Medicines and Related Substances Act, 1965
R 385
Occupational Health and Safety Act, 1993 (Act No. 85 of 1993)Guidance NotesPressure Equipment Regulations, 2009Regulation 5 - Duties of Importers and Suppliers |
| (1) | Importers and suppliers shall ensure that pressure equipment sold complies with the requirements of this Regulation. |
| (2) | The importer shall assume the liability of the manufacturer in terms of this Regulation. |
| (3) | Any pressure equipment that requires a permit to be issued by an organisation approved by the chief inspector shall ensure that such approval is obtained by the importer or manufacturer before the pressure equipment is placed in the market: Provided that such equipment shall comply with the relevant health and safety standard incorporated into these Regulation under section 44 of the Act. |
Notes:
| (a) | The importer is the entity which imports pressure equipment for use and/or re-sale in South Africa. The importer must be a juristic person in RSA. |
| (b) | The importer of pressure equipment into the RSA assumes the liability of the manufacturer and must declare conformance in writing to the PER. This conformity assessment review shall be countersigned by an AIA as applicable. The AIA shall only verify conformity assessment reviews for imported pressure vessels, steam generators and assemblies for Category II equipment and higher. |
| (c) | Category I equipment and below does not require verification of the conformity assessment review by the AIA. |
| (d) | Where users or their agents appoint entities to manage procurement and construction of imported pressure equipment, this entity is in overall control and is deemed the importer. |
| (e) | The permit referenced in PER 5(3) is applicable to fire extinguishers in accordance with SANS 1475, LPG cylinders to SANS 10019 and other verification schemes as mandated by the Chief Inspector. |
| (f) | Importer shall ensure that the foreign inspection and certification bodies meets the requirements of PER 7(3)(b) with respect to ISO 17020, 17021 or higher accreditation and scope of accreditation together with the applicable health and safety standard. |
| (g) | Series produced pressure equipment with type test certification and a declaration of conformity by the manufacturer may be conformity assessed by the importer and verified by an AIA where applicable using a once off conformity assessment review certificate for that type provided the manufacturer and notified body and the country of origin remains the same. |
| (h) | Imported pressure vessels, safety accessories and pressure accessories categorised under the PED need not be re-categorized in accordance with SANS 347 where the fluid group differs. |
| (i) | Reasonable steps required from the Importer to fulfil his liability as the manufacturer are: |
| (i) | The Importer is obligated to perform a conformity assessment review in accordance with SANS 347 and issue a conformity assessment review certificate with a verification signature by the Importer appointed Approved Inspection Authority (AIA) as applicable. |
| (ii) | The Importer shall ensure that the equipment has been categorized and submitted to the applicable conformance assessments of SANS 347 or Pressure Equipment Directive as applicable (see subregulation 3.(3)). |
| (iii) | The Manufacturer is obliged to ensure that the pressure equipment has been constructed in full accordance with a relevant health and safety standard (see subregulation (4.(1)) with the Importer only required to verify that the health and safety standard used by the Manufacturer for construction is listed in SANS 347. |
| (iv) | The pressure equipment is provided with a certificate of manufacture which reflect the verification of an approved inspection authority (AIA), Authorized Inspector (AI) or Notified Body (NB) when so required (see subregulation 4.(3)). |
| (v) | Ensuring that the approved inspection authority (AIA), Authorized Inspector (AI) or Notified Body (NB) meets the requirements stipulated in subregulation 7 and guide note (c). |
| (vi) | The pressure equipment marking satisfies the requirements of subregulation 9 through the addition of an additional data plate by the Importer if required. The additional data plate does not need to reference the importer. |
| (vii) | Pressure equipment and/or assemblies are fitted with the required safety accessories as required by subregulation 10. |
| (viii) | The Importer shall ensure that the provided documentation accompanying the imported equipment satisfies the requirements of subregulation 14. In the case of assemblies the Importer shall ensure that a global conformity assessment review certificate accompanies the assembly |
| (ix) | Confirming that the pressure equipment is in full compliance, but not limited to, the applicable PER requirements. |
