Professional Documents
Culture Documents
NOVEMBER 2015
Prepared by:
Bernard Braun
Nadine Kadri Altourjuman
Marcello Zerbini
Elena Zuccarelli
TABLE OF CONTENTS
INTRODUCTION.................................................................................................................................2
THE SOUTH AFRICAN MEDICAL DEVICE MARKET..........................................................................2
IMPORT REGULATIONS......................................................................................................................3
MEDICAL DEVICES IMPORT REGULATIONS....................................................................................10
DISTRIBUTION CHANNELS..............................................................................................................11
SOUTH AFRICA AGENTS & DISTRIBUTORS.....................................................................................13
SUMMARY TIMELINE & COSTS......................................................................................................16
REFERENCES...................................................................................................................................18
INTRODUCTION
This report was prepared to help HSI, a US company, enter the South African Market.
Specifically, HSI wishes to export Heat Moisture Exchangers (HME) to South Africa HMEs
are medical devices used in mechanically ventilated patients to help prevent complications due to
"drying of the respiratory mucosa, such as mucus plugging and endotracheal tube (ETT)
occlusion. They are used in conjunction with medical ventilators for comatose patients or after a
major surgery and are considered consumables. In addition to standard HME devices HSI
manufactures Heat Moisture Exchangers & Filters (HMEF) devices which serve the same
purpose but add a bacterial filter meant to prevent infections.
To assist HSI, Sexy Pandas conducted research on the South African Market. Specifically this
report provides information and recommendations on the following:
South African Medical Device Market
South Africa Medical Devices Regulations
South Africa Import Regulations
Import Timelines & Costs
South Africas Medical Devices Distribution Channels (including agents and distributors)
South Africas healthcare expenditure is high by developing country standards and was recorded
as being proportional to 9% of GDP in 2013. Expenditure between the public and private sectors
is at approximately 50/50 parity although substantially more people use the public healthcare
system as opposed the private sector. This is expected to be skewed to the public sector over the
coming years with the phasing in of the National Health Insurance (NHI).
The South African medical devices market (consumption, production and trade) is estimated at
US$1.2 billion and is forecast to grow at a US$ billion Compound Annual Growth Rate (CAGR)
of 7.74% between 2013 and 2018. The reasons underlying such growth include population
growth, increased life expectancy, growing quadruple disease burden and increased domestic
healthcare spend due to the introduction of the NHI.
South Africas spend on medical devices per capita is US$24, which is comparable to fellow
BRICS countries. However, when comparing to more mature markets such as the United States
and Germany, where per capita spends stands at US$399 and US$313 per capita respectively, it
suggests that there is ample room for growth.
At present medical device imports make up 90% of the total medical device market. Analysis of
international trade flows of medical devices shows that the gap between imports and exports has
widened between 2004 and 2013.
Main Competitors
Around 90 percent of medical equipment is imported with the U.S. playing a dominant role
(27 percent), followed by Germany at 13.7 percent. However, imports from China have doubled
over the last five years to 8.4 percent. Other notable countries include Switzerland, Japan, UK,
and France. Countries like Mexico and Singapore have also increased their supply to
South Africa.
Many suppliers in South Africa are subsidiaries of overseas corporations. The major U.S.
medical companies represented in South Africa (either through local representatives or
subsidiary offices) include 3M, Advanced Orthopedics, BSN Medical, BARD, Beckman Coulter,
GE Health, Johnson & Johnson, Abbott Labs, Alcon, Medtronic, and many more. U.S.
companies new to this market may experience strong competition from U.S. firms or
multinationals already established.
Current Demand
Medium-term prospects for the medical device industry look promising. The market is expected
to grow at a compound annual growth rate of 8.7 percent from 2012 through 2017.
The market is extremely price-sensitive. The sophisticated South African medical community is
generally interested in new technology developments and products. The South African
government is also revamping public hospitals and building new clinics as part of their campaign
to introduce and develop national health insurance (NHI).
IMPORT REGULATIONS
Importing in South Africa can be rather intimidating with all the rules and regulations that need
to be compiled with.
Whether you have been importing and exporting for a while, or are looking at starting a new
venture, there are a few important things that you need to know. Well start with the basics.
Registering
The first thing that needs to be established when importing into South Africa is whether you are
VAT registered. It is highly recommended that you be VAT registered as you can claim the VAT
back as a normal trader. You will also need an importers code. You can get this by completing
the DA 185 as well as the DA185.4A1 form with SARS. The documents can be downloaded
from their website: www.sars.gov.za
Timeframe: Import Export and VAT registration takes 7 to 30 working days.
Cost: No cost to register if done in person Facilitation Companies charge R3,200 to complete
the process
Labels on Imported Products
Labels on imported products must be printed in English. The law requires that the information
and ingredients must appear in one or more of the official languages. The SABS publish a book
which can be obtained directly from them which includes all the regulations that must be adhered
to with regard to labelling. You can order it online or it can be posted to you.
Decide on a shipping method
The next step when importing is deciding how to ship to South Africa. There are various
shipping methods, namely sea freight, air freight, road freight and rail freight. Sea and air freight
are the most common shipping methods when importing into South Africa. Rail freight is often
used to transport goods around the country, e.g. to Durban or Johannesburg, as well as containers
delivered to the depot. When deciding on a shipping method, the most important factor that
comes into play is the time line and the cost. Sea freight from Europe takes around 6 weeks to
South Africa and from the Far East around 5 weeks to South Africa. Air Freight takes around 1
week due to clearance, consol flights and customs clearance in South Africa.
Import and export procedures
Import and export control is the function of the International Trade Administration Commission
of South Africa (ITAC).
Import permits
Most goods may be imported into South Africa without restriction. However, the importation of
certain goods specified by government notice is only permitted subject to the issuance of an
import permit. All second-hand goods, including waste and scrap of whatever nature, require an
import permit. For goods subject to restriction, importers must be in possession of the required
permit before the goods are shipped.
ITAC controls the issuing of permits. Additional and prior authorization may be required from
other departments with jurisdiction over the control of the goods in question. The permit can be
acquired within three days, depending on the nature of the application.
For a complete list of goods currently subject to import control, an importer should approach the
ITAC. There is no fee applicable. Permits are valid for 12 months from date of issue.
Applications should be filed at least two weeks prior to the date of shipment in order to ensure
approval in time for shipment.
Once you have registered as an importer to South Africa, you need to determine the costs
involved. This is where your shipping method and Incoterm decisions come into play.
There are various shipping methods, such as Sea freight, Air freight, Road freight and Rail
freight, and each has its own costs and timeline factors. The most common forms of shipping
methods are Sea and Air freight.
Sea Freight
Sea freight is the most economic form of transportation when using the containers capacity
efficiently.
Transit times to South Africa need to be considered with this shipping method. When shipping an
LCL (Less than Container Load) it usually takes longer than a FCL (Full Container Load).
Transhipments also often occur when containers are transferred onto another ship along the
route, versus direct sailing. An important term to become familiar with is Twenty-foot equivalent
units. This is how container capacity is measured. TEU = 6m container. 1 X 40 FCL = 2 TEUs.
Container and seal numbers are used to identify your cargo, and this information is usually given
on the bill of lading. A seal is used to ensure that the container is not opened from the suppliers
warehouse until delivery to your premises or chosen address, and is also used to identify the
shipping line. The only time of opening is for a customs inspection.
There are various container types and sizes, but the most common containers are:
Standard containers These are widely used dry / general purpose containers and are
found in 20 and 40 sizes.
High Cubes In South Africa, these are usually 40 containers that are taller than the
standard containers.
Reefer containers This refers to refrigerated containers that are often used for fresh
produce and temperature controlled items.
This is a popular way to ship and the reason for the increase in air freights is the growing volume
of technology-based products which are becoming lighter, with greater value. This justifies the
expense of air freight.
There is also an increasing trend towards Just-in-time (JIT) inventories, hence the use of air
freight in order to make this possible. Most air freight shipments are done on an Ex Works basis.
The loading and stowing of cargo is done by the airline details of dimensions and weight is
provided to the airline on booking to ensure space and packing configurations. Some airlines
have height restrictions and your service provider can provide you with these details.
Consolidation is usually done by your forwarder to ship it via air at a discounted or cheaper rate.
Charges involved with Air Freight
Pick up charges, Clearance charges, Air freight, Fuel surcharge, Security surcharge, Local
charges, Clearance, Cartage, Airline handling Fee and Airline split fee. The airlines split fee is
charged per parcel.
Air freight calculations: Airlines that are members of the International Air Transport
Association (IATA) are bound by their membership to comply with tariffs issued by IATA.
However since 11th September 2002, airfreight rates are now extremely negotiable. Airfreight
rates cover transportation from the airport of loading to the airport of discharge in South Africa.
THESE RATES DO NOT INCLUDE THE FOLLOWING:
There is a basic minimum charge per shipment. The minimum is usually 45 kgs.
The general cargo rates that are quoted for are per kilogram. This rate applies without
reference to the nature or description of the parcel which is to be freighted.
Specific commodity rates apply to certain goods of specific descriptions, such as fresh
produce. Rates will be different for each variation of cargo and is usually on a sliding
scale, your service provider will be able to give more accurate details.
Inland Transport: A common mistake is to pay no attention as to how your goods will arrive at
your warehouse / property / door. Inland transport costs are by no means included in you freight
costs. Collections from the port are not only ill advised but in most cases not permitted - some of
the reasons are as follows:
Importing documents
We suggest that you have all the required documentation before submitting to your clearing
agent to ensure that it all goes smoothly. We also recommend having literature (which are
pictures, descriptions and compositions of the items) to ensure that any query with South African
customs is resolved quickly. Being prepared means no unnecessary additional costs.
Your customs documentation must be kept for a 5 year period as customs can at any time do an
audit on your South African imports to ensure the correct import tariff headings were used. We
suggest that you ensure that you give your service providers / clearing agents the required
documentation within 10 days of shipping to South Africa to ensure that it is pre-cleared by
customs before arrival and if there are any queries by customs this can be resolved before arrival
into South Africa so as to avoid any unnecessary storage charges.
Customs clearance procedures
The clearance of imported goods generally takes a maximum of 24 hours for airfreight and two
to three days for sea freight, depending on the port of entry. All required documentation must be
submitted to Customs and Excise before goods can be cleared through Customs.
Most transactions are covered by a Bill of Entry (Form SAD500).
Other required documentation includes:
Commercial invoice.
Prescribed certificate of origin when preferential duty rates are claimed.
Negotiable copy of bill of lading or equivalent document.
Import permit, if required.
Rebate permit 470.03 (if applicable) for raw materials to be processed and re-exported.
Payment, by a bank guaranteed check, for all applicable duties and taxes (incl. VAT), if not
qualified for a deferment.
Import shipments may be cleared through Customs prior to the goods arriving at a South African
port. As of January 2012, foreign persons who are not registered or do not have a physical
address in SA have been required to appoint a registered agent, who is located in SA, when
applying to register with the South African Customs authorities as an importer, exporter or
licensed remover.
In order to avoid unnecessary delays, HSI or its appointed SA agent may wish to submit an
application for a tariff determination for products where the tariff heading is unknown or under
dispute. These can be acquired from the Commissioner in Pretoria (submitted through the
relevant branch office).
In the case of sea freight, once customs has been cleared, the importer must pay dues to Harbor
Revenue, and receive a wharfage order. The importer then pays the operator and receives a
release. At this point, the importer can go to the terminal and collect his goods. Sexy Pandas
International strongly recommends HSI use a freight forwarder as a registered import agent. One
key reason for this is that the import process has become a fully automated process since July
2009. SARS enforces the use of Electronic Data Interchange systems (EDI) for the submission of
medical devices import declarations and reports and small importer dont typically have the
infrastructure to use EDI.
Since the Customs process is paperless, clearing Customs is simpler. Straight-forward
commercial entries pose little problem. Problems may arise when you deal with an individual
Customs officer, as no two will interpret a situation the same. An effort is made to limit contact
with Customs officers, to minimize potential deceptive practices. As with most government
departments, bureaucracy prevails and nothing is ever simple. There is not much difference
between Air and Sea shipments when dealing with customs.
Freight forwarders commonly apply for all licenses and registration numbers. They can apply for
tariff determinations and provide assistance in properly classifying goods. Through the use of
technology, they can clear goods quicker than an individual investor, and provide inland
transport for the goods to reach the investor. Freight forwarders can also assist in accurately
costing a product. They are able to give a pre-shipment landed cost per item, that will enable HSI
to make better and more informed buying decisions. The minimum information required for an
estimate is the item, unit price, quantity, volume or weight, product description, incoterm,
expected port of loading and final destination. HSI can then make buying decisions based on the
estimate of the total landed cost. For more information, contact the South African Association of
Freight Forwarders (SAAFF) for more advice with regard to clearing agents. Call +27 11 455
1726, email: saaff@saaff.org.za or visit www.saaff.org.za/contact/default.aspx
Deferment of payment scheme
A deferment scheme is available to qualified importers that allow the deferment of applicable
import duties, and VAT. Payment is generally deferred for 30 days with seven days to settle the
account. No locally manufactured goods, (duties and levies) may be deferred under this scheme.
To apply for deferment, importers may apply to the local Customs Controller.
Required documentation includes:
Application for deferment.
Statement of income.
Balance sheet.
The local controller will make its recommendation to the Commissioner. Following approval, the
applicant will be required to submit additional documentation, including a signed agreement and
any required surety bond.
Duty drawback scheme
A duty drawback scheme provides refunds for import duties paid on materials used in the
production of goods exported. Manufacturers may apply for refunds after the final product is
exported. Manufacturers must provide proper documentation to reconcile imported materials
with exports.
Bonded warehouses
Secure bonded warehouse facilities are available at all points of entry and may be used to store
imported goods without payment of duties until required for use, resale, or re-export.
Goods withdrawn from a bonded warehouse are liable for the duty applicable only if cleared out
of bond for home consumption. Goods may be stored for no more than two years. However, the
new customs legislation proposed a reduced storage period of 12 months only (i.e. one year).
You can contact South African customs in Cape Town for more information by calling +27 21
413 6733
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DISTRIBUTION CHANNELS
One of the first steps that an exporter may wish to take in locating an agent or distributor in
South Africa is to contact the U.S. Commercial Service in South Africa and register for one of
the services specifically designed to meet the needs of U.S. client companies. South Africa offers
foreign suppliers a wide variety of methods to distribute and sell their products, including using
an agent (also known as a Commission Sales Representative, or CSR) or distributor.
In South Africa, the terms Agent and Distributor have a very specific meaning: agents
work on a commission basis after obtaining orders from customers; distributors buy, carry stock
and sell products directly to customers.
Agents often distribute durable and non-durable consumer goods, as well as some industrial raw
materials. They may be particularly appropriate when products are highly competitive and lack a
large market. It is common to appoint a single agent capable of providing national coverage
either through one office or a network of branch offices. In addition to their role as the local
representatives of US exporters, agents should be able to handle the necessary customs
clearances, port and rail charges, documentation, warehousing, and financing arrangements.
Local agents representing foreign companies who export goods to South Africa, are fully liable,
under South African import law, for all regulations and controls which are imposed on the
foreign exporters. Local agents are required to register with the Director of Import and Export
Control of the Department of Trade and Industry. It is important for a US exporter to maintain
close contact with the local agent to track changes in importing procedures and to ensure that the
agent is effectively representing the sales interest of the exporter.
Typical commission rates for agents depend upon the contract concluded and upon the
representatives responsibility. These rates can range from 3 to 25 percent commission per
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concluded transaction. Companies sometimes pay a retainer fee plus costs plus an incentive scale
on deals.
Distributors who buy for their ow account and carry a wide range of spare parts often handle
capital equipment and commodities such as chemicals, pharmaceuticals, and brand new products
on an exclusive basis. Leading distributors often have branches throughout South Africa and sell
to both wholesalers and retailers. In some cases, the distributor is also the principal with subagents or as a major user of the products.
When appointing a South African distributor, US exporters should take care to find out if the
distributor handles a competing product. In some instances, major South African corporations
whose holding companies market products competing directly with American products have
approached some US exporters.
In South Africas competitive marketplace, it is essential that he US exporter provide adequate
servicing, spare parts, and components, as well as qualified personnel capable of handling
service inquiries. In most cases, after-sales service should be available locally since potential
delays often lead purchasers to seek alternative suppliers.
The US commercial service has found that the most successful ventures entered into by US
companies have been preceded by thorough market research. This is an important first step
before engaging in a search for agents or distributors. Once contacts are established, US
companies should visit South Africa since first-hand knowledge of the market and society is an
advantage. Such a visit provides an opportunity for a personal appraisal of the prospective agent
or distributor. US exporters should carefully investigate the reputation and financial references of
a potential agent or distributor and establish a clear agreement delineating the responsibilities of
both the exporter and the agent.
The Africa Health trade show is a good entry point and any new entrant into the South African
market should plan to attend. Africa Health is the continents largest healthcare exhibition and is
the leading platform for the industry to meet, learn and do business. The next edition of the
exhibition will take place 8 -10 June 2016 at the Gallagher Centre, Johannesburg. The exhibition
is expected to attract more than 7000 healthcare professionals and host 500 of the worlds
leading healthcare suppliers, manufacturers and service providers including medical device
agents & distributors.
In addition, the US commercial service in South Africa offers a number of business facilitation
services, including market research, appointment-setting, and background checks on potential
service partners.
Typically, distribution is done through local agents and distributors. In South Africa, there is a
distinction between an agent and a distributor. The agent orders the product on ad-hoc basis and
generally works on a commission basis. The distributor will usually have a larger stocking
capacity and enters into a formal agreement with the manufacturer. Some will only carry a
specific brand name and become a subsidiary, e.g. Bayer (Pty) Ltd South Africa. Others may
carry a string of non-competing products from different manufacturers. Most potential
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distributors with a national sales territory will prefer to have exclusive arrangements with the
original manufacturer. It is important to ensure that local distributors have maintenance and
after-sales repair capabilities, and train staff regularly.
Please note that the South African standard for electrical voltage is 220 volts, as opposed to the
US standard of 110.
A judicious selection of one of three low-risk entry strategies (representation, agency, or
distributorship) is required by new-to-market entities. If you are selling to the government or to
government-funded organizations, any local partner should be B-BBEE compliant and be aware
of local procurement regulations.
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have training, maintenance, and after-sales repair capabilities. HSI should also ensure that the
chosen distributor does not himself manufacture or carry competing products from different
manufacturers. Based on all these criteria, Sexy Pandas recommends Stat - Tiakeni Medical as
HSIs distributor.
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compliance with ISPM 15 and should any infestation be found it will be treated on expense of
the importer or re-exported to the exporting country or disposed of in a manner determined by
the National Plant Protection Organization of South Africa (NPPO) as published by Department
of Agriculture
Terminal Charges
ISPS - Terminal Security
Surcharge
Terminal Handling Charge Reefer Container
Terminal Handling Charge Hazardous Container
Terminal Handling Charge Out of Gauge Container
Terminal Handling Charge Empty Container
Terminal Handling Charge Dry Container
Terminal Handling Charge Hazardous Reefer Container
20'
USD 13.00
40'
USD 13.00
ZAR 2097.00
ZAR 3112.00
ZAR 2052.00
ZAR 3050.00
ZAR 2052.00
ZAR 3050.00
ZAR 1312.00
ZAR 1939.00
ZAR 1471.00
ZAR 2172.00
ZAR 2678.00
ZAR 3990.00
Storage Charges
20'
FIRST DAY
Dry Van
ZAR 2048.00
Reefer
ZAR 3050.00
Out of Gauge
ZAR 3050.00
Hazardous Cargo
ZAR 2560.00
Shipper Owned Container
ZAR 1950.00
THEREAFTER
Dry Van
ZAR 490.00
Reefer
ZAR 2190.00
Out of Gauge
ZAR 2150.00
Hazardous Cargo
ZAR 560.00
Shipper Owned Container
ZAR 250.00
Container Rent (Demurrage and Detention)
Effective from April 1, 2015 until March 31, 2016
40'
ZAR 3478.00
ZAR 5443.00
ZAR 5443.00
ZAR 4346.00
ZAR 3200.00
ZAR 970.00
ZAR 3650.00
ZAR 3600.00
ZAR 1120.00
ZAR 500.00
Demurrage starts after all vessel discharge / Demurrage starts on day after discharge / exclude
from free days, public holidays are included.
Applies to: While in port and with customer
Container Size
Free Days
1st Period
Type
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1st Rate
Thereafter Rate
20DV
40DV
40HC
20SP
40SP
20RE
40RE
40HR
5 Calendar Days
5 Calendar Days
5 Calendar Days
5 Calendar Days
5 Calendar Days
4 Working Days
4 Working Days
4 Working Days
10 Days
10 Days
10 Days
10 Days
10 Days
10 Days
10 Days
10 Days
USD 38.00
USD 76.00
USD 76.00
USD 70.00
USD 140.00
USD 70.00
USD 140.00
USD 140.00
USD 60.00
USD 120.00
USD 120.00
USD 120.00
USD 240.00
USD 120.00
USD 240.00
USD 240.00
REFERENCES
South Africa Regulations, 03/07/14, CMA-CGM, DELMAS
GRAEBEL country profile: South Africa
http://www.doingbusiness.org/data/exploreeconomies/south-africa/#trading-across-borders
http://tradelogistics.co.za/customs/
http://www.entrepreneurmag.co.za/ask-entrepreneur/import-export-ask-entrepreneur/im-startingan-importing-business-what-are-the-importing-terms-and-documents-involved/
http://www.joskezfreight.co.za/index.php/sars-news
Deloittes Research to guide the development of strategy for the Medical Devices Sector of
South Africa
Wesgro Cape Town and Western Cape Research Document on Medical Devices Sector from
http://wesgro.co.za/publications
South Africas Medicine Control Council (MCC) General Guideline Medical Device IVD Aug14
v1 for comment.docx Sept 2014
Doing Business in South Africa - 2015 Country Commercial Guide for U.S. Companies
Linkedin.com
Import customs procedures in South Africa from https://en.santandertrade.com/internationalshipments/south-africa/customs-procedures?
&actualiser_id_banque=oui&id_banque=18&memoriser_choix=memoriser
LEX Mundi Publication on Medical Devices SOUTH AFRICA by Bowman Gilfillan, 2011
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