Layout of starting the medical device business in India.

CONFIDENTIAL. INTERNAL USE ONLY. 0
Date : 27/06/2016
Layout of starting the medical
device business in India
Mayank Saini
Alere Medical Pvt. Ltd.

CONFIDENTIAL. INTERNAL USE ONLY.
Overview of Medical Device Industry
The Indian medical device sector is worth approximately USD 5.5 Billion and is
growing at 15% CAGR. The medical device market is dominated by imported
products, which comprise of around 75% of total sales. The domestic companies
are largely involved in manufacturing low-end products for local and as well as
international consumption. Lately, many multinational companies have
established local presence by acquiring established domestic companies or
starting a new business.
The regulatory framework in India applicable to medical devices is sadly
inadequate. At present, only 14 types of medical devices are regulated and rest
are unregulated. Some players enjoy absence of regulation while others frown
upon it. Various associations in the medical devices sector have lobbied hard for
introduction of a comprehensive regulatory regime and the government has
proposed a few changes. However, the proposals haven’t yet seen the light of the
day. Another peculiar feature of regulation in India is prohibition on advertisement
or promotion of medical devices claiming diagnosis/cure/mitigation of certain
notified diseases or ailments.
1

Key factors derived Medical Device Industries
The sector is at present growing at around 15% Compound Annual Growth Rate
(“CAGR”) for a plethora of reasons for strong growth prospects of the industry
are:
 Economic growth leading to higher disposable incomes
 Increased Public Spending in Healthcare
 Increased Penetration of Health Insurance
 Improving Medical infrastructure
 Increasing affordability due to growing income
 Increasing number of ailments
 Increasing demand due to “Medical tourism”
2

The major players in Indian market :-
 Hindustan Syringes & Medical Devices, Stryker, Baxter
 Opto Circuits (India), Boston Scientific
 GE Healthcare, BPL Healthcare India
 3 M, Trivitron Diagnostics
 India Medtronic, HD Medical Services (India)
 Johnson & Johnson, Abbott ,
 Becton Dickinson, Wipro Technologies
 HCL Technologies, Philips Medical
 Bausch & Lomb, Biopore Surgicals
 Baxter, Zimmer India, Accurex Biomedical
 Edwards Life Sciences, Eastern Medikit,
 St. Jude Medical, Endomed Technologies
 Alere Medical, SD Bio Sensor
3

Basic requirements to start the business of
Medical Device in India
 Manufacturing license (In case of “Manufacturing” setup)
 Import License (In case of “Trading” only)
 Warehouse license for storage and distribution
 Authorization of a person under D&C Act
 Factory License/Registration (In case of Manufacturing setup)
 VAT / CST registration
 Service Tax & Excise registration
 IEC code
 SVB registration
 Professional Tax management
 Income Tax – PAN/TDS
 Shops & Establishment (Office; Plant; Warehouse)
4

Definition of Medical Devices.
Medical device’ means any instrument, apparatus, machine, appliance, implant, in vitro
reagent , kit or calibrator, software, material or other similar or related article:
1. Intended by the manufacturer to be used, alone or in combination, for human beings for
one or more of the specific purpose(s) of:
 diagnosis, prevention, monitoring, treatment or alleviation of disease,
 diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
 investigation, replacement, modification, or support of the anatomy or of a physiological
process,
 supporting or sustaining life,
 control of conception,
 disinfection of medical devices,
 providing information for medical or diagnostic purposes by means of in vitro
examination of specimens derived from the human body;
2. Which does not achieve its primary intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its
intended function by such means.
5

List of “Notified Medical Devices”
6

Classification of IVDs in India
Currently in India CDSCO has classified the IVD kits in the
following manner.
7
Classification of IVDs
Notified IVD Devices
Non-Notified IVD
Devices
Non-
Critical
Semi
Critical

Further Classification of Notified & Non-Notified
IVDs
8
Notified
IVDs
1.IVD kits of HIV
2.IVD kits of HCV
3.IVD kits of HBsAg
Non-Notified
IVDs
Semi-critical
1.Cancer Markers
2.Dengue
3.Chikungunya
4.Malaria
5.Typhoid
6.Tuberculosis
Non-Critical
All In-vitro diagnostic Kits
and Reagents that are not
listed under
Notified/Critical IVDs and
Semi- Critical IVDs

Proposed Regulatory Classification Scheme under
Drugs and Cosmetics (Amendment) Bill, 2015.
Currently there is not a formal regulatory classification scheme, however,
draft regulations outline the following:
Class A – Low Risk (example: thermometers, tongue depressors)
Class B – Low-moderate Risk (example: hypodermic needles, suction
equipment)
Class C – Moderate-high risk (example: lung ventilator, bone fixation)
Class D – High Risk (example: heart valves, implantable devices)
9

Authorities
10
The Central Government and the State Governments are responsible for the
enforcement of the Act.
The Central Drugs Standard Control Organization (CDSCO), headed by the DCGI
is primarily responsible for coordinating the activities of the State Drugs Licensing
Authorities, formulating policies, and ensuring uniform implementation of the Act
throughout India.
The DCGI is responsible for handling matters of product approval and standards,
clinical trials, introduction of new medical devices, and import licenses for new
Notified Medical Devices.

Organogram

Licenses Required For Import, Sale, Manufacture and Loan of
Medical Devices Under the D&C Act 1940 and Rules 1945
12
Sr. No. License for or Registration Certificate Form
(Template) of
the License
Application
form
Relevant Rule Licensing
Authority
Timelines
1 Certificate of registration of the foreign
manufacturer and the medical devices to be
imported (Registration Certificate)
Form 41 Form 40 Rule 24-A Drugs Controller
General of India
(“DCGI”)
9 months
2 Import of Notified Medical Devices Form 10 Form 8 Rule 21 DCGI 3 months
3 Import of Notified Medical Devices for
examination, test or analysis
Form 11 Form 12 Rule 33 DCGI No time period
4 Permission to import new Notified Medical
Device for clinical trial or marketing
Form 45 Form 44 Rule 122-A DCGI No time period
5 Permission to conduct clinical trial using new
Notified Medical Device
Form 45 Form 44 Rule 122-DA DCGI Six months
6 Permission to manufacture/import new
Notified Medical Device after satisfactory
clinical trials
Form 45 Form 44 Rule 122 DCGI No time period
prescribed
7 Retail sale of Notified Medical Devices Form 21 Form 19 Rule 61(2) State Drug
Licensing
Authority
No time period
prescribed
The required licenses and permissions are described more specifically in the table below.

Cont.…
13
Sr. No. License for or Registration Certificate Form
(Template) of
the License
Application
form
Relevant Rule Licensing
Authority
Timelines
8 Whole sale of Notified Medical Devices Form 21-B Form 19 Rule 61(2) (Same) No time period
prescribed
9 License to manufacture Notified Medical
Devices
Form 28 Form 27 Rule 76 DCGI & State
Drug Licensing
Authority
No time period
10 License to manufacture a Notified Medical
Device for the purpose of examination, test or
analysis when no manufacturing license under
Form 28 is available.
Form 29 Form 30 Rule 89 State Drug
Licensing
Authority
No time period
prescribed
11 Loan License
(manufacture in facility owned by third party)
Form 28-A Form 27-A 76-A (Same as
above)
No time period
prescribed

Former List of Regulated Medical Devices in
India
14

A separate license is required for each manufacturing location and for each
Notified Medical Device at such manufacturing location. Under the Act,
“manufacturing” includes any process (or part) for making, altering, ornamenting,
finishing, packing, labeling, breaking up or otherwise treating or adopting any
drug with a view to its sale or distribution. However, “manufacturing” does not
include dispensing or packing at the retail sale level.
An application for Manufacturing License (Form 28) for medical devices has to be
made to the following bodies under CLAA Scheme:
The State Drugs Licensing Authority
The CDSCO zonal/sub-zonal office
The Drugs Controller General of India, CDSCO HQ
 For detail guideline and filing procedure please visit below web address.
http://www.slideshare.net/MayankSaini21/procedure-for-getting-the-
manufacturing-license-of-notified-ivds-products-in-india
15
Manufacturing of Notified Medical Device in India

Importing of Medical Device in India
Import of medical devices is regulated in India that any industry or an
individual having license (wholesale and/or manufacturing license) issued
under Central Drug Standard Control Organization (CDSCO), Drugs and
Cosmetics Act, 1940 and Rules 1945 can import medical devices into India.
An applicant can submit an application for Registration Certificate (Form 41)
and Import License (Form 10) together at the same time, on condition that
Indian agent and importer remain same .
Import of medical devices in India Requirements:
 Form 41 (Registration Certificate) is required as per requirements of
the Drugs & Cosmetic Act
 Wholesale Drug License in Form 20B & 21B
 The firm must be registered with the CDSCO SUGAM Online System
For detail guideline and procedure please visit below web address.
http://cdsco.nic.in/Medical_div/Final%20Guidance_Doc_Import_Licence_31.
10.2012.pdf
http://cdsco.nic.in/Medical_div/Final%20Guidance_Doc_RC_31-10-2012.pdf
16

Documents Required for Import of IVDs
Registration
17
Legal Documents
• Form-40
• POA
• DI
• DII
• Whole Sale Licence
(Form 20 B,21 B)
Regulatory
Documents
• Plant Registration Certificate
• Manufacturing & Marketing
Licence
• Free Sale Certificate from the
country of origin
• Free Sale Certificate from anyone
of the GHTF countries
• CE Declaration of Conformity
• CE Design Certificate
• CE full quality Assurance
• Copy of ISO/EN-13485
Certification
• List of countries where the device
is being sold
Technical
Documents
• Plant master file ( PMF)
• Device Master File ( DMF)
• Post Market Surveillance files

Documents Required for Import
Licence(Form 10)
18
Notified IVDs
• Covering Letter
• Form-9
• Form-8
• TR 6 Challan
• Wholesale or Manufacturing
Licence
• Registration Certificate.
• Labels
Non-Critical IVDs
• Covering Letter
• Form-9
• Form-8
• TR 6 Challan
• Free Sale Certificate
• Wholesale or Manufacturing
Licence
• ISO 13485
• Products Inserts, Labels,
COA
• Soft Copy of Products
Semi-Critical IVDs
• Performance Evaluation
Reports from National
Accredited Labs of India for
3 batches
• And all other documents as
Non-critical IVDs

19
INon/Semi Critical IVDs Critical IVDs
Appoint an India Authorized Agent who must have a
valid wholesale license (Forms 20B and 21B).
Grant Power of Attorney to your India Authorized
Agent to manage registration in India.
File application for Device Registration Certificate
to CDSCO using Form 40. Schedules D-1 and D-2
must be included, as well as verification of
compliance with US, Canadian, European,
Japanese or Australian regulations.
Device manufacturers new to India require a Form
45 (New Drug License) in support of the Form 40
application.
Obtain Registration Certificate Form 41 from
CDSCO. Certificate is valid for up to 3 years.
Basic Steps of Issuance of Import License

20
Identify distributor in India (holding forms 20B and 21B)
Continued..
Apply for Import License using Forms 8 and 9 with rest of documents mentioned
Obtain Import License (Form 10) from CDSCO. License valid for up to 3 years, or until the Registration
Certificate expires.
You are now authorized to market your IVD products in India.

Wholesale Drug License in India
Introduction
For a company/distributor/independent agent to be an Authorized Indian
Agent for a local / foreign manufacture at the Central Drugs Standard Control
Organization (CDSCO), they should hold a valid Wholesale Drug License in
Form 20B and 21B. The wholesale drug license is submitted to and granted
by individual State Licensing Authorities.
Some of the basic requirement for obtaining a wholesale drug license are,
 The office / shop area should be a minimum of 15 square meters.
 The office / shop must have refrigerator & air-conditioner on the premises.
 A Wholesale Drug License can be made under personal supervision of
the registered pharmacist / competent person. In some states, a
Wholesale Drug License is issued only to a company/entity who has a
person(s) with a degree or diploma in pharmacy from a recognized
institute/university.
 The pharmacist or a competent person should be a graduate with 1 year
experience in dealing in drugs or be S.S.L.C passed with 4 years’
experience in dealing in drugs.
 Once the Drug License is obtained, the same should be displayed clearly
on the premises for purpose of any future inspection.
21

Document Requirement for Wholesale Drug
License
The required documents can differ based on each state. However, below is the list of
generic document requirement for obtaining wholesale drug license in India.
Covering Letter stating the purpose of the application
Two applications in Form 19 with Declaration Form
Covering Letter stating the purpose of the application
Challan of fee
Blue print for the premises
Rental Agreement / Proof of Ownership of the premises
Property Tax Receipt
Incorporation Certificate / MOA / AOA / Partnership Deed
Board Resolution, in case of a private limited company
List of directors, in case of a private limited company
Affidavit and Biodata of registered pharmacist / competent person
Degree Certificates of the registered pharmacist / competent person
Appointment letter of registered pharmacist / competent person, if applicable.
Invoice receipt of the purchased Air-condition Refrigerator
22

Clinical Trials of Medical Devices/IVD’s
Clinical Trials in India: A detailed guideline for conducting clinical trials in
India with the phases of clinical trials are explained.
CDSCO regulates the clinical trials for drugs and medical devices in India.
Demonstration of safety and efficacy of the drug product for use in humans is
essential before the drug product can be approved for import or
manufacturing and marketing in the country. The Rules 122A, 122B and
122D, 122 DA, 122DAA, 122E of Drugs and Cosmetics Rules and Annexure
A, B, C and D of Schedule Y, describe the information/data required for
approval of clinical trials and/or to import or manufacture of new drug for
marketing in the country.
Document Requirements for Approval of Clinical Trials (Phase-I/II/III/IV).
For new drug substances discovered in India, clinical trials are required to be
carried out in India right from Phase I. For new drug substances discovered
in countries other than India, already conducted Phase I data is required
along with the application. After submission of Phase I data generated
outside India to the Licensing Authority, permission may be granted to repeat
Phase I trials and/or to conduct Phase II trials and subsequently conduct
Phase III trials.
23

For permission of such clinical trials the documents
required to be submitted are as follows
1. Form 44
2. Treasury Challan of INR 50,000 (for Phase-I)/ 25,000/-
(for Phase-II/III clinical trials).
3. Source of bulk drugs /raw materials.
4. Chemical and pharmaceutical information including: Information on
active ingredients: Data on Formulation:
5. Animal Pharmacology
6. Animal Toxicology
7. Human / Clinical pharmacology (Phase I)
8. Therapeutic exploratory trials (Phase II)
9. Therapeutic confirmatory trials (Phase III)
10. Special studies – Bio-availability / Bio-equivalence
11. Regulatory status in other countries
12. Prescribing information
13. Application in Form -12 along with T-Challan of requisite fees (in case of import of
investigational products)
24

Conducting Clinical Trials of Medical
Devices -- Updates
The Medical Device Advisory Committee (part of the CDSCO) is the key
approval committee for medical device clinical trials :
http://www.cdsco.nic.in/Forms/list.aspx?lid=176
 However, new regulations over the past two years have significantly
reduced the number of clinical trials in India and significantly increased
timelines to get your product onto the market.
 Strict rules on liability for death or injury to drug trial volunteers have
also been instituted.
 Compliance with good clinical practices (GCP) and adverse events
reporting regulations were also included.
 Organizations conducting pharmaceutical trials must set up audio and
video recording of the entire trial process.
 All stakeholders involved in a trial – such as ethics committees – must
also be registered and accredited.
25

Labelling Requirements for Registration of
Medical Devices in India
Medical Device manufacturers must follow the labelling requirements and must be
done on every medical device packaging. The CDSCO is the Indian FDA which
handles all regulations for medical devices in India. On 25th September, 2014 the
CDSCO issued amendments to the Drugs and Cosmetics Rules, 1945. An important
amendment for medical device manufacturers to observe is Rule 109A – labelling
requirements.
Medical devices which require registration in India include spinal needles, cochlear
implants, annuloplasty rings, tracheostomy tubes, syringes and needle, dental
implants, surgical sealants, heart valves, cardiac stents, orthopaedic implants,
endotracheal tubes, and catheters, among others. This article can help you
understand the labelling requirements for the registration of medical devices in India.
‘109A. Labelling of medical devices.– The CDSCO has issued guidelines for the
registration of medical devices in India. As per the updates, the following labelling
requirements have to followed and printed on the label or sticker. This labelling must
be done on every outer covering in which the medical device is packed.
26

Cont.…
1. Proper name of the medical device is required by the CDSCO;
2. The details necessary for the user to identify the device and its use;
3. The name of the manufacturer and address of the manufacturing premises where
the device has been manufactured is required by the CDSCO for the registration of
medical devices in India;
4. CDSCO requires the correct statement of the net quantity in terms of weight,
measure, volume, number of units, as the case may be, and the number of the
devices contained in the package shall be expressed in metric system; and the date of
manufacture and date of expiry; alternately the label shall bear the shelf life of the
product: (a) Provided that in the case of sterile devices the date of sterilization may be
given as date of the manufacture of the device (5) Provided further that the device is
made up of stable materials such as stainless steel or titanium, and supplied non-
sterile, date of expiry may not be necessary;
5. To provide, wherever required, an indication that the device contains medicinal or
biological substance;
6. To provide, a distinctive batch number or lot number preceded by the word “Lot No.”
or “Lot” or “Batch No.” or “B. No.”; (a) to indicate, wherever required, any special
storage or handling conditions applicable to the device; (b) to indicate, if the device is
supplied as a sterile product, its sterile state and the sterilisation method;
27

Cont.…
7. To give, if considered relevant, warnings or precautions for the attention of the user of the
medical device;
8. To label the device, if the device is intended for single use for the registration of medical
devices in India;
9. To overprint on the label of the container, the words “FOR CLINICAL INVESTIGATION
ONLY”, if the device is intended for clinical investigation;
10. To overprint on the label of the device, the words “Physician’s Sample—Not to be sold”,
if a medical device is intended for distribution to the medical professional as a free sample;
11. To provide, except for imported devices, the manufacturing licence number by preceding
the words “Manufacturing Licence Number” or “Mfg. Lic. No.” or “M. L”;
12. For the registration of medical devices in India, Devices or In-vitro diagnostics
which are not sold to customer or patient directly and are sold for use by hospitals or
diagnostic labs shall provide the information affixing additional label or sticker on outer
shelf pack;
13. To provide on the label, in case of imported devices, with the approval of the
licensing authority mentioned in rule 21, the import licence number, name and
address of the importer and address of the actual manufacturing premises, date of
manufacture, (if not already printed at the time of import) is required for the
registration of medical devices in India;
28

Cont.…
14. Provided that the label may bear symbols recognised by the Bureau of Indian
Standards or International Organisation for Standardisation (ISO) in lieu of text and
the device safety is not compromised by a lack of understanding on the part of the
user in case the meaning of the symbol is not obvious to the device user for the
registration of medical devices in India.
Custom Made Devices
For the registration of medical devices in India with the CDSCO, we can assist in
determining the requirements for custom vs general implants. When the device is
specifically made in accordance with a duly qualified medical practitioner’s written
prescription under his responsibility, in accordance with specific design characteristics
and is intended for the sole use of a particular patient and the label should bear the
word “custom made device. As per CDSCO requirements, Mass produced devices
which only need adoption to meet the specific requirements of the medical practitioner
or any other professional user shall not be considered to be custom made devices.
29

Authorization of a person under D&C Act
Authorization person will be responsible to make applications, for obtaining
registration or permission and also to make necessary applications, representations
that may be required in the ordinary course of business for the said purpose to various
bodies cover under D&C Act 1940 including the following authorities:
 Government of India
 State Governments and State Government Authorities
 The Municipal Corporation
 The Electricity Board
 The Postal & Telegraph, Telex, Telephones, Fax authorities, etc.
 Income Tax authorities
 Commercial Taxes Authorities
 Customs and Central Excise Authorities
 The Reserve Bank of India
 Office of the Directorate General of Foreign Trade and Custom
 Any other statutory Authority
Also he will be solely responsible for the conduct of day-to-day activities of the firm for
the purpose of Section 34 of the said Act as well as other prevailing enactments
established by Law of Government of India & shall abide by all the provisions of Drugs
& Cosmetics Act 1940 & Drugs Price Control Order 1995 as amended from time to
time.
30

Factory Licence
The factory owners are required to notify and also register their premises with the local
governing authority before the beginning of operations. This helps in facilitating the risk
management at workplace and the total implementation of Safety and Health Management
Systems in factory premises.
List of Documents required for factory license – 4 Sets – Duly Stamped and signed.
1. Brief Description of manufacturing process Flow Chart – on letter head
2. Form No. 1, 1A ,1B & Form No.- 2
3. Blue Print of the Building plan.
4. List of Product to be manufactured.
5. List of Machinery Hazardous involved in it and safety taken at site
6. Allotment Letter of plot / Occupation certificate & Lease Deed.
7. N.O.C. of Pollution (Exemption Letter)
8. List of Director of the company. & List of Directors approved by ROC
9. Copy of Board Resolution & Memorandum and Articles of the company
10. Cess draft copy & receiving copy or cess NOC
11. Form-11 copy & STR-4 Challan Copy
12. Sectioned Load copy of Electricity.
13. List of Worker with Father Name & Designation 31

Preparation of Building
plan by Architect as per
factory norms
Submission of
ApplicationDocument Preparation
Registration
Report
Submission
by the
Inspector
Query
Making the
necessary
changes in
the Building
Plan
Re-submission of Building
Plan
Building Plan
Approval
Submission of Fee online, calculation
based on the electricity load/ No. of
employees
Issuance of
Factory License
Brief Flow Chart of getting the Factory License
Inspection of
the factory by
IH & S (Labor
Department)
Query

Importer Exporter Code (IEC)
IEC Procedure and Documents Required :
IEC is a registration required for persons / entity / organization /
companies importing or exporting goods and services from India.
Directorate General of Foreign Trade under Ministry of Commerce and
Industry (DGFT) of India issues a 10 digit number called the IE Code.
An online application is submitted on the DGFT web site http://dgft.gov.in
were the individual/company has to apply in their respective zonal office.
The necessary supporting documents as per the Para 2.9 of Handbook of
Procedures of Vol I 2009-14 and fees should be made along with the
application. The timeline for obtaining the IE Code is 15 – 20 working
days post submissions.
Duplicate Copy of IEC Number:
Where an IE Code Number is lost or misplaced, the issuing authority may
consider requests for issue of a duplicate copy of IEC number, if
accompanied by a written statement confirmed by oath or affirmation.
33

Procedure for Application of IEC Code Number
Application procedure
In the link http://dgft.gov.in an application has to be submitted online at
(DGFT) duly filled in along with documents. Refer the Para 2.9 of
Handbook of Procedures of Vol I 2009-14 and fees.
Check List of Documents to apply for IE Code
1. Self-certified copy of PAN (Permanent Account Number) Issuing letter
or card issued by Income Tax Authority.
2. Two copies of passport size photos of the applicant duly attested by
the Banker of the applicant.
3. Registered post or challan/DD of Rs.100/- for speed post.
4. Scanned copy of Bank Certificate. This should be in .gif format
5. Scanned copy of applicant Photograph. This should be in .gif format
34

Cont…
6. For other mandatory documents format refer 2.9 of Vol I 2009-14 in
Handbook of Procedures of. These documents must be in pdf format
only.
7. Submitting online document must be in gif /pdf format should not
exceed 300 KB size.
8. Exporter must have an account for Net banking with one of the
following designated banks
9. All date should be entered in this DD.MM.YYYY format.
10. The scanned copy of RBI approval letter must be submitted if an
applicant is Nonresident Indian (NRI) and there is NRI interest in the
Firm/company and NRI investment with repatriation benefits in the firm
11. Before online submission applicant must ensure that the documents
attached are properly visible and complete otherwise application is likely
to be treated as incomplete.
35

Service Tax-CST-VAT
Governing act :
 Service Tax: is governed by Finance Act, 1994. It was then when the
finance minister brought in taxes on services rendered to reduce the
degree of intensity of taxation on manufacturing and trade without
forcing the government to compromise on the revenue needs. Service
tax does not have any specific act to govern its stipulations.
 VAT (Value Added Tax):is governed by respective state Acts. Every
state has a separate and distinct VAT act reserved for their state.
 CST (Central Sales Tax): is governed by Central Sales Tax Act, 1956.
This tax is governed by a single central act, though the chargeability is
state specific.
 When registered for VAT/CST, the manufacturer or trader is allotted a
unique 11 digit number which will serve as the VAT Number / TIN
Number / CST Number for the business
36

Registration under Act: When Compulsory?
 Service Tax registration is a function of gross turnover. Once the
turnover of the assessee crosses a threshold limit of Rs 9 lacs, the
service provider is required to get itself registered under the law, and
compulsorily required to charge service tax on services provided once
the turnover crosses Rs 10 lacs.
 VAT (Value Added Tax) registration is compulsory for dealers having
turnover exceeding Rs 5 lacs (or increased limit of Rs 10 lacs in some
states).On registration, such dealer is allotted a unique 11 digit TIN
(Taxpayer’s Identification Number).
 CST (Central Sales Tax) registration is not dependent on amount of
turnover. Simply put, registration of dealer becomes compulsory once
he affects an inter-state sale.
37

Difference of Taxability:
 Service Tax is a form of indirect tax imposed only on services provided.
From the point of view of a layman, providing services means assistance
in any work, taking up of any work on behalf of others, any professional
assignment or rendering intangible benefits to others.
 VAT (Value Added Tax) is a form of indirect tax imposed only on goods
sold within a particular state, which essentially means that the buyer and
the seller needs to be in the same state. Only when tangible goods and
products are sold, VAT can be imposed.
 CST (Central Sales Tax) is a form of indirect tax imposed only on goods
sold from one state to another state, which particularly takes into account
that the buyer and the seller needs to be in two different states.
 For detail guideline and filing procedure please visit below web address.
http://www.wbcomtax.nic.in/e-Services/User%20Manual%20for%20e-
Registration_04032014.pdf
38

Special Valuation Branch [SVB]
Special Valuation Branch is a Branch of the Custom House, specializing in
investigating the transactions involving relationship between the supplier and
the importer and certain other special features like Technical Collaboration
between the parties, etc. Special Valuation Branch examines the influence of
relationship on the invoice value of the imported goods in respect of
transactions between related parties. In respect of Technical Collaboration
Agreements and Joint Venture Agreements, the terms and conditions of
these agreements are examined to arrive at the conclusion, whether the
existence of such agreement has influenced the invoice value of the imports.
Special Valuation Branch is headed by a Deputy Commissioner of Customs
and assisted by one Appraising Officer and necessary Ministerial Staff and
Importers who are related to the supplier in terms of Rule 2(2) of the
Customs Valuation Rules, 1988 are required to register with SVB.
 For detail guideline and filing procedure please visit below web address
http://www.caclubindia.com/forum/files/3_special_valuation_branch_svb_.pdf
39

Income Tax-Pan Card
 Permanent Account Number (PAN) is a ten-digit alphanumeric number,
issued in the form of a laminated card, by the Income Tax Department, to
any “person” who applies for it or to whom the department allots the
number without an application.
 PAN enables the department to link all transactions of the “person” with
the department. These transactions include tax payments, TDS/TCS
credits, returns of income/wealth/gift/FBT, specified transactions,
correspondence, and so on. PAN, thus, acts as an identifier for the
“person” with the tax department.
 PAN was introduced to facilitates linking of various documents, including
payment of taxes, assessment, tax demand, tax arrears etc. relating to an
assesse, to facilitate easy retrieval of information and to facilitate
matching of information relating to investment, raising of loans and other
business activities of taxpayers collected through various sources, both
internal as well as external, for detecting and combating tax evasion and
widening of tax base.
 For detail guideline and filing procedure please visit below web address
http://www.indiacgny.org/pdf/PAN_FAQ.pdf
40

Proposed Legislations to Regulate Medical
Device Sector
41
There have been numerous proposals to introduce a comprehensive regulatory
regime that would be applicable all medical devices. A comprehensive
regulatory regime will be welcomed by the serious players as well as the
consumers as it brings regulatory certainty.
The Medical Devices Regulation Bill, 2006 was the first proposal that intended
to overhaul the regulatory framework for medical devices in India. It proposed to
adopt a broad and modern definition of medical devices and set up a separate
regulatory authority to oversee regulatory affairs of the medical device industry.
The proposal was, unfortunately, shelved.
In 2013, another proposal in the form of a Bill of Drugs and Cosmetics
(Amendment) Act, 2013 was made. This proposal was less ambitious as it did
not propose setting up a separate regulatory authority, but was step in the right
direction as it adopted the wide and modern definition proposed earlier, but with
notable additions such as medical device software.

Cont.….
Below, I have drawn a comparison between two proposals which were circulated to the
public for comments but could not be made into law.
42
Sr. No Medical Devices Regulation Bill, 2006 Drugs and Cosmetics (Amendment) Act, 2013
1. Proposal to establish a separate regulatory
authority called Medical Devices Regulatory
Authority
Proposal to establish a new authority called Central Drug
Authority that will regulate Medical Devices in addition to
Drugs Cosmetics. This is very similar to the present
regulatory regime.
2. Definition of manufacture broad Definition of manufacture broad, but does not include
customization for individual patients
3. Definition does not expressly include software Definition includes software
4. No industry representation on the advisory board
of the regulatory authority. Industry representation
in ‘technical committees’ which provides
recommendations for setting standards and
guidelines. Recommendations of the technical
committees are not binding.
Industry representation on the board of the regulatory
authority. Recommendations of the advisory board are
binding on the regulatory authority.
5. No power to regulatory authority to ban medical
device in public interest
Power to Central Government to ban medical device in
public interest

Cont.…
43
Sr. No Medical Devices Regulation Bill, 2006 Drugs and Cosmetics (Amendment) Act, 2013
6.
Proposed risk-based classification of medical
devices. Low risk devices to be marketed with self-
certification. High risk devices to be marketed after
obtaining conformity assessment
No risk-based classification proposed
7.
Proposed registration of both domestic and foreign
medical device manufacturers, including products
manufactured or imported.
No new registration requirement. Under existing law, foreign
manufacturers and imported products are required to be
registered with regulatory authority.
8.
Recognition to use of refurbished medical device No such express recognition. The draft amendment,
however, proposes to add refurbishing within the ambit of
‘manufacture’
9.
Proposal for establishment of Appellate Tribunal
comprising of experts to hear appeals from the
decisions of the regulatory authority
No separate appellate tribunal. Under existing regime, all
appeals are heard by the Minister/Secretary of the Central
Government/ State Government. The Minister/Secretary is
most often not an expert on the subject.

Recent changes made by CDSCO
 New labelling requirements under Standard of Weights and Measures
Act (SWM) require a 1-800 – or toll free telephone number for
complaint reporting
 Form 40, Form 41 have a reporting requirement
 Section 1.7 Safety and performance related information on the device
 7.10 Post-market surveillance data (vigilance report) are considered
seriously during the review process
44

Several Useful links for Medical Devices Business
 Frequently Asked Questions on Registration and Import of Medical Devices in
India
http://www.cdsco.nic.in/writereaddata/FAQ-IMPORT-&-REGISTRATION-
02022013_DONEE.pdf
 Frequently Asked Questions on Registration and Import of IVD’s Kits in India
http://www.cdsco.nic.in/writereaddata/Final%20FAQS-IVDnew.pdf
 Several CDSCO Notification and Guideline for Medical Devices and IVD’s Kits
http://www.cdsco.nic.in/forms/list.aspx?lid=1580&Id=1
 Online Application Submission System for various Licenses and certificate.
https://www.cdscoonline.gov.in/CDSCO/homepage
45

Layout of starting the medical device business in India.

Recomendados

Recomendados

Más contenido relacionado

La actualidad más candente

La actualidad más candente (20)

Destacado

Destacado (7)

Similar a Layout of starting the medical device business in India.

Similar a Layout of starting the medical device business in India. (20)

Último

Último (20)

Layout of starting the medical device business in India.