority and responsibility to monitor and enforce the control of laser hazards for the operation, maintenance and service of a Class 3b or Class 4 laser system. The LSO may be designated from among such personnel as the radiation protection officer, industrial hygienist, safety engineer, laser specialist, laser operator, etc. |
| Annual Submission of Information Compliance (ASOCI) | When do we have to submit our annual compliance information? Condition 9 of the licence specifies the information that will be required on an annual basis, as well as the deadline for submitting this information. This information must be submitted in the prescribed format, utilising form 41BM-2. This form containing the applicable list of licences for an individual licence holder, would be e-mailed (whenever possible) to that licence 1 month before the deadline for submission. The deadline for submission, by which the required information must be submitted by licence holders, has been staggered over a period of 8 months. Licence holders have been divided alphabetically into more or less equal groups, depending on the total number of licences involved. Licence holders whose names start with “A” or “B” must submit before 1 April, “C” to “F” before 1 May, “G” or “H” before 1 June, “I” to “L” before 1 July, “M” before 1 August, “N” to “R” before 1 September, “S” before 1 October, and “T” to “Z” before 1 November. Why are some licences previously issued not displayed on the Annual list? The Annual submission is only applicable to a licenced model issued with Condition 9 and also if the licence for that model is older than one year. How much time do we have to submit the information? The licence holder has about a month within which to submit the required information. Is the same information from the previous year still applicable? The information submitted for a previous year could still be applicable if the Notified Body certificate hasn’t expired. Can we still import a specific model when an updated EC certificate is not available? No Do we need to submit a copy of the Notified Body certificate with our annual submission? No, unless it is asked for by a reviewer of the submission. |
General
| Questions | Answers |
|---|---|
| What is a Notified Body? | A Notified Body is an organisation designated by an EU Member State (or by other countries under specific agreements) to assess the conformity of certain products before being placed on the market. The Notified Body is entitled to carry out tasks related to conformity assessment procedures set out in the applicable legislation when the intervention of a third party is required. |
| What is the difference between a Notified Body certificate and a Declaration of Conformity issued in terms of the EC Directives? | A Notified Body is an accredited third party that issue a certificate, based on an audit in terms of a specific EC Directive. The manufacturer, or his EU authorised representative is obliged to issue an EU Declaration of Conformity for a specific product model. A conformity assessment procedure required by the Directive before a product can be placed on the market. |
| What are the training requirements of a Laser Safety Officer (LSO)? | It is only specified that management (the employer) shall establish and maintain an adequate program for the control of laser hazards. An individual shall be designated the Laser Safety Officer (LSO) with the authority and responsibility to monitor and enforce the control of laser hazards for the operation, maintenance and service of a Class 3b or Class 4 laser system. The LSO may be designated from among such personnel as the radiation protection officer, industrial hygienist, safety engineer, laser specialist, laser operator, etc. |
| What may happen if you import a listed electronic product without a licence? | An inspector or police official as defined in section 1(1) of the Criminal Procedure Act, 1977 (Act no. 51 of 1977), may, at any time and such manner as he may deem fit and without prior notice to any person, seize any grouped hazardous substance, appliance, vehicle or other object which is concerned in or is on reasonable grounds believed by him to be concerned in the commission or suspected commission of an offence in terms of this Act which in his opinion may afford evidence of the commission or suspected commission of such offence; or which is intended to be used or is on reasonable grounds believed by him to be intended to be used in the commission of such offence. Note that any substance, appliance, book, statement or document or other object which appears to provide proof of a contravention of any provision of the Act may also be seized. |
| When should a defect or hazard be reported? | It must be reported when it comes to the notice of an approved dealer or when an approved dealer has reason to suspect that a listed electronic product of a licensed model has a defect or fault, since it does not comply with an applicable standard or no longer fits the description of such model contained in the licence application. |
| Do you follow the RoHS? | The Restriction of (the use of certain) Hazardous Substances in electrical and electronic equipment is an EU legislation. We support the efforts to reduce the harmful effects of dangerous substances to people and the environment, but it is not a prescription of the Hazardous Substances Act. |
| Do we have to comply with ICASA requirements? | In accordance with the ICASA Act and the Electronic Communications Act, ICASA is responsible for the licensing of broadcasting services, electronic communication services and postal services. Licensing in terms of the ICASA Act is not a requirement of the Hazardous Substances Act. |
| Where is the SAHPRA head office located? | Building A, Loftus Park, 402 Kirkness street, Arcadia, Pretoria. |
| Where is the Radiation Control unit of SAHPRA located? | Avanti Office Park North, 35 Carl Cronje Drive, Tygervalley, Bellville, Cape Town. |
Annual Submission of Compliance Information
| Questions | Answers |
|---|---|
| What is the Annual Submission of Compliance Information (ASOCI)? | It is the compliance information that must be submitted by licence holders annually to keep a licence(s) valid. |
| When do we have to submit our annual compliance information? | Condition 9 of the licence specifies the information that will be required on an annual basis, as well as the deadline for submitting this information. This information must be submitted in the prescribed format. This form containing the applicable list of licences for an individual licence holder, would be e-mailed (whenever possible) to that licence holder one month before the deadline for submission. The deadline for submission, by which the required information must be submitted by licence holders, has been staggered over a period of 8 months. Licence holders have been divided alphabetically into more or less equal groups, depending on the total number of licences involved. Licence holders whose names start with “A” or “B” must submit before 1 April, “C” to “F” before 1 May, “G” or “H” before 1 June, “I” to “L” before 1 July, “M” before 1 August, “N” to “R” before 1 September, “S” before 1 October, and “T” to “Z” before 1 November. |
| Why are some licences previously issued not displayed on the Annual list? | The Annual submission is only applicable to a licenced model issued with Condition 9, and also if the licence for that model is older than one year. |
| How much time do we have to submit the information? | The licence holder has about a month within which to submit the required information. |
| Is the same information from the previous year still applicable? | The information submitted for a previous year could still be applicable if the Notified Body certificate hasn’t expired. |
| Can we still import a specific model when an updated EC certificate is not available? | No. |
| Do we need to submit a copy of the Notified Body certificate with our Annual submission? | No, unless it is required at a later stage during the review process. |