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Transcript of Nanotech
Proactive Consultants
N A N O T E C H�Non-Transdermal Patches
Target Market: India Launch Date: June 2011
Executive Summary
PEST Analysis
Legal Requirements
Entry & Local Marketing Strategies
Financial Requirements
Market Size & Growth Potential
Competition Evaluation
Strategic Plan
Management & Supply Chain
Nanotech Products
Non-transdermal Patches
Sleep Aid
Energy
Pain Relief
Weight Loss Anti - Aging
Passive medical devices that are activated by the interaction of molecular structures with the body’s own natural incident
Electromagnetic emissions.
Energy Drink Market Size
Source: www.istockanalyst.com
v Energy drinks are non-alcoholic beverages which are intended to provide a quick burst of high energy to the consumer.
v May be prepared with a composition of methylxanthines, caffeine, natural flavors, some herbal components or specific vitamins including Vitamins.
v May also contain taurine, guarana, maltodextrin, ginseng, carnitine, inositol, glucuronolactone, creatine and ginkgobiloba.
v Most products include artificial sugar.
v The primary active component is generally caffeine.
Pain Relief Market Size
v Indian pharmaceutical market accounts for 1-2% of the global pharmaceutical market in value terms and 8% in volume terms.
v In 2007 it has grown by 12.9% to reach USD8.16 billion.
v Market growth during 2007 was driven by a number of new product launches by both Indian and foreign companies.
v The pharmaceutical market has grown at a compounded annual growth rate (CAGR) of 13% during the last five years.
v The market size comprises of domestic consumption of bulk drugs and formulations and does not include exports of the same.
Sleep Aid Market Size
v Sales for drugs targeting sleep disorders constitute close to half of total revenues, with another 29% coming from drugs that alleviate pain.
v About 42 million sleeping pill prescriptions were filled in 2005 which is up nearly 60 percent since 2000!
v Experts acknowledge that insomnia has become a cultural benchmark — a side effect of an overworked, overwrought society.
Anti-Aging Market Size
v The global market for anti-aging products and services was worth $162.2 billion in 2008.
Weight Loss Market Size
v Between $33 billion and $55 billion is spent annually on weight loss products and services, including medical procedures and pharmaceuticals, with weight loss centers garnering between 6 percent and 12 percent of total annual expenditure.
v About 70 percent of Americans' dieting attempts are of a self-help nature. Although often short-lived, these diet fads are a positive trend for this sector as Americans ultimately turn to professionals to help them meet their weight loss goals
Source: www.themarketfinancial.com
Growth Potential
courtesy of www.bigcharts.com
v By Year 2050, India will be the World’s 3rd Largest Economy
v India has consistently improved over the last 17 years.
India is one of the World’s Top Investment Destinations
v The Indian economy posted robust growth of 9.4% in 2006-07. Despite a sharp deceleration in the agricultural sector, the strong GDP growth of 2006-07 was mainly powered by impressive growth of 10.0% in industry and 11.0% services.
POLITICAL, Economic, Social, & TECHNOLOGICAL Analysis
v No strict regulations for the product.
v Network marketing has been legal in India since 2000.
v India lacks related laws or guidance. They are still working on how to define pyramid scheme vs. true network marketing.
v NM is expanding at a phenomenal growth rate while scams are worse than the U.S. or Singapore.
v IDSA: an interface between the industry and policy-making bodies of the Government facilitating the cause of Direct Selling Industry in India.
v Establishment of technological and research institute § 500 technological institutes & 1080 research
institutes for providing education to Indian students.
v Positive Technical policy § Opens door to import technology from foreign
countries for increasing agricultural and industrial developments.
v High Growth Rate of IT in India § 35% growth rate, 2nd country after China who
is using internet at large scale for ecommerce , e-education and e-accounting.
v Incentive for promoting technology § 100% income tax exemption for expenses
incurred in research of technology in India. § State financial corporation is uplifting
domestic technology by supporting finance to domestic Industries.
http://economictimes.indiatimes.com/Analysis/Remove_policy_ambiguity_on_direct_selling_industry/articleshow/3483601.cms http://shiksha-mba.blogspot.com/2009/11/what-is-technological-environment-and.html
Political, ECONOMIC, Social, and Technological Analysis
v The economic factors in India are improving continuously § GDP - Among the growing economies of the world, India is second only to
China. The country's GDP has been growing at an average rate of 8.5% for the last 5 years. its GDP is expected to increase 7.5% in 2011
v Domestic consumption fuelling economic growth § India has the largest independent consumer market in the world. As compared to
other countries, India is relatively insulated to external shocks due to strong domestic consumption.
§ Private domestic consumption accounts for more than 50% of the country's GDP and is one of the key factors driving overseas investments in the country
§ Income per capita: $884.75(2009)-->$977.41(2010) 10.5% increase!
FY05 FY06 FY07 FY08 FY09 FY10 FY11
Growth Rate 7.5% 9.5% 9.7% 9.0% 6.7% 6.5% 7.5%
Private Consumption Expenditure
$378Bi $423Bi $467Bi $534Bi $601Bi NA NA
Source: www.cmie.com
Political, Economic, SOCIAL, and Technological Analysis
v Collectivism § Extremely people-oriented, community conscious, large in-group § Indian make their goals around people of the family/friends. § Believe in long term relationships. Respect human relationships. § Indians are known for their hard work vitality and dynamism, they enjoy working
as members of a group.
v Value § The spirit of competition is more in Indians as compared to Americans. § Careless about the value of time.
v Belief in natural treatment § Treatment of health is not based only on the use of medications natural & herbal
healing (no chemicals inputs) § Yoga - a spiritual and traditional practices § Meditation - done though mind along with breathing exercises have a direct effect
on the body and helps in treating its various disorders.
http://www.healthaidindia.com/
INDIA is a great market to enter!
5 types of patches Network Marketing
4
No restriction on products
+ Network
marketing is allowed in India
5
People Oriented &
Acceptance of Natural Treatment
4
Positive Technological Development &
Strong Related Policy
4
Sustained Economy Growth &
Strong Domestic Private Consumption
4+4+5+4=17 17 ÷ 4 = 4.25
Legal Requirements v Approval needed
§ CDSCO (Central Drugs Standard Control Organization)
• Ministry of Health and Family Welfare
http://cdsco.nic.in/index.html
http://cdsco.nic.in/index.html
Location: FDA Bhavan, ITO, Kotla Road, New Delhi -110002
Phone: 91-11-23236965 / 91-11-23236965 Fax: 91-11-23236973
http://cdsco.nic.in/index.html
Legal Documents (Product Registration)
Guidance Document on Common Submission Format for Registration of Medical Devices in India http://cdsco.nic.in/Guidance%20Document%20on%20Common%20%20%20Submission%20Format%20for
%20Registration%20of%20Medical%20Devices%20in%20India.Pdf
Plant Master
File
Covering Letter
Authorization Letter Form 40
Inspection/ Audit Report
Free Sales Certificate Schedule
DII
Schedule DI
Power Of Attorney
TR6 Challan
LEGAL DOCUMENTS
Legal Documents - I v Cover Letter
§ Cleary specify the intent of the application. § Provide important and relevant information.
v Authorization Letter § Original issue by Director / Company
Secretary / Partner of India Agent v Form 40 **
§ Performa prescribed in the Drugs & Cosmetics Rules
Guidance Document on Common Submission Format for Registration of Medical Devices in India
http://cdsco.nic.in/Guidance%20Document%20on%20Common%20%20%20Submission%20Format%20for%20Registration%20of%20Medical%20Devices%20in%20India.Pdf
Legal Documents - II v TR6 Challan **
§ Requite Fee • USD 1500 – Registration of the manufacturing
Premises • USD 1000 – Single device • USD 1000 – Each additional device
v Power Of Attorney ** § Authorization by a manufacturer to agent in
India shall be documented by POA executed.
Guidance Document on Common Submission Format for Registration of Medical Devices in India http://cdsco.nic.in/Guidance%20Document%20on%20Common%20%20%20Submission%20Format%20for
%20Registration%20of%20Medical%20Devices%20in%20India.Pdf
Legal Documents - III v Schedule DI **
§ Undertaking as per the Performa prescribed in the Drugs & Cosmetics Act & Rules.
v Schedule DII v Free Sales Certificate
§ Issued by GHTF (Global Harmonization Task Force) member.
• Enhancing patient safety • Increasing access to safe, effective and clinically
beneficial medical technology around the world.
Guidance Document on Common Submission Format for Registration of Medical Devices in India http://cdsco.nic.in/Guidance%20Document%20on%20Common%20%20%20Submission%20Format%20for
%20Registration%20of%20Medical%20Devices%20in%20India.Pdf
Legal Documents - IV v Inspection / Audit Report
§ Latest copy carried out by Notified bodies / National Regulatory Authority.
Notes: Soft Copy of the Plant Master File ** may submitted
along with the application. ** Refer to Appendix
Guidance Document on Common Submission Format for Registration of Medical Devices in India http://cdsco.nic.in/Guidance%20Document%20on%20Common%20%20%20Submission%20Format%20for
%20Registration%20of%20Medical%20Devices%20in%20India.Pdf
Import Duties v Harmonized Tariff Code (HTS)
§ 3005.10.90 • Duty – 10%
http://www.cbec.gov.in/customs/cst-0910/chap-30.pdf
Competitor’s Evaluation v Companies v Products
Network Marketing
v No. 1 Amway § turnover 800 crores = 8 billion dollars ( 10 crores = 23,32,627.85 US Dollars ) § 16.9% market share
v No. 2 Avon § turnover 180 crores =1.8 billion dollars § 3.8% market share
http://in.answers.yahoo.com/question/index?qid=20080615230715AAwxvwi http://www.business-standard.com/india/news/amway-dabur-to-sweat-it-out-over-vitamins-dietary-supplements/357463/
How to join… Amway
v Start-up price § Rs 995 = $ 22.2 § All Product Handbook § A set of 2 CDs
• Opportunity CD • Product CD
v Buying products regularly
Avon
v Start-up price § A little more than the price
of a lipstick
http://www.amway.in/Articles/Article.aspx?pid=3e3b6905-209e-442e-b8a8-9a0980241c6s&ctg=CompanyProfile
Energy Drink Market
Red Bull Power H Others
Energy Drinks (Total turnover Rs 500 cores)
Product Red Bull Power Horse
Others (AmwayXL, Bullet, etc.)
Market share
60% 22% 18%
Country Base
Australia Australia Vary
Price $2/250ml (Rs95)
$2/250ml (Rs96)
Vary
Distribution/Strategy
Buzz-Marketing
HoReCa 60% Retail 40%
Retail, Direct Sell etc.
Nanotech V.S. Traditional Energy Drinks
Nanotech Energy Patch Energy Drinks
Caffeine-Free Drug-Free Stimulant-Free
Caffeine Stimulant
http://www.thehindubusinessline.com/2003/01/02/stories/2003010202060600.htm http://marketingpractice.blogspot.com/2008/08/red-bull-it-gives-you-wiings.html http://www.citeman.com/4318-market-size-for-energy-drinks-in-india-is-growing-rapidly/
Popular Pain Relief Products
v Ayurveda § Ayurvedic Medicine
v Herbal Oil, Cream etc. § Zandu Balm (under Emami)
• 65~67% Market share • $0.5 ~ $1.5 (Local Price) • $ 2 up ( Online for Worldwide)
http://business.rediff.com/report/2010/sep/27/dabangg-moment-for-zandu-balm.htm
Products that similar to Nanotech
v Salonpas v Ben Gay v Tylenol v Icy Hot Only Online
Beauty Industry
v Hindustan Lever, Ltd § Market share vary (average 30~55%) § 250+ personal care products from H to T
• $8 ~ $15
http://www.hul.co.in/ http://en.wikipedia.org/wiki/Hindustan_Lever_Ltd
Beauty International
v Market share around 23% v 30 million dollars on local manufacturing
since 1994 v YES to fairer and younger looking skin” or
“Against inside cell damages.” v “Fairness” is the most important thing for
Indian women
http://www.loreal.co.in/_hi/_in/maybelline.aspx http://www.indiatogether.org/manushi/issue145/lovely.htm http://www.nytimes.com/2007/05/30/business/media/30adco.html?_r=1
Weight loss v Phentramin-d (no need doctor’s
prescription) § 60ct $67 § 120ct $127 § 180ct $157 § 360ct $314 § 540ct $471
v Thermo Phen Phen § 100ct $29.99
both claim to reduce appetite and enhance metabolism
Global “Entry” Strategies Strategies Entry sopport
Trade (Export) Strategy
Very traditional and well established form of operating in foreign market
Licensing Strategy -Valuable product and unique technology
-Loyalty fee
Foreign Investment Strategy
-Long-term participation
-Reduces investment of both money and management
Network Marketing -Not a traditional, but a powerful strategy
-The consultant gets a chance to do business without any investment -The end customers get genuine product
Global “Entry” Strategies Strategies Pros Cons
Export strategy Least effort approach to enter foreign market
Least development of market potential
Licensing strategy -Product customization -Avoiding potential risks due to unfamiliarity
-Potential loss of trademark, patent -May create a potential competitor
Foreign Investment
-A good way to occupy foreign market with unique technology
-Must share profits & relationship with partner -different standards
Network Marketing
-Minimum capital involved -Simple transaction -Powerful strategy -Everyone could be the top -No money investment, but profitable
-More people involved -Illegal way in some countries -Hard to start -Depends highly on the product quality
Global “Entry” Strategies Network Marketing is the best strategy to enter Indian Market: --Network Marketing is a strategy entering India market with
the maximum impact at minimum cost among all of other strategies
--It is a powerful tool with word of mouth marketing, no
advertsing budget --The consultant gets a chance to do business without
any investment, and the customers get the genuine product --A good way for a start business
Local Marketing Strategy v Product
§ Brand Name: Nanotech Inc. § Type of Product: Improving health and
wellness § Product Feature:
• Non-Transdermal patches • Patch for Energy, Pain, Sleep, Anti-Aging, and
Weight Loss • FDA-Approved Class II Device
§ Appearance: form of a small patch, slightly bigger than a ‘quarter’ coin
§ Usage: Disposable and may be applied daily for up to 12 hours at a time
Local Marketing Strategy v Price
§ Premium Pricing Strategy • High prices is interpreted as high quality product • High prices reflect the exclusiveness of the product
§ Price Breaks: • Volume quantity discounts are available to distributors
at $50 per pack for an order of 50 packs of the same product.
§ Target the middle-upper class • Retail: $90+$15 (shipping) = $105
– 4705 rupees • Wholesale: $70+$15 (shipping)=$85
– 3809 rupees
Local Marketing Strategy v Promotion
§ Direct/personal Selling § Sales Promotion
• Lifestyle Store • Give a free trial/sample patch
§ No advertising as it does not fit company budget/structure
§ Testimonials: From people and show the celebrities that use it
§ Word of mouth: If the product is good it will sell itself
§ Have a athletes in India try it • Cricket • Field Hockey
Local Marketing Strategy v Place
§ Direct Distribution • Goes from Distributor to Consumer • Small stock of inventory
§ Distribution Center – Mumbai • Have airport and sea port • Metropolis
Distribution Center in India Consu
mer
Nanotech
Management & Supply Chain v Organizational Structure
U.S Indian Distributor Assistant
Local Distributor
A B
a a b b
Network Marketing
Supply Chain System
US Warehouse
LAX US Freight
BOM airport Bonded warehouse
India Distribution Center
Indian Online Website
Distributors
3 days
30-35 days
Logistic/Distribution v Mode of Transportation
§ Ocean • U.S Freight Forwarder- takes 30-35 days
– Quarterly
§ Air • Cargo Airline- takes 3 days
§ Rush • Courier- takes 1-3 days
– USPS, Fedex, DHL, UPS
v Local § Indian Post Office
Financial Requirements Total legal costs involved in setting up the business in India
20 days (min) INR 31,073 (max) = USD 692
Source: International Finance Corporation (2010). “Doing Business in India.” http://www.doingbusiness.org/data/exploreeconomies/india. Accessed on Nov 20, 2010
USD1 = INR44.90
Financial Requirements Product Registration Costs with Central Drugs Standard
Control Organization (CDSCO)
*One time fee while filing TR6 Chalan, unless if there are
additional medical device in different shape and size.
Source: Guidelines for Import and Manufacture of Medical Devices(2006),“Registration for medical devices for import” http://cdsco.nic.in/medical%20device%20A42.html. Accessed on Dec 4th 2010.
Item Total Cost Registration Fee* $1500 Registration of Medical Devices for Import*
$1000
Total $2500
Financial Requirements Total Promotion and Marketing Cost
Promotion and Marketing Cost Costs Free Samples 0 (at Distributor's
own cost) Training Seminars Free Marketing Materials (DVD, brochures, information kit)
$500
Total $500
Financial Requirements Total Shipping/Transportation Costs Analysis
*Quotes obtained from The Ultimate Freight Management, Inc **Quotes obtained from Global Logistics Solutions (India) Pvt. Ltd.
Ocean Freight Air Freight (based on SQ airline)
Port Item Costs Airport Item Costs
Ocean Freight $1,984 45kg of products ($4.95/kg) $223
Handling Fee $65 Security ($0.15/kg with $15min) $15
Export AES Custom $85 Fuel ($0.90/kg with $15min) $41
Pier Pass $50 LAX Airport Cargo Transfer $25
Clean Truck Fee $35 Export Document $65
THC for 20' Non Haz Cntr $133 Export AES customs $85
Document Charges $35 Local Trucking Fee $160
Service Tax of 10.3% $17 Document Charges $35
Clearance Charges $125 Service Tax of 10.3% $4
Handling Fee $25 Clearance Charges $125
-‐ -‐ -‐ Handling Charges $25
$2,554 $802Total Total
US*
LAX*
BOM**
Mumbai**
Financial Requirements Total Shipping/Transportation Costs Analysis
Ocean Freight
Container Dimension (LxWxH) 20’ x 8’ x 8’
Assumed No. of packs in 1 Container 252,700 (=38x14x475)
Ocean Freight Cost/container $2554
Import Duty Tax (10% of Product Value) $1,768,900
Ocean Freight Cost/Pack $7.00
Air Freight
Total Weight for Air Shipment 45kg = 99lbs
Assumed No. of packs in 45kg = 99lbs 198
Air Freight Cost/45kg $802
Import Duty Tax (10% of Product Value) $1,386
Air Freight Cost/Pack $11.00
Courier Service
Large Flat Rate Box Dimension (LxWxH) 12’”x 12’”x 5-1/2’”
Assumed No. of packs in 1 above Flat Rate Box 40
USPS Priority Mail Large Flat Rate Box (up to 20lbs) $55.95
Ocean Freight Cost/Pack $1.40
Assume: 1 pack weights 0.5lbs Pack Dimension (LxWxH) = 6”x6”x0.2”
Financial Requirements Total Channel/Distribution Costs
Item Cost/Unit Qty Needed Total Cost
Wholesale Price/pack
$70.00 240 (48x5 products)
$16,800
Recruiting Bonus
Up to $100 50 $5,000
Total $21,800
Financial Requirements Total Management & Operational Costs
Source 1: Commercial: Office Space/IT park for Rent in East Vidyavihar (2010). “Sulekha.com Classifieds & Yellow pages”. <http://classifieds.sulekha.com/mumbai/vidyavihar-e/rentals/commercial-office-space-it-park/adlistings.aspx>. Accessed on Dec 4th 2010 Source 2: Home fixed line plans from Airtel (2010). “Airtel India”. <http://www.airtel.in/wps/wcm/connect/airtel.in/airtel.in/home/foryou/broadband+and+fixed+line/fixed+line/tariffs/>. Accessed on Dec 4th 2010. Source 3: Salary Report for Clerk @ Jobstreet.com (2010). “Jobstreet.com”. <http://myjobstreet.jobstreet.com/career-enhancer/basic-salary-report.php>. Accessed on Dec 4th 2010
Source 4: Broadband Internet Plans in India (2010). “Airtel India”. <http://www.airtel.in/wps/wcm/connect/airtel.in/airtel.in/home/forme_newuser/broadband+and+fixed+Line/broadband/>. Accessed on Dec 4th 2010
Management & Operational items Costs/month
1Office Rental (500sqt) in Mumbai $1,115 2Airtel Fixed Line Bill $25 3Clerk (Fresh/Entry Level) Salary $190 Estimated Electric Bill $135 Estimated Water Bill $15 4Airtel Broadband Bill(2Mbps download speed)
$40
Total $1,520
Financial Requirements Total Financial Requirements
Costs Amount (USD)
Total Legal Costs in Setting up Business in India
$692
Total CDSCO Registration Fee $2,500
Total Promotion and Marketing Costs $500
Total Shipping/ Transportation Costs (1st batch, 240packs – using Courier Service)
$336
Total Channel/Distribution Costs $21,800
Total Management & Operational Costs $1,520
Total $27,348
Balance Cash on Hand: $22,652
INDIA
Strategic Plan to Launch Nanotech Patches into
Nanotech’s Vision and Mission
Our Vision
Our Mission To help transform health care
by bringing together the basic principles of science and technology for the purpose of
living life to its fullest!
To enhance human health and well being all over the world through nanotechnology
“One patch at a time.”
Nanotech Goal and Objective
Goal Objective
Nanotech patches to be accepted,
purchased and enjoyed by
everyone in India.
To become one of the top 3
network marketing companies in India within 3 years by increasing sales
30% - 50% per year.
Evaluation of Strategies Strategies Pros Cons
Export strategy Least effort approach to enter foreign market
Least development of market potential
Licensing strategy -Product customization -Avoiding potential risks due to unfamiliarity
-Potential loss of trademark, patent -May create a potential competitor
Foreign Investment
-A good way to occupy foreign market with unique technology
-Must share profits & relationship with partner -different standards
Network Marketing
-Minimum capital involved -Simple transaction -Powerful strategy -Everyone could be the top -No money investment, but profitable
-More people involved -Illegal way in some countries -Hard to start -Depends highly on the product quality
Optimal Strategy v Network Marketing Strategy with
distribution center in Mumbai
U.S Indian Distributor Assistant
Local Distributor
A B
a a b b
Network Marketing
Timeline (January 2011 – June 2011)
Develop & implement accelerated market
entry and deployment plans
JAN
FEB
MAR
MAY
Prepare comprehensive business plan
Recruit key staff
USA & India
Acquire facility and
shipping mechanisms
LAUNCH PRODUCT JUNE 2011
Proactive Consultants
Angel Huang, Annie Ting, Cynthia Wang, Helen Miao, Pockey Wu, Jeffrey Shih, Oliver Hament, Peong-Tat Ong
Resources Articles / Reports v Doing Business in India, 2010, Ernst & Young, India v Doing Business in India, Strategic and Practical Considerations, January 2010, IVG Partners v Doing Business in India, January 24, 2008, Citibank v Transdermal Patches: What Pharmacists Need to Know?, The Pharma Review June 2006, Subal C. Basak v India’s market Opportunities for imported fresh & processed foods, May 2009, Dept. Agriculture & Food v Is the Health and Wellness Industry ‘Recession Proof’?, www.zpryme.com,
Resources Websites v National Council of Applied Economic Research www.ncaer.org v http://www.wikipedia.com v http://www.wikiinvest.com v http://www.nytimes.com v http://www.ahrq.gov/ v http://cdsco.nic.in/index.html v http://cdsco.nic.in/Medical_div/General%20Formats.htm v http://cdsco.nic.in/Guidance%20Document%20on%20Common%20%20%20Submission%20Format%20for
%20Registration%20of%20Medical%20Devices%20in%20India.Pdf v http://www.fda.gov.tw/files/list/PMF_Checklist_en.pdf v http://business.mapsofindia.com/india-company/pharmaceutical.html v http://www.dare.co.in/news/others/indias-wellness-industry-seen-growing-30-35-percent.htm v http://www.wyff4.com/r/25676048/detail.html v http://www.tradeindia.com/manufacturers/indianmanufacturers/energy-drinks.html v http://www.rediff.com/money/2006/may/24drink.htm v http://www.rediff.com/money/2006/apr/19spec.htm v http://medicinemadeinindia.com/siddha.html v http://lifestyle.iloveindia.com/lounge/herbal-sleep-aids-8848.html v http://www.herbalcureindia.com/products/wheat-grass.htm v http://www.healthylivingindia.org/2010/06/ayurvedic-weight-loss-pills-dont-work.html v http://www.made-from-india.com/Categories/Medicine_Health_Products/?page=8&vc=product&sortby v http://www.cosmeticsdesign.com/Products-Markets/Anti-aging-prestige-skincare-market-set-to-return-to-growth
Appendix I
http://cdsco.nic.in/Medical_div/General%20Formats.htm
Appendix II
http://cdsco.nic.in/Medical_div/General%20Formats.htm
Appendix III
http://cdsco.nic.in/Medical_div/General%20Formats.htm
Appendix IV
Guidance Document on Common Submission Format for Registration of Medical Devices in India http://cdsco.nic.in/Guidance%20Document%20on%20Common%20%20%20Submission%20Format%20for
%20Registration%20of%20Medical%20Devices%20in%20India.Pdf
Appendix V
http://www.fda.gov.tw/files/list/PMF_Checklist_en.pdf