2017.10.18 MDMA Webcast

BEST STRATEGIES TO SUCCEED IN
ASIA
MDMA Webcast: October 18, 2017

Presented by Ames Gross, President
Pacific Bridge Medical
7315 Wisconsin Avenue, Suite 609E, Bethesda, MD 20814
www.pacificbridgemedical.com
Copyright © 2017 Pacific Bridge Medical. All rights reserved. This content is protected by US and International copyright laws and may not be
copied, reprinted, published, translated, resold, hosted, or otherwise distributed by any means without explicit permission. Disclaimer: the
information contained in this report is the opinion of Pacific Bridge Medical, a subsidiary of Pacific Bridge, Inc. It is provided for general
information purposes only, and does not constitute professional advice. We believe the contents to be true and accurate at the date of writing
but can give no assurances or warranties regarding the accuracy, currency, or applicability of any of the contents in relation to specific situations
and particular circumstances.
1 Copyright © 2017 Pacific Bridge Medical | www.pacificbridgemedical.com

INTRODUCTION TO PBM
PACIFIC BRIDGE MEDICAL (PBM) is a leading medical consulting firm dedicated to

assisting medical companies in Asia. Our consultants have helped over 500 medical
companies with business development, regulatory affairs, sales, sourcing, and market
research in Asia since our founding in 1988. We are very knowledgeable about the
Asian healthcare market and have a great team on the ground in each Asian
country with various medical expertise.
Overview of Asia

Asia Economic Statistics (2016)
Per capita GDP Real GDP (PPP)
Per capita GDP growth GDP (PPP) Growth Rate
China $8,000 6.4% $21.3 trillion 6.7%

Hong Kong $42,330 1.5% $427 billion 1.9%
India $1,590 6.6% $8.7 trillion 6.8%
Indonesia $3,350 3.5% $3 trillion 5%
Japan $34,530 1.4% $4.9 trillion 1%
South Korea $27,220 2.2% $1.9 trillion 2.8%
Malaysia $9,770 3.5% $863 billion 4.2%
Philippines $2,900 4.3% $801 billion 6.8%
Singapore $52,890 0.8% $486 billion 2%
Taiwan $22,450 2% $1.1 trillion 1.4%
Thailand $5,810 2.5% $1.2 trillion 3.2%
Vietnam $2,110 5.5% $594 billion 6.4%
United States $56,120 1.8% $ 18.6 trillion 1.6%
European Union $32,020 1.9% $19.2 trillion 2%
Source: World Bank and other PBM sources

Size of Medical Device Markets (2016)
Global Medical Device Markets
Region Market Size (US$) Growth
Asian Medical Device Markets
U.S. $140 billion Country 3% Size (US$)
Market
EU $130 billion 2%
China $22 billion
Japan $27 billion 1.5%
Hong Kong $850 million
Asia Pacific $34 billion 20%
India $3.5 billion
Latin America $12 billion 8%
Indonesia $780 million
Latin America
Global Medical Device Markets Korea $3.9 billion
3%
Asia Pacific Malaysia $1 billion
10%
Philippines $300 million
Japan Singapore $530 million
8% U.S.
41% Taiwan $2.5 billion
Thailand $850 million
Vietnam $630 million
EU
38%

Asian Medical Device Market Trends

Asian Medical Device Market Trends
• Explosive demand for medical devices in the Asian markets
attracts Western and local medical device companies.
• Western medical device companies’ increasing sales to Asia
with basic models and lower costs of their top of the line
Western products.
• Western device companies are sourcing/manufacturing in
Asia more.
• Many more local Asian medical device manufacturers now
in business making more sophisticated products with
components of better quality as demand increases in the
region and globally. More Asian device manufacturers
compete with West.

Which Asian Markets Should You Go to
First/Last?
•Is it a high technology device?
•Is the device very expensive?
•Can the device be easily reverse engineered?
•Which countries in Asia have the best
healthcare systems?
•Which strategies should I use?
–Distributor network, joint venture, subsidiary

China: Medical Device Market
•China remains one of the most
compelling markets for medical
devices companies globally. The twin
effects of an ageing population and a
burgeoning, upwardly mobile urban
middle class are placing strain on the
country’s public hospital system, which
is pushing up demand for new
products and services
China: Key Market Research Issues
• Research has to be well thought out
• Secondary research – not normally that accurate;
government statistics not reliable or non-existent
• Primary research is the best way to go
• Researcher should have worked for Western medical
companies before
• Big research companies send out 20 year olds, may not
have experience to get answers you need; maybe a few in-
person quality interviews will do
• Determine if there is a market before product registration;
many companies do not do this

China Distributor Search
•US medtech company (about $200 million in
sales) sells product to Chinese importer
•Chinese importer buys about $3 million per year
from US medtech company
•Re-register similar products
•Undercover find out copycat manufacturer owns
Chinese importer
•Copying NOT illegal in China if no patent, exact
same copy
Chinese Medical Device New Regulations
(October 1, 2014)
• 2000 Regulations only 6 chapters and 48 articles.
Now 2014 Regulations 8 chapters and 80 articles
• Class 1 – Notification, not registration, but more
documentation needed than previous class 1
registration
• Class 2/3 devices – more local clinical trials needed
• Class 3 device clinical trials require CFDA protocol
approval
• Registrations now good for 5 years not 4
• More information required on outside labels in
Chinese
• Advertising restrictions
Chinese Medical Device Registration
• Getting a lot tougher and longer for approvals (new
regulations October 2014)
• New standards released
• Testing delays (only 10 centers)
• More supplementary reviews requested by the
CFDA
• Will clinical evaluation reports work?
• Class 2 and 3 medical devices need more local
clinical trials; new exempt list too
• Approval in country of origin still required (can you
make in EU)
China Pricing and Reimbursement
• Pricing
–Oftentimes follows the national price list, but now
is determined more and more by the provincial
pricing bureaus (need to go province by province)
• Reimbursement
–Mostly for procedures with domestically made
products. If patient wants a foreign stent, they
must pay out of pocket
–Adjunct devices are normally not reimbursed

The Overall Market Access Process In China For
Imported Medical Device Products After Product
Approval
B B B B B
Patient-price Provincial
CFDA Hospital
application bidding & Patient
approval Listing
& approval procurement
▪ Reimbursement status is granted

National and P P
to a product category (by Product
Provincial MD
Code)
Reimbursement B
List(s) ▪ Everything else in Market Access
is brand-specific
▪ A complex, lengthy, and uncertain process

▪ First started in the late 90’s, and has been upgraded over the years in an effort to
ensure transparency, minimize corruption, and bring down the cost to the payer
and to the patient
▪ Since late 2014, more significant changes and experimentations throughout the
country have led to huge uncertainties.

THE PROVINCIAL/LOCAL PRICE OF HIGH-VALUE MEDICAL
Disposables And Implantables Have Come Down In The Last Couple Of
Years
Case study – GanSu Province Purchase Prices for Stent Products (2015)
National Catalogue - 2008 GanSu Province - 2015

Product
Product Name / Manufacturing Compared to 2008
Number Catalogue Product Sub-type Manufacturer Price (RMB) Price (RMB)
Brand Location National Price
Code
Stent, coated with
1451 08104301 rapamycin and Lepu (Beijing) Beijing ~15% reduction
10,800 9,100
derivatives
Stent, coated with
Shandong
945 08104301 rapamycin and EXCEL Shangdong JW ~15% reduction
Province 10,900 9,100
derivatives
Coronary
Stent, coated with
rapamycin, Eluting Shanghai
349 08104301 rapamycin and Shanghai ~15% reduction
stent system MircoPort 10,800 9,100
derivatives
(FIREBIRD)
Coronary
Stent, coated with
rapamycin, Eluting Shanghai
352 08104301 rapamycin and Shanghai N/A N/A
stent system MircoPort 11,000
derivatives
(FIREBIRD2)
Liaoning
Stent, coated with Liaoning
513 08104302 YINYI (垠艺) Biomedical ~15% reduction
Taxol Province 11,000 9,100
Materials
Stent, coated with
610 08104301 rapamycin and ENDEAVOR Medtronic Ireland ~30% reduction
16,500 10,100
derivatives
local made new product
Stent, non-drug-
1387 08104100 R-STENT OrbusNeich Holland N/A at RMB7,200 in GanSu
coated Sources: 2008 National Catalogue (for Cardio
5,800Intervention; GanSu Bureau of HRSS)
2015 Catalogue
Chinese Competitors: Look Out!
• Local Chinese medical devices compete with foreign-made
products (Lepu, MicroPort, etc.)
• Chinese government is financially incentivizing local device
companies to make innovative products
– Chinese hospitals are encouraged to buy China-made devices
• Locally made innovative products -- fast track registration
• Chinese locally-made products compete globally with
Western products in Brazil, Indonesia, etc.
• Chinese companies will acquire or invest in more Western
device companies in the future
– MicroPort purchased Wright Medical’s OrthoRecon business for almost
$300 million; this is just the beginning

• March 16th,2015 The China Association of
Medical Equipment (CAME), which is authorised by
the NHFPC, issued the first portion of the
Outstanding Domestic Equipment Catalogue,
covering digital X-ray, colour ultrasound and fully
automatic biochemical analyser machines. Of the
218 products submitted for consideration by 57
companies, 95 products from 27 companies were
selected. Despite many applications for products
manufactured in China by the local factories of
foreign multinational companies, all of the
products selected were from Chinese-owned
brands.
205 Made in China (MIC 2025)
•When initiated – May 19th, 2015
•What is point – substitute Chinese
manufacturing for international
foreign manufacturing, reduce
imports in China

•The Minister of MIIT, Mr.Miao Wei, and
the Chair of the National Health and
Family Planning Commission, Li Bin,
signed a cooperative agreement for
the two ministries to research and
develop locally-produced medical
devices and advance indigenous
innovation capabilities.

Which Specific Products Are Targeted?
The plan focuses on
• medical imaging equipment,
• medical robots,
• wearable medical equipment,
• mobile and remote diagnostic equipment,
• radiotherapy equipment,
• medical high value supplies,
• new medical biomaterials and equipment,
• new biodegradable materials,
• new implant materials and implant,
• medical device products based on tissue engineering technology,
• new medical biological dressings,
• minimally invasive treatment/implant products,
• rapid detection technology,
• gene detection products,
• high risk infection disease diagnosis reagents key technology and
• key aspects of the prospective standards of research.

Japan: Key Market Research Issues
•Has the opportunity been confirmed by good
primary research (size of market and growth
rate)?
•Have Japanese market research executives talked
to KOL’s about your product; not just Western
executives from a foreign manufacturing
company? Are the Japanese KOLs double
agents?
•Will the reimbursement justify the investment?
Best to know upfront to make sure you can have
Japan Distributor Search
•Takes time to find the right distributor/partner

•Moving registrations can be difficult and costly
•DMAH
•Continual follow-up a MUST to keep the
relationship and business moving forward
•Just because there is a market in the West does
not mean there is a market in Japan

Japan: New Regulatory Issues
• November 24, 2014 new regulations
• The Pharmaceutical Affairs Law (PAL) became the
Pharmaceutical and Medical Device Act (PMD Act)
• More products approved by third party certification
• QMS inspection has been simplified – conducted
according to product groups, not individual products
• FMA simplified – changed from license and accreditation
to just registration; key is GM of main manufacturing
facility
• Cellular and tissue products – less upfront clinical trials
• Software stand alone now
Japan Pricing and Reimbursement
Category Description
A1 (Inclusive) Included within the technical fee. No separate reimbursement is made for the
device itself. Product examples: gloves, gauze, sutures
A2 (Designated inclusive) Technical fee granted for use of the device or class of devices. No
separate reimbursement is made for the device itself. Product examples: MRIs, CTs, and
most types of capital equipment
B (Individual evaluation) “Me-too” products that are similar to other products on the
market. As a result, these products fit into existing technical fee and STM reimbursement
categories. Product example: CoCr hip stem
C1 (New function) New products based on existing products/therapies.
C2 (New function and New technology) New products that result in a new therapy or
procedure. No predicate product or treatment exists.
F Products that do not match the reimbursement system in place or are not suitable for insurance
coverage

Japan Pricing and Reimbursement
• Foreign reference pricing
• R-value
• Product not reimbursed, sales will be limited (except
aesthetics)
• New technology – better mousetrap, will
reimbursement increase or put in existing category
where the prices may or may not meet your
expectation and provide company profit
• Must be checked upfront, NOT after registration

Do the Right Market Research
Before You Start in a New
Country

Do Market Research and Develop Best Business
Strategy
• Client has new implantable permanent contraception device

• Client is trying to determine if there is an opportunity in
China
• In 2012, China was still under the “one child policy”
• Client requests Pacific Bridge Medical to examine the
situation and make recommendations

Strategy
The most popular methods for contraceptives are Condoms, Withdrawal
Method and Rhythm Method

Strategy
What’s your perception on contraceptive methods in terms of their
effectiveness?

Strategy
Currently IUDs followed by tubal ligation are the most common contraceptive
methods for married couples in China based on current usage…

Strategy
Physicians think Client #1’s product has clear benefits over tubal ligation, but
believe there are many hurdles for this product to succeed in China
Perceived • Non-invasive and quick recovery are significant benefits compared

Benefits with traditional tubal ligation.
• In cities, tubal ligation is a tiny market.
• All physicians felt irreversibility is a significant weakness of this

product
• Infrastructure: hystereoscope might serve as a hurdle of this product in

Perceived
the countryside where most tubal ligation surgeries are performed
Barriers
• Price: Birth control procedures (IUD placement and tubal ligation) are
almost fully reimbursed
• Therapy competition: Advanced IUDs are now more reliable and are
not that expensive

Strategy
Due to the large amount of investment required in marketing to overcome
the negative preconceptions related to permanent sterilization, we would
recommend a subsidiary or hybrid model
Advantages Disadvantages
Subsidiary •
•
Higher amount of control
Higher Gross Margins
• Higher upfront costs and operating
costs
• Greater market understanding • Requires more focus (diverts from other
• Better ability to brand and develop market endeavors)
• Takes longer to get up and running
National • Less distraction from other business

endeavors
•
•
Less control
Lower Gross Margins
Distributor • Lower upfront and operating costs • Lower Marketing Understanding
• Quicker to get up and running • Less ability to brand and develop market
Hybrid •
•
Higher amount of control
Greater market understanding
•
•
Lower Gross Margins than subsidiary
Higher upfront costs and operating
• Better ability to brand and develop market costs than national distributor
• Less distraction from other business
endeavors
• Quicker to get up and running
• Higher Gross Margins than National
Distributor
• Lower upfront and operating costs than
subsidiary

Strategy
Based on these costs and typical hysterioscopic procedure fees we estimate
the total cost of therapy at approximately 12K RMB.
USD RMB
Import Price $450 ¥2,835
VAT $188 ¥1,187
Dealer Cost $222 ¥1,397
Dealer Profit $166 ¥1,048
Hospital Profit $55 ¥349
Marketing Costs $0 ¥0
Service, Infrastructure and Training Costs $0 ¥0
Import Tax $18 ¥113
Insurance Costs $3 ¥20
Customs Costs $5 ¥28
Shipping & Storage Costs $1 ¥6
Retail Price $1,108 ¥6,983
Procedure Fee $397 ¥2,500
Total Therapy Cost $1,975 ¥12,445
Assumptions
1. Little to no investment by dealers in marketing and service, or training
2. Procedure Fee is similar to other hysterioscopic procedure fees in SH/GZ (2K-3K RMB)
3. Import Price is $450

Strategy
• Product registration 2.5 years including clinical study
$500,000.
• Reimbursement: Excellent reimbursement exists for current
procedures - IUD insertion, tubal ligation. What will
reimbursement be for new product?
• Patents: 3 exist in China; can they be enforced?

Strategy
Financial Projections:
Scenario 2: Moderate
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
Number of Affordable Couples 531,874 588,203 644,748 696,628 750,134 801,677 851,145 898,239 944,095 988,558 1,031,784
Percentage of Couples that would consider 5% 6% 6% 7% 7% 8% 8% 9% 9% 10% 10%
Number of Couples that would consider 26,594 32,351 38,685 45,281 52,509 60,126 68,092 76,350 84,969 93,913 103,178
Penetration Rate 1% 2.5% 4.0% 5.5% 7.0% 8.5% 10.0% 11.5% 13.0% 14.5% 16.0%
Total Units 266 809 1,547 2,490 3,676 5,111 6,809 8,780 11,046 13,617 16,509
Total Revenue $0.1M $0.4M $0.7M $1.1M $1.7M $2.3M $3.1M $4.0M $5.0M $6.1M $7.4M
Gross Margin 80% 80% 80% 80% 80% 80% 80% 80% 80% 80% 80% 80% 80% 80%
COGS $0.0M $0.1M $0.1M $0.2M $0.3M $0.5M $0.6M $0.8M $1.0M $1.2M $1.5M
Gross Profit $0.1M $0.3M $0.6M $0.9M $1.3M $1.8M $2.5M $3.2M $4.0M $4.9M $5.9M
Regulatory Costs $0.04M

Clinical Trial Costs $0.54M
Marketing & Education Costs $0.3M $0.5M $0.5M $0.6M $0.6M $0.7M $0.7M $0.8M $0.9M $1.0M $1.1M $1.2M
Product Launch $0.3M
Service & Infrastructure Costs $0.1M $0.1M $0.1M $0.1M $0.1M $0.1M $0.2M $0.3M $0.4M $0.5M $0.7M $0.8M
Total Costs $0.6M $0.0M $0.6M $0.6M $0.6M $0.6M $0.7M $0.8M $0.9M $1.1M $1.3M $1.5M $1.8M $2.1M
Total Operating Profit/Loss ($0.6M) $0.0M ($0.6M) ($0.5M) ($0.3M) ($0.1M) $0.2M $0.5M $0.9M $1.4M $1.9M $2.5M $3.1M $3.9M
Accumulated (Break Even) ($0.6M) ($0.6M) ($1.1M) ($1.6M) ($1.9M) ($2.0M) ($1.8M) ($1.3M) ($0.4M) $1.0M $2.9M $5.3M $8.5M $12.3M

Acquisitions/Joint Ventures
• Acquisition – do lots of due diligence and do not
overpay
–Staged payments, with incentives to keep management
interested
• Joint ventures – do lots of due diligence
–More companies call us for break-up help than setting up
joint ventures these days
• Make sure you know what you are buying

Due Diligence in Asia
• Can never do enough due diligence before investing

• Big companies often send 20 year olds to do due diligence
• Offering memorandums often lack sufficient detail
• Best way to do it is via phone calls (fake headhunters),
examining competition closely and looking for information
not in offering memorandums

• Device companies and investors oftentimes call us to do

this work. We only use experienced medical device
executives who know how to get the inside information
they need.
• ABC is a Chinese device manufacturer with a US office for
sales. They make disposable, relatively low tech device
products including syringes, IV products, urology,
respiratory, irrigation products, etc.
• ABC is looking for an outside investor to increase working
capital and pay for company expansion. They would like to
sell a 49% interest for $50 million.

• Offering memorandum can be misleading

• The offering memorandum says one of their competitors is Suzhou
Linhua.
• Suzhou Linhua produces a range of IV products. It is described as
presenting some competition in safety IV catheters and less
competition in enteral irrigation syringes.
• New information:
– This company is large, with at least 900 employees. It claims an annual
capacity of 120 million syringes and 80 million transfusion sets. It also
makes scalp vein sets, IV infusion sets, enteral feeding sets, and urine
bags. Its products do seem fairly basic, as stated in the offering
memorandum. It was established in 1989 with equipment imported
from Italy and Korea, and has done OEM for Medline, Bard, and ABC
in the past. In a 2004 comparison of urine bag suppliers, its products
were much cheaper than similar products from other suppliers.
Report from recent ex-ABC employees

Note: For this section, we called these people acting as headhunters.
• Mr. Xu, VP, Sales & Marketing, 2003-2005 (US)

• Mr. Xu said that ABC management had some problems
during his employment. Senior management was shifting,
and some people were into “kingdom-building.” Although
they have improved now, they are still struggling with who
they want to be. He claimed the owner turned down a $60
million sale to XYZ because he felt a sense of allegiance to
MNO. He said the people there are very honest.

• Visit their offices and check if what they say is accurate

• Although ABC told PBM during the visit that we are seeing
an irrigation syringe production area, we later heard from a
contact at another company that ABC actually sources all of
its irrigation syringes from their company (Suzhou Linhua
Medical Device Co.), and does not manufacture them itself.
We did not actually see irrigation syringes being produced,
just syringes. This was misleading and not true.

Other Business Development Strategies in Asia
• Can you license your device in China?
• Can you source more device components/products from
Asia?
• Increase sales to Asia, develop “B” line of products to
compete with Asian device manufacturers, less bells and
whistles
• What other Asian countries should you work in?

Reasons to Source or Manufacture in
Asia
• Some labor costs and manufacturing costs are cheaper – Vietnam,
India
• Quality in Asia is quickly getting better
• Able to make high volumes with established device manufacturing
bases in China
• More FDA/ISO factories in Asia now
• Device market growth is fastest in Asia; get closer to customers in
Asia
– Per capita income growth and the increasing middle class demand
better healthcare
– Increased number of hospitals/specialty health centers – new hospitals,
government investing a lot in healthcare coverage (i.e. Indonesia
universal coverage)
– More device reimbursement
• In some cases, it may not make sense to source or manufacture in
Asia if you want to (1) sell in the US/EU or (2) reduce supply chain
risks and/or freight costs, etc.
• Make a B-line of your product with less bells and whistles
Medical Device Manufacturing Moving to Asia
(to reduce cost in some situations and get closer to growing
Asian device markets)
2005 2015
US US
EU EU
Japan Japan
Other Other
(90% Asia)
*Sources: Frost and Sullivan, Department of Commerce, and other PBM sources

Manufacturing and Sourcing in Asia
• China costs have skyrocketed, but quality has also
improved.
• It may be cheaper for commodity devices and
components to be made in Vietnam and India
rather than China.
• Due diligence, close and continuous follow-up,
monitoring, audits, and QA will be key.

India

TAJTaj
MAHAL,
Mahal, AGRA
Agra

India: Medical Device Market
• India’s medical device market is growing faster than at
any time in the last decade, with a projected growth rate
of 12-16% over the next several years.
• With a population of 1.2 billion and a growing middle
class, India has the potential for strong growth.
• India’s medical device market is dominated by foreign
device companies, which control roughly 70% of the
market.

India:
Current List of Notified Medical Device Families
Requiring Registration
S.No Name of the Device Notification Date of
Number Notification
1 Disposable Hypodermic Syringes GSR 365 (E) 3-17-1989
2 Disposable Hypodermic Needles GSR 365 (E) 3-17-1989
3 Disposable Perfusion Sets GSR 365 (E) 3-17-1989
4 In vitro Diagnostic Devices for HIV, GSR 601 (E) 8-27-2002
HBsAG and HCV
5 Cardiac Stents S.O. 1468 (E) 10-6-2005
6 Drug Eluting Stents S.O. 1468 (E) 10-6-2005
7 Catheters S.O. 1468 (E) 10-6-2005
8 Intra Ocular lenses S.O. 1468 (E) 10-6-2005
9 IV Cannula S.O. 1468 (E) 10-6-2005
10 Bone Cements S.O. 1468 (E) 10-6-2005
11 Heart Valves S.O. 1468 (E) 10-6-2005
12 Scalp Vein Set S.O, 1468 (E) 10-6-2005
13 Orthopedic Implants S.O. 1468 (E) 10-6-2005
14 Internal Prosthetic Replacements S.O. 1468 (E) 10-6-2005

India:
Additional List of Notified Medical Device Families
Requiring Registration
1. Blood Grouping Sera
2. Ligatures, Sutures and Staplers
3. Intra Uterine Devices (Cu-T)
4. Condoms
5. Tubal Rings
6. Surgical Dressings
7. Umbilical Tapes
8. Blood/Blood Component Bags

India
• New medical device requirements start January 1, 2018
• Only existing families will require registration (CDSCO)
through 2020
• However, may be adding families/products in future
• Manufacturing licenses for class A and B responsibility of the
State licensing authorities, class C and D under CDSCO
(central)
• Notified bodies will become more relevant-3 NBs already
accredited
• Price Controls, watch out!

India: Device Regulatory Update
• Recently, Prime Minister Narendra Modi’s Ministry of Health

published a 108 page notification on medical devices in India.
Significant changes to medical device regulations include:
–Device licenses will no longer expire. The manufacturer will
need to pay a renewal fee every 5 years to continue marketing
the product.
–Device registration approval for imported devices will take an
estimated maximum of 9 months. Registration will
automatically imply import license and will eliminate the 3
month wait for an import license.
–If the Ministry of Health fails to complete a regulatory process
in a pre-determined amount of time, then the license will be
“deemed” to be approved.
• The new regulations will come into effect January 2018.

Nizamia Hospital

Vietnam: All Imported Devices Now
Require Registration
• Vietnam has new regulations that now require registration for all
medical devices imported into Vietnam. Starting in 2017, all
imported medical devices are required to be registered for
marketing authorization licenses.
• Previously, only 24 items required registration, and the license was
valid for 12 months. Now, all medical devices must be registered.
The device licenses for Class A products lasts forever, and the
licenses for Class B, C, and D devices last for five years.
• The import licenses of companies currently selling imported Class
A medical devices will only be valid until June 30, 2017. Import
licenses for medical devices in all other classes will be valid only
until December 31, 2017.
• The Ministry of Health began receiving registration dossiers for
Class A medical devices on January 1, 2017, and will start receiving
registration dossiers for Class B, C, and D medical devices on July
1, 2017.
Asian Ethnic Diversity
• Japan and Korea: very homogenous; small minority populations
• China: 92% Han, Over 50 National Minority Groups for other
8%
• Singapore: 77% Chinese, 14% Malay, 8% Indian
• Malaysia: 50% Malay, 24% Chinese, 7% Indian
• Indonesia: 40% Javanese, over 300 ethnic groups for other 60%
• Thailand: Majority Thai, 14% Chinese
• Philippines: Very diverse population in terms of language,
religion and ancestry
–Tagalog 28%, Cebuano 13%, Ilocano 9%, Bisaya/Binisaya 8%,
Hiligaynon Illonggo 8%
• Vietnam: over 50 ethnic groups
–Almost 90% Vietnamese
–Chinese (Hoa) around 1%
• India: 3 major groups
–72% Indo-Aryan, 25% Dravidian, 3% Mongoloid and other

Relationships of trust is how business
is done in Asia
• Relationships take time in Asia, unlike in the West.
• How do you write your emails to the Japanese?
• Do you send holiday cards and do you write hand
written messages on the holiday cards?
• Have you made an effort to understand the history
and culture in the Asian countries you are working
with?
• Good relationships can always deal with difficult
problems. Lawyers do not dominate the regulatory
and business practices in Asia, and should be used
rarely.
T H A N K Y O U
FOR YOUR PA RTI C I PATI O N AND AT TEN TIO N
For more information, visit us at

www.pacificbridgemedical.com
Connect with us today:

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2017.10.18 MDMA Webcast

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2017.10.18 MDMA Webcast

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BEST STRATEGIES TO SUCCEED IN

MDMA Webcast: October 18, 2017

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PACIFIC BRIDGE MEDICAL (PBM) is a leading medical consulting firm dedicated to

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China $8,000 6.4% $21.3 trillion 6.7%

Source: World Bank and other PBM sources

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▪ Reimbursement status is granted

▪ A complex, lengthy, and uncertain process

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National Catalogue - 2008 GanSu Province - 2015

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•Takes time to find the right distributor/partner

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• Client has new implantable permanent contraception device

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Perceived • Non-invasive and quick recovery are significant benefits compared

• All physicians felt irreversibility is a significant weakness of this

• Infrastructure: hystereoscope might serve as a hurdle of this product in

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National • Less distraction from other business

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Regulatory Costs $0.04M

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• Can never do enough due diligence before investing

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• Device companies and investors oftentimes call us to do

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• Offering memorandum can be misleading

Report from recent ex-ABC employees

• Mr. Xu, VP, Sales & Marketing, 2003-2005 (US)

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• Visit their offices and check if what they say is accurate

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• Recently, Prime Minister Narendra Modi’s Ministry of Health

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