Group Members

Muhammad Ahmed 2019285

Surgical
Omar Farooq 2019523
Equipment
Muhammad Idrees 2019336
Ahmad Jan 2019048
Abdullah Inayat 2019015
Mind Map
 Why Export Surgical Equipment
Global market

Pakistan is renowned for surgical equipment export

Surgical equipment are value added products

Unexplored export potential

High profit margin

Expertise
Introduction
• A surgical instrument is a tool or device for performing specific actions or carrying out desired effects
during a surgery or operation
• There are a wide array of instruments available for use during a surgical procedure, each with
their specific uses and advantages (and disadvantages).
• As a surgeon, it is important to know not only their names but when they should be used, and
each specialty will have their own specific kit.
Variety of surgical
instruments
There are several classes of surgical instruments:
• Graspers
• Clamps
• Surgical scissors
• Needles/Sutures
• Distractors etc.
Export Potential HS4 ID9018
Trade Value$432M
Year2019
Pakistan
World Market
Share of
Surgical
Equipment's
Where does Pakistan Export Medical Instruments to
Growth%
Three countries selected for our product exporting

• RUSSIA
• CHINA
• INDONESIA
Relations with
TURKEY

• Under the PTA, Pakistan has market

access in 261 tariff lines
• Pakistan’s global export of these
products is $5.1 billion
• The total trade between Pakistan
and Turkey stood at $883 million in
the fiscal year 2021-22
• Pakistan’s exports to Turkey
amounting to $366 million
•  
Export with Turkey
Pakistan Exports of instruments and appliances used in medical, surgical, dental/veterinary to Turkey was US$5.02 Million during 2021
Bilateral Relations
with China

 China and Pakistan have witnessed smooth

development of friendly and neighborly
relations as well as mutually beneficial
cooperation.

 One Belt, One road initiative have brought two

countries closer.

  Pakistan and China's bilateral trade volume

grew to some $15.6 billion in the 2019 fiscal
year.

 In 2020, Pakistan exports to China grew to $2

billion
 EXPORT WITH CHINA
Pakistan Exports to China was US$3.03 Billion during 2021
Pakistan relations
with France
• The relationships are based on
military, defence, cultural,
educational cooperation and
economic ties
• Pakistan Exports to France
was US$453.4 Million during
2021
• France accounted for 5% of total
EU imports from Pakistan in 2016
• Trade between the two countries
is generally increasing with time
 Exports with France
Pakistan Exports of instruments and appliances used in medical, surgical, dental/veterinary to France was US$11.06 Million during 2021
 • Turkey is a muslim country and have good
relations with Pakistan
• Pakistan has the potential to export $5
billion to Turkey, with the greatest
Socio- potential ($329 million) in the product
“Instruments and appliances used in
political medical/surgical/veterinary sciences”
• Turkey and Pakistan are founding members
feasibility of the Economic Cooperation Organization
 and part of the Developing 8 Countries (D-

with Turkey 8) organization

• Pakistan Exports of instruments and
appliances used in medical, surgical,
dental/veterinary to Turkey was US$5.02
Million during 2021
 • Pakistan was one of the first countries that
recognized the People's Republic of China
Socio- • Pakistan Exports to China was US$3.03
Billion during 2021
political • Pakistan's exports to China have reached an

feasibility 11% increase in the first half of 2022

• the China-Pakistan Economic Corridor
with China (CPEC) is being considered as a game
changer
 • France and Pakistan have enjoyed amicable
relationships since the 1960s
• Pakistani exports to France have increased at an

Socio- annual rate of 2.2 per cent, from USD 371

million in 1995 to USD 639 million in 2020

political • Pakistan also needs France’s support in the FATF

case

feasibility • Pakistan's exports to France are dominated by

textiles, followed by rice, leather and surgical

with France instruments

• Pakistan Exports of instruments and appliances
used in medical, surgical, dental/veterinary to
France was US$11.06 Million during 2021
 Amazon

Platforms Ali Express

Direct
Global
Events
 • In order to list in health and personal category, sellers need to get approval from
Amazon first.
• The maximum number of inventories hold by the amazon is 200 units initially. The
inventory size may increase if the demand increases.
PROCEDURE:
1) We choose to send our inventory to the New York warehouse of amazon.
2) We will hire a trading company to send our inventory.
3) We will choose the sea method which is cost effective, and we will send our
inventory based on the forecasting of the product.
4) Equipment's are individually packed into a box of a specific dimension and a bar

Amazon code is generated for each box. The bar code and address are pasted on each box.
5) Specific number of individual boxes are packed into a master carton.
6) A bar code is pasted on the master carton which is generated by amazon and is
unique.
7) These boxes are exported through the trading company .
8) Trading company includes the cost i.e., delivery duty paid which includes the taxes
and the export duty and the clearances.
9) When the product reaches the amazon center it takes around one week for the
item to get live i.e., the barcode verification and other legal procedures.
10) If we want our product to be placed at various inventories, then there are two
ways. The first one is that the Amazon itself gives service to place our product in
various warehouses which is a paid service. The second method is that we
ourselves send the product to different warehouses if it is more economical. We
chose based on cost-effective way.
 • Owners or operators of facilities that are involved in the
production and distribution of medical devices intended for
use in the U.S. must be registered with the FDA

Registration,
• Medical devices must not have been the subject of any
unresolved FDA enforcement such as FDA warning letters.

Clearance,
• Medical devices must be cleared by the FDA for sale in
the U.S

and
• CE Certificate is required for products manufactured
anywhere in the world that are then marketed in the EU

Approval
• MDL & MDEL Certificates are required to export in
Canada
• Medical masks sold to Japan require PSE certification
• Medical masks sold to South Korea require KC
certification
Labelling
• All medical devices must be labeled in English and the
receiving country’s national language with the
following information:

1. The name and place of business of manufacturer,

packer, or distributor, including the street address,
city, state, and zip code;
2. Directions for use, including:
Statements of all purposes for which and
conditions under which the device can be used
3. Frequency of administration
4. Duration of application
5. Time of administration in relation to other factors
6. Route or method of application
7. Any preparation necessary for use.
 • The requirements below apply to all product
marketing materials, including the product detail
page, product packaging, and any instructional
materials or package inserts included with the
product.
Marketing 1.Medical devices must not make false or
misleading statements.
2.Medical devices must use the claims 'FDA
cleared' or ‘FDA approved’ appropriately.
3.Medical devices must not use the FDA logo.
 • The AliExpress marketplace accepts both
sellers who are companies and those that
are sole traders. Your company must be
registered, and you will need to provide
legal, tax and personal documentation
• The main step is to upload your product
information to the marketplace.

AliExpress • No limits on number of products

published.
• Access to sales throughout Europe.
• Connectors enable you to integrate your
inventory with AliExpress from other
marketplaces, such as Amazon and eBay.
 Post the products
Make account with
that you are likely to
Aliexpress.
sell.

Procedure Create a storefront Reply to inquiries

Protect order and

Optimize your sales
payments
 • Medical devices must be cleared by the
FDA for sale in the U.S
• CE Certificate is required for products
manufactured anywhere in the world that
are then marketed in the EU
Legal • MDL & MDEL Certificates are required to
export in Canada
Requirements • Medical products sold to Japan require
PSE certification
• Medical products sold to South Korea
require KC certification
 Medical devices must be labeled in both the receiving
country’s regional language and English. Labeling
requirements include but are not limited to:
•name of the device;
•name and address of the manufacturer;
•identifier of the device;
•indication of what the package contains if the item
inside is not self-evident, expressed in terms
appropriate to the device, such as the size, net weight,
length, volume or number of units;
Labelling •the word "Sterile", if the manufacturer intends the
device to be sold in a sterile condition;
•expiry date of the device;
•special storage conditions applicable to the device.
•Do not use if seal is broken.
 • Exhibitions/Expos
• Represent Pakistan
• Meet and Connect with Potential Clients.
Direct • Increase Your Brand Awareness.
Global • Gain More Knowledge of Your Industry.
• Benefit from Cost-Effective Marketing.
Events • Close Deals.
• You Learn What Works and What
Doesn't.
• Launch a New Product.
 Legal Requirements
1. Company registration and certification
2. NTN (National Tax Number)
3. Bank Account
4. Sales Tax Registration
Export 5. Chamber Certificate

Process 6. Commercial Invoice

7. Packing List
8. Certificate of Origin
9. Letter of Credit (L/C)
10. Form E
FINANCIAL
REQUIREMENTS:

Shipping Cost
Labor Cost
Utilities Cost
Rental Payments
Miscellaneous Cost
Maintenance
Labor Training, Safety Equipment's Cost
Holding Cost
Raw Materials Cost
30% Profits
Defective/Rejected
INVENTORY
• It will be a perpetual inventory-based system.
• There will be barcode scanners at every
station of the manufacturing/assembly line.
• The scanner will scan and report the current
progress and station of each item.
• Lot number, product code name along with
details like color, material, brand, year etc.
• The products stored would again be scanned
automatically by an automated barcode
reader and the products will be checked out
of the warehouse to the 3PL, 4PL partner
and/or to direct customers etc.
 Exports
Logistics
Process
Tax Structure
• Income Tax
• Export Development Fund (EDF)
• Sales Tax
• Rebate
Income Tax
• 95% of the total production is exported so the industry is exempt from income tax.
• Surgical instruments fall in the high value-added segment
• Exporters, according to the Eighth Schedule of the income tax ordinance, pay only a token tax at
the rate of 0.50%.
• The range of the token income tax varies from 0.50% to 1.00% depending on the level of value
addition in the products.
• Exporters are liable to pay minimum of percentage of their income as tax
 • The export development fund contribution is
made by every exporter at the rate of 0.25% of
the total value of goods exported.
• This fund is collected with the purpose of further
developing the exports from Pakistan.
Export • Resources from this fund are utilized for
Development subsidizing export trade fairs, establishing
technical centers for research and development,
Fund training seminars, and on several other projects
and activities focusing on the development of
exports-oriented industries.
• Currently the fund is being managed by the
Export Promotion Bureau.
 • Sales tax has been levied on all the sectors at
the rate of 17%.
• All the imported goods are also subject to
sales tax at the same rate. The raw materials,
stainless steel, grinding belts and wheels, etc
are all imported by the manufacturers who
have to pay sales tax on the imported goods.
Sales Tax • This sales tax in case the materials are used
to produce exportable products is refunded
after the consignment has been shipped.
• The exporter in the concerned collectorate
submits the sales tax refund, which after
evaluation and assessment refund the sales
tax amount.
Rebate
• Rebate, in other words duty drawback, is the amount that is reimbursed by the government to
the exporter as compensation for the duty paid by him on imported components used in
manufacturing a product.
• The rate of rebate, to be paid on different products, is determined by the Ministry of Production
and Industries.
• Ministry calculates the number of imported inputs used to manufacture a particular product and
then fixes the rate of duty drawback.
• The rebate is paid by the government as a percentage of the FOB value of exports.
• For surgical instruments, currently the rate of duty drawback has been fixed at 7.11% of FOB
value.
Operational feasibility

• Is the project feasible within the limits of current technology?

o Yes, industries for surgical equipment already exist in Pakistan.
• Is it available within given resource constraints?
o Yes ,the raw materials are locally produced and are readily available.
• Is it a practical proposition?
o We have enough capital to start and sustain it for around 5 years.
• Are the current technical resources sufficient for the new system?
o Yes, the machinery required can be bought locally.
• Can they be upgraded to provide to provide the level of technology necessary for the new system?
o If we are making enough profits then we will think about upgrading and expanding.
• Do we possess the necessary technical expertise, and is the schedule reasonable?
o We already have enough expertise and the schedule is also flexible.
What Is FDA Approval?

• FDA approval means that the FDA has formally approved your product (in
this case, your medical device). This is important to establish that your
device is safe and effective.
• But to get FDA approval, you’ll need to prove compliance.
And What Is FDA Compliance?

• FDA compliance means following product safety regulations set by the FDA.
You’ll need to prove compliance in order to get your device out to market.
How Much Does it Cost to Get a 510(K) Approval?

The overall cost to get FDA approval for a 510(K) notification ranges
between $30,000 and $44,000 USD. This includes the preparation of
the submission and all associated FDA costs. The major influencing
factors to the final cost are:
1) the cost required to prepare the submission
2) the qualification of the company as a small business.
Submit • To get FDA clearance to market and distribute your class II or class III device, you’ll need
to submit a pre-market notification or application.

Your •
•
As part of this, you’ll need FDA verification and validation of your device.
FDA Verification

Application
• FDA verification is important for making sure the requirements you set are fulfilled. You
should be able to answer the question…
• Are you designing the device right?

s •
•
You can answer yes if:
Requirements are implemented.
• Requirements are verified.
• Requirements of standards are met.
• FDA Validation
• FDA validation is important for making sure the device you deliver fulfills the needs of the
market. You should be able to answer the question…
• Are you designing the right device?
• You can answer yes if your device meets the needs of:
• Device users.
• Stakeholders within your company.
• Regulatory stakeholders.
Wait for
FDA
Review
and
Approval
The next step is to wait for the FDA to review and approve
your device.
Maintain FDA Compliance

• You’re not in the clear once you’ve received FDA approval. You’ll need to ensure your device stays in
compliance for its lifespan.
 Means of • By Air
• By Sea
Transportation • By Road
 • By Sea

• There are different shipping lines that

transport Surgical instruments from
Pakistan
• MSC, IPL, APL and Wanhi.
• They transport from port to port.
• At, first clearing agents clear the
container from customs which the be
shifted to shipping lines.
By air

 Mostly, Surgical equipments is

exported by sea.
 In small orders, which should be
less than 10 tons can be
exported by air.
 But, by sea is the cheap mode of
transport.
By Road

• Only Neighboring countries

(China)

• Complication
• Freezing Problem
 • Effective inventory management.
• Use efficient methods of forecasting.
• Improve customer service and service quality.

Lean Supply • Increase automation in production and storage.

Chain • Emphasis on implementing a greener supply chain.

• Prioritizing quantity discounts.
• Keeping a smaller supply base.
 Core Business
Processes Surgical
Equipment
 •https://oec.world/en/profile/country/pak
•
https://tdap.gov.pk/wp-content/uploads/2020
/11/1-Step-by-Step-Guide-for-Exporters-Export
References -Procedures.pdf
•https://geniusimpex.org/import-export-docu
ments/
•https://sellercentral.amazon.com/gp/help/ext
ernal/200164650
Thank You