1. Dr. G. Gautham Shenoy
Professor
Dept. of P’ceutical Chemistry
MCOPS
Manipal University
Manipal
Mr. Sudhakar Mairpadi
General Manager
(Quality and Regulatory)
Philips Health Care Sector
Gurgaon
Haryana

2. 1. Introduction.
2. Objective.
3. Factors affecting the medical equipment market Scenario in Sri
Lanka.
3. Total Expenditure on health.
4. Expenditure on capital formation.
6. Purchase mode in public sector

3. 7. Medical Equipment market.
8. Registration of a company in Sri Lanka.
8. Registration of medical devices to CDDA Sri Lanka.
9. Registration of medical devices to Atomic Energy Authority
Sri Lanka
10. Import registration and procedure
11. Comparison- Regulatory requirements in India and Sri Lanka
12. Conclusion.

4. 1. Demography.
2. Economy.
3. Disease Pattern.
4. Health policies.
5. Regulatory Authorities.

5. 1. To understand the health profile of the country.
2. To analyze the Total Healthcare Expenditure and its trend.
3. To analyze the fraction of THE spent on capital formation.
4. To analyze the critical parameters that would affect the business trend,
market size and its expansion.
5. To understand the market size of medical equipments.
6. To evaluate the possibilities of penetrating and expanding the market
size.
7. To understand the regulatory requirements for the process of registration,
importation requirements of medical equipments in Sri Lanka.

6. 1. Demography.
2. Disease Pattern.
3. Economy.
4. Health Policies.
5.Total expenditure on healthcare.

7. Ageing trend comparison past present and the future
Year Percentage of older population
1995 8.1
2005 9.7
2015 12.3
2020 14.5
2025 17.2

8. 0
2
4
6
8
10
12
14
16
18
1995 2005 2015 2020 2025
Ageing trend comparison
%
o
f
e
l
d
e
r
p
o
p
u
l
a
t
i
o
n Year

9. Sri Lanka is experiencing the double burden of diseases, as the
country is facing an epidemiological transition, while still being
affected by Communicable Diseases, non communicable diseases
such as cardiovascular diseases, mental disorders, diabetes
mellitus and cancer are emerging more strongly in the morbidity
and mortality patterns. In 2004 cardiovascular disease ranked 1st
as the leading cause of hospital deaths, prevalence of diabetes has
doubled in ten years.

10. Cases per 100,000 population
Diseases Year
1980 1985 1990 1995 2000 2005 2010
CVD
117.3 163.9 163.2 263.3 313.2 353.9 510.2
Cancer 128.3 121.3 142.1 190.1 260.2 282.2 510.2
Mental
Disorders 298.0 315.9 337.9 434.0 490.4 465.9 -
Diabetes 65.6 86.6 87.5 78.6 204.8 256.2 380.2
Trend of hospitalization due to NCDs

11. Sri Lanka is a mixed economy country, where both public and
private sectors are engaged in production process. Foreign
investments are encouraged . Sri Lanka is committed to a free
market ideology and has one of the most liberal foreign regimens
in the world.
Sri Lanka is a lower middle income developing nation with per
capita income of 2000 USD.
Despite the brutal war the country’s economic growth was
around 4.5 percent. Economy grew more rapidly at the rate of 6
percent in 2003. The expected growth rate is percent in 2010.

12. The healthcare network is run by both the public and private sector. The
government has managed to maintain a network of public health,
around 608 hospitals that are widely accessed and used by all income
groups. The number of private sector hospitals has also increased
considerably, in the 1990s there were only around 85 private hospitals
but at present there are 152 private hospitals.
The public healthcare expenditure as percentage of total healthcare
expenses was 5.3 percent in 1970s, declined to 3.48 percent in 1990s
and again raised to 3.94 percent in 2000s.

13. The private expenses have risen consistently and modestly which is
higher than the public expenditures. Expenditure for NCDs are
already the major complication of spending in Sri Lanka and their
share is likely to increase in the next few decades, particularly those
for CVD, DM, Cancer and mental disorders.

14. Budgetary
Resources
Year
TEH as percentage
of GDP
1995 2005 2015 2025
3.5 4.1 4.5 4.6
PEH as percentage
of GDP
1.6 1.9 2.3 2.5
Pvt. EH as
percentage of GDP
1.8 2.2 2.2 2.1
Estimated health expenditure by finance sources

15. The private sector has grown to take up the demand for applicability of
high tech medical equipments like MRI, CT scan in a proficient way is
also a reason for growth of private healthcare sector.
The trend of expenditure on capital formation by government sector
ranges from 10 to 14 percent of total healthcare expenditure in which
significant part is financed by donor funding. The trend of capital
expenditure in private sector is growing faster than in public sector. The
share of capital formation of the total private expenses was 15 to 31
percent between 2000 and 2010.

16. Year Capital Expenditure on Medical Equipments
(In SLR millions)
2005 1336
2006 2062
2007 2773
2008 3761
2009* 4204
2010* 7255
Budgetary allocation on capital formation in public sector
(Medical Equipments)

18. Estimated budgetary allocation on capital formation
0
1000
2000
3000
4000
5000
6000
7000
8000
1990 1995 2000 2005 2010
InSLR(million)
Year

19. Estimated budgetary allocation on capital formation in last 20 years
Year In SLR million
1990 194.04
1995 381.1
2000 781.62
2005 1558.7
2010 7255

20. The various mode of public procurement are-
a) International Competitive Bidding
b) Limited International Bidding.
c) National Competitive Bidding.
d) Direct Contract.
e) Shopping and
f) Emergency

21. The choice of procurement method depends on-
a) The nature of goods to be procured.
b) The value of procurement.
c) The local availability and cost of goods.
d) Critical dates of delivery.
e) Agreement with funding agency and
f) Transparency of procurement procedure.

22. The Medical Equipment Market in Sri Lanka is totally dependent
upon import. The Market in Sri Lanka is still in the budding stage,
i.e. the market for medical equipments is opening up. The demand
for these equipments and technologies has increased exponentially
in the recent years.
Today the total medical equipment market is around 40 million USD.

23. Sri Lanka is one of those countries that permits the import of
refurbished medical equipments on the same terms as that of
new equipments are imported.
The refurbished medical equipment market share is two to five
percent of the total equipment market.
The refurbished market is exclusively operated in private sector,
i.e. public purchase of equipment is always for new medical
equipments through release of tenders.
The equipments mainly sold in this market are radiological
equipments, dental equipments etc.

24. Medical equipment market in Sri Lanka
Year Total Market Size
(USD mn)
Total Export (USD mn)
1996 22 22
1997 24 24
2001 23 23
2002 25 25
2003 28 28
2008 40 40

25. 0
10
20
30
40
1996 1997 2001 2002 2003 2008
USD(million)
Year

26. Pharmaceuticals, Drugs, Devices and Cosmetics need to be registered
with the CDDA of the Ministry of Health (MoH) of Sri Lanka. Only
products registered to CDDA can be manufactured, imported, transported,
and sold in the country.
Every foreign manufacturer/Exporter has to appoint a local agent in Sri
Lanka. The local agent on behalf of the company is responsible for
registration and other activities related to their products in Sri Lanka.
The registration of Cosmetic, Devices and Drugs are governed by the
CDD Act of 1980 and regulation thereto of 1985 and the subsequent
amendments. This act is administered by the Director General of Health
Services who is the authority for the act (CDDA).

27. Registration of Medical Equipments to the CDDA Sri Lanka is a
two phase process. In the 1st phase a temporary license is issued
for a period of one year. In the 2nd phase a permanent license is
issued.
First Phase (Issue of Temporary License):
The applicant (Local Distributor/Agent) applies for the
registration of particular medical device to the Office of
D/MT&S. The documents required are as follows-

28. 1. Form-A of Schedule I.
2. Form-B of Schedule I (three copies).
3. Regulatory Approval from any Developed Countries Regulatory
Authority, like FDA, CE Marking, TGA, Health Canada.
4. Free Sale Certificate.
5. Certificate of Exportability.
6. Certificate from the Health Authorities of the country in which
it is produced, confirming that the device is in use there and the
period f use and if not, reasons for not marketing it in the country
of manufacture.

29. 7. Fully packed samples of the device in the form that will be offered
for, to enable study of the product.
8. Specimen Label and Package.
9. Technical Manual.
10. Instruction for use.
11. Fee receipt.

30. Second Phase (Issue of permanent license)
After completion of one year, the applicant apply for permanent
license.
The documents mostly required are-
1. Application form with a copy of registration license issued.
2. Record/data regarding the performance of the equipment.
3. Documents pertaining to its utilities and facilities.
On checking the authenticity of attached documents and if found of
the standards prescribed permanent license is issued for five
years.

31. The Atomic Energy Authority is the apex body on promotion of
peaceful application of nuclear technology. It is a statutory Body
which comes under the Ministry of Science and Technology.
The AEA is empowered by the Act, to regulate use, transport,
import, export and dispose of radioactive sources.
The application for authorization process to AEA Sri Lanka is
filed only after completion of registration to CDDA.

32. The registration/authorization of imaging diagnostic X-ray
equipments to AEA Sri Lanka is a is a three phase process.
The phases are-
1. Application for authorization to obtain import license- Form I-5
2. Application for authorization to import imaging diagnostic X-
ray equipments-Form I-1 and
3. Application for authorization to sell/hire/loan imaging
diagnostic X-ray equipments- Form J-1.
The entire process takes around two months.

33. Practices Type of
Apparat
us
Forms
Requir
ed
Fee per unit (in SLR)
(excluding import/export fee)
Diagnosti
c X-ray
Units
1.Dental
2.General
-Portable
-Mobile
-Fixed
3.CT and
Others
4.Fluoroscopy
5.Manography
Form I-
5
Form I-
1
Form J-
1
New
Appli
catio
n
With
15%
VAT
Renewa
l of
applicat
ion
With
15%
VAT
2500 2875 2500 2875
4700 5405 4700 5405
5900 6785 5900 6785
Forms and Fee Structure for obtaining authorization in each
category

34. The import and export process is mainly controlled by Custom
Department.
The documents required are-
1. Five copies of CusDec Form I and II (Form 53).
2. Commercial Invoice.
3. Delivery Order
4. Bill of lading

35. 5. Packing list
6. Catalogue/literature.
7. Certificate of Origin.
8. Import control license and
9. Exchange documents.

36. S. No. Type of charges Amount payable
01 Documentation fee 2.5 USD
02 Document processing fee 3.95 USD
03 GST 10.5% of consignment
04 SLPA 1000-2000 SLR (LCL)
2000-4000 SLR (FCL)
05 Excise duty Exempted
06 Cess Exempted
Various charges payable to custom on import

37. Parameters India Sri Lankan
Registration
requirement
for medical
equipments
to
Regulatory
Authorities
a. Process One step process Two step process
b. Regulatory Authority CDSCO and AERB CDDA and AEA
c. Application Form - 40 Form A and B of
Schedule- I
d. Registration granted. Form - 41 Form C of
Schedule-II
e. Fees 1500 USD for premises
and 1000 USD for
equipments
USD 250
f. Time length Six to nine months Four to six months
g. Validity Three years Five years

38. Registration to
Atomic Energy
Authorities
a. Authority AERB AEA
b. Applications AERB/445/MDX_Appform Form I-5
Form I-1
Form J-1
c. Registration fee Rs. 5,000 to 10,000 (depending
upon the type of equipment)
SLR 2,800 to 6,800
(depending upon the
type of equipment)
d. Time length _ 2-4 months
e. Validity 3 years 1 year

39. Import
registration
a. License
applicati
on
Form 8 and Form 9 Form – A of Schedule IV(for
devices other than imaging
diagnostic equipments); Form I-
1 for imaging equipments
b. License Form 10 Form – B of Schedule IV (for
devices other than imaging
equipments).
c. Fee USD 1,000 SLR 1,000