Global medical device regulations update - Journal of Pharmaceutical

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL SCIENCES

Shashikanth D, N. Vishal Gupta, Raghunandan H.V. Global medical device regulations update - A review. Journal of pharmaceutical and biomedical sciences (J Pharm Biomed Sci.) 2013 October; 35(35): 1774-1782.

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ISSN NO- 2230 – 7885 CODEN JPBSCT NLM Title: J Pharm Biomed Sci.

Shashikanth D, N. Vishal Gupta, Raghunandan H.V.

Review article Global medical device regulations update - A review Shashikanth D, N. Vishal Gupta*, Raghunandan H.V. Affiliation:Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS University, Sri Shivarathreeshwara Nagar, Mysore-570015, Karnataka, India. Tel.: +919242157508. Author’s contributions: - All the contributed equally to this paper. The name of the Department and Institution to which the work should be attributed:Pharmaceutics, JSS College of Pharmacy, JSS University, Sri Shivarathreeshwara Nagar, Mysore570015, Karnataka, India.

*Corresponding author:

Dr.Vishal Gupta. N, Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS University, Sri Shivarathreeshwara Nagar, Mysore-570015, Karnataka, India. Contact no. +919242157508.

Abstract: Background: During the 1960s, the Secretary of Health, Education, and Welfare (HEW) commissioned the Cooper Committee to study the adverse effects of medical devices for human use. In 1970, the study committee recommended a classification for medical devices based on comparative risk. In 1976, the Dalkon Shield intrauterine device injured s everal thousand women who aided the emphasis for regulatory oversight and therapeutic requirements provided by the U.S. legislation.

Aim: To Provide an overview of present Global Regulations on Medical devices Discussion: The medical device market changes frequently in terms of technology, risk potential, marketing and reimbursement. Therefore, it is imperative to be aware of existing requirements and new developments in the global medical device regulation. This Article reviews the lates t updates of M edical device regul ations i n different regulatory and non-regul atory bodies across the globe, which includes countries like Australia, Brazil, Canada, Chi na, Europe, and USA (United States of America) which are regulated and non regulated bodi es like India. Over 85 countries today regulate Medical Devices across the globe. Different regulatory bodies of respected nation provides regulations for placing medical devices in market and different quality systems and standards are involved in regulation of medical devices and also future developments in regulations on medical devices. Most of the countries hav e similar requi rements for registration of medical devices and are striving to harmonize with the GHTF guidelines (Global Harmonization Task Force). Conclusion: With the rapid growth in the global market for medical devices, there is a need to harmonize national standards in order to minimize regulatory barriers and to facilitate trade. Harmonization also reduces the cost of local industry, gov ernment regul ations & increases communication between the countri es to a better level.

Key Words: Medical devices; Quality systems ; Regulatory bodi es safety

Article citation:Shashikanth D, N. Vishal Gupta, Raghunandan H.V. Global medical device regulations update - A review. Journal of pharmaceutical and biomedical sciences (J Pharm Biomed Sci.) 2013 October; 35(35): 1774-1782. Available at http://www.jpbms.info

INTRODUCTION

A

Medical Device is any instrument/ implant/ appliance/ di agnostic aid used to treat, prevent and diagnos e the disease. Devices range from small syringes to highly 1774

sophisticated instruments like di agnostic X-ray instruments and MRI scanners 1. Medical Devices hav e been used since antiquity. As the regulations of Medical Devices involves well



defined and stringent regulations, which is often difficult for technical authoriti es involving different governing bodies of particular nation to govern the regulations. The M edical Device regulations are evolved as a result of “Thalidomide tragedy” in late 1960’s, moreover the regulations on Medical Devices has developed much more lately than that of medicines 2. High Quality and safe medical devices ensures trust and faith in public for the use of them. The knowl edge and compliance of devices with regulatory requirements is the key for success in globalisation of M edical Devices 2.

DISCUSSION The regulations of following countries are as follows: Australian medical device regulations: The Australian’s medical devices are regulated by TGA (Therapeutic Goods Administration), which is also a part of conformity assessment body for Australian’s manufacturers 3. Regulations: The current regulations are of Australian Regulations on Medical Devices, 2011, TGA, which are supported by many legislative standards & laws including animal tissue, sterilization which is originally EU derivative, 93/42/EEC3.

There are 3 committees, which provide advice on regulations, are3 1. Advisory Committee on Medical Devices (ACMD). 2. Therapeutic Goods Commi ttee (TGC). 3. National Coordinating Committee on Therapeutic Goods (NCCTG). TGA act-1989, bas ed on risk assessment approach, designed to ensure the devices are of acceptable quality, safety & efficacy in market. How devices are regulated? TGA is the division of Australian government department of health & ageing is res ponsible for regulating medicines and medical devices in Australia. The office of devices authorization is the region wi thin the TGA responsible for pre-market regulations of devices, while the post market regulations was controlled by office product Review (OPR)3. Life cycle approach to medical device regulations: The life cycle approach is detailed in the Table 1. Before any new device enters the market, the requirement, regulations of the particular device should meet the standards, which vary from device to device & risks associated with the devices are assessed, which also varies from little one to highly potenti al ones 3.The comparison of regulatory requirements v/s risks shown in following figure 1.

Table 1. Life cycle approach to medical device regulations Stage Required regulatory action Concept Prototype Preclinical Clinical Manufacturing Marketing

Supply

Obsolescence

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Consider the Essential Principles Incorporate the Essential Principles into the design Seek approval from or notify the TGA of intention to commence clinical trial  Follow clinical trial guidelines  Prepare clinical evaluation of clinical data Apply conformity assessment procedures and then obtain appropriate conformity assessment evidence Adhere to the Therapeutic Goods Advertising Code  Apply to include the device in the ARTG  Monitor safety and performance of the device during its lifetime  Maintain conformity assessment evidence  Report any problems with the device to the TGA and to the users of the device  Recall and/or correct devices that have defects, design flaws, or unacceptable clinical risks or levels of performance Notify the TGA so the device can be removed from the ARTG



Chart 1. Regulatory requirements v/s Risks3

Device classification: The levels of classification are given in Table 2. Table 2. Medical device classification by Australia 3. Classification Class I

Level of risk Low

Class I - supplied sterile Class I - incorporating a measuring function.

Low – medium

Class IIa

Low – medium

Class IIb

Medium – high

Class III

high risk

Active implantable medical devices (AIMD)

high risk

Registration & licences: The medical devices application in ARTG (Australian Regulations & Therapeutic Goods) submitted through eBS (eBS - Electronic Business Service), which has different levels of access of registered us ers & general public, some areas of eBS access res tricted by password3. Documentation: The Australian legislation require TGA to do an evaluation of conformi ty documentation which complies with essential principles for• Australian M anufacturers. • Specific high risk devices including materials of microbial or recombinant ori gin, derivatives of human blood/plasma 1776

Quality Systems invo lved: The standard for QMS (Quality Management System) is ISO 13408:2008, QMS audit for all classes except Class I (Non-sterile / without measuring function)3. Brazilian medical device regulations: ANVISA (Agência Nacional de Vigilânci a Sani tária), established in 1999 under Brazilian Ministry of Health is responsible for regulation of M edical Device and maintenance of registered product database in Brazil. Regulations of medical devices are through a seri es of resolutions / RDC’s, Resolution RDC No.185 of October 22, 2011 is the primary regulation of medical devices in Brazil for thei r registration4.



Classification of medical devices: Medical Devices classified in to distinct risk Classes (Class I, Class II, Class III, and Class IV) according to 18 rules; classification structure of medical devices corresponds to that used in EU (European Union) under council directive 93/42/EEC (European Economic Countries) of medical devices 4. Registration: The registration of most Class I & Class II devices involves a rel atively simple application process referred to as “Cadastro” meaning “Abbreviated registration” based on low to moderate risks associated with devices in these classes 5. Documentation: The documentation process is very compl ex, requires consulting various laws and decree (Law 6360:1976, RDC No.185:2001 & RDC No, 59:2000). GMP inspection & certification: Certification based on inspection done by ANVISA (RDC No.25, May 21, 2009), GM P certificate along with registration application for class of medical devices noted on exemption list (Instruction IN -2, June 6, 2011) should be provided during certification process 5,6 . Quality systems: It includes INMETRO (i.e., the National Institute of Metrology, Standardisation and Indus trial Quality) certification process 7. According to requirements of RDC No.27 & IN-3 published i n June 2011, all medical devices sold in Brazil fall under following standards and they must be standards of INMETRO certified6,7 . • • • • • • • • •

NBR IEC 60601 Seri es. NBR ISO 6875:1998: Dental chair. NBR ISO 7785-1:1999: Dental hand pieces Part 1: High speed air turbine hand pieces. NBR ISO 7785-2:2004: Dental hand pieces Part 2: Straight & geared angle hand pieces. NBR ISO 9680:2001: Dentistry – Operating lights. NBR ISO 9919:1997: Medical electrical equipment. NBR ISO 1195:2000: Gas mixers for medical use. NBR ISO 8835-2:2010: Inhalational anaesthetic systems. NBR IEC 61689:1998: Ultrasonicphysiotherapy systems.

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Canadian medical device regulations: Canadi an medical devices are regulated by Health Canada, Federal department, and Canadian medical device conformi ty assessment system (CMDCAS)8. Regulatory framewo rk: Health Canada, in co -action with s tandard council canada (SCC), helps CMDCAS to support medical device regulations to provide a framework to accredit CMDCAS Registrars. These registrars perform medical devices certification audi ts and provide CMD CAS certificate agains t ISO 13485:20038. Scope & classification of devices: Canadi an regulations include general medical devices, implantable devices, and IVD’s (In-vitro diagnostics). There are different rules for classification of medical devices & IVD’s, one set for medical device and one set for IVD’s. All medical devices are classified in four classes, which are class I, II, III & IV, based on their risk to human body 9. Canadian medical devices classification, determined by Canadian risk based classification system (RBCS) under auspices of Therapeutic product division (TPD) of Health Canada9. Distribution & technical documentation: Distributor selected for a nation should be provincial and with well-defined s trategies and resources in an i ncreasing competitive and changing Canadian market. All medical devices should need a technical documentation for their efficacy and safety issues 9. Quality systems: The Quality systems for medical devices is of registered Quality management system (QMS), which meets Canadian National Standard CAN/CSA ISO 13485:2003, modelled after ISO, Medical Devices: Quality Management Systems : Regulatory Purposes. QMS regul ations does not apply to Class I devices 10 . Licence & registration: The Medical devices distribution in Canada does not requi res local authorised representatives. If used need to hold Medical device establishment licence (MDEL) from Health Canada and those who are importing devices in Canada requi res regulatory appointment and use for licence and other regulatory issues. The market devices are shown in a Medical device active licence listing (MDALL) 11.



Current and future developments: The probability of changi ng medical device regulations is very less in near future, however Guidance Document GD 211 enforce specific requirements on audi t reports produced by CMDCA recognised registrars 12. China medical device regulations: State Food Drug Administration (SFDA) is responsible for medical device regulations in china13. Medical device classification: All medical devices are classified in four classes i.e.., Class I, II, III, IV and it covers general medical devices, active implantable devices and In-vi tro diagnostics (IVD’s) agents. Technical documentation: The medical devices must meet the Chi nese state standards or industrial product standards. Class II & III devices should include recent Type Tes t Report produced by medical device Quality testing agency recognised by SFDA13. Quality system: The devices should meet the requirements of regulations and quality standards. Each device requires SFDA certification, if not, for class II devices or parts, manufacturers needs to hold a valid YY/T0287-2003 (identical to ISO 13485:2003) certificate recognised by SFDA certified body. Forei gn manufacturers require accredited ISO 13485:2003 certificate for distribution of devices in market13. Distribution: All Class II/III devices require Medical device distribution enterprise licence (MDDEL). Devices to be sold in china must need a registration certificate and for forei gn manufacturers requi res SFDA approval via foreign manufacturer’s legal repres entative in china. The distributor or importer holdi ng Medical device distributing enterprise licence must be approved by provincial FDA14. European medical device regulations: There are three directives which govern the medical device regulations in EU are15: • Directive 90/385/EEC for Active Implantable Devices. • Directive 93/42/EEC for Medical Devices. • Directive 98/79/EC for In-vitro Diagnostic Devices.

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Directive 90/385/EEC for Active Implantable Devices: It is the firs t directive introduced in 1993, used to implant permanently in human body, has been significantly amended by Directive 2007/47/EC16. Classification of devices: This directive applies only to implantabl e devices, made a classification in to general, custom and non-custom devices. This classified devices strictly requires a clinical evaluation. It includes heart pacemakers, and other radioactive devices 2. Technical documentation: The technical documentation prepared by manufacturers should be in European language, supporting EU directive compliance. Manufacturers wish to get CE (certification) mark should follow this process for documentation as in EU directive5 . Quality systems involved: EN ISO 13485:2012 is standard for Quality system compliance under EU Directive 90/385/EEC15. Registration: AIMD’s (Active Impl antable Medical Devices) registration must be with the competent state authori ty of member state in which they are legally registered for business. Foreign manufacturers requi re an Authorised Representative (AR) wi thin EU member s tate to register15. Current & future developments: There is no extra requirement for recent ISO 13485:2012 standards, only change is table linking of this standard to AIMD 16. Directive 93/42/EEC for Medical Devices: This directive covers all medical devices, which are not included in other two directives. The requirements were amended significantly by Directive 2007/47/EC [16]. Classification of devices: It includes Class I, Class IIa, IIb, Class III devices. Generally devices included i n this directive require CE certification except custom medical devices, devices for clinical evaluation and systems / procedure packs 2. Quality systems involved involves EN ISO 13485:2012 harmonized standard under this directive.



Registration and licence: Class I devices are to be registered under this directive and licence is not requires for the devices under this directive15 .

Classification of in-vitro diagnostic (IVDD’s) devices: The classification of IVDD’s is given in the Table 3.

Directive 98/79/EC for in-vitro diagnostic devices: Since December 2003, this directive has become mandatory in EU. Table 3. Classification of IVDD’s 2,16 IVDD Type Conformity Assessment Option List A Annex IV or Annex V + Annex VII List B Annex IV or Annex V + Annex VI or Annex V +Annex VII Self-test Devices Annex III Section 6 List A – High Risk Devices (HIV kits), List B – Medium Risk Devices (Blood Glucose Meters), Self-test Devices (Pregnancy Test Kits).

Technical documentation: It should be in European language to support the compliance of their devices with the essential requirements of IVD directive. Risk Management and Clinical Ev aluation is mandatory for this documentation15. Quality systems involved: EN ISO 13485:2012 is standard for Quality system compliance under EU Directive 90/385/EEC13. Current & future developments : There is no extra requirement for recent ISO 13485:2012 standards, only change is table linking of this standard to AIMD. An amendment to CTS (Common Technical Specifications) was included to specifically include vCJD (Vari ant Creutzfeldt Jakob disease) in List A device classification2,13. Table 4. USFDA Classification 18 Device Examples Classification Class I Elastic bandages, examination gloves, and (High Risk) hand-held surgical instruments Class II Powdered wheel chairs, infusion pumps and (Medium Risk) surgical drapes Class III (Low Risk)

Heart valves, silicone gel filled breast implants and implanted cerebella stimulators.

USA medical device regulations: The regul ation on medical devices is controlled by US Food Drug Administration (US FDA). It was introduced in May 28, 1976 by Federal Food Drug and Cosmetic Act. It was implemented by Title 21 CFR (Code for Federal Regulations) parts 8001299, covers general medical devices and IVD’s 17. Scope & classification: According to US FDA, 21 CFR 862-892 the medical devices were classified in to different classes based on thei r level of control required to assure the s afety and effectiveness of the device. Medical Classification shown in Table 4.13

Safety/Effectiveness Controls General Controls. General Controls & Special Controls. General Controls & Premarket approvals.

Metal-on-metal hip joint, certain dental implants. General Controls Note: IDE – Investigational device exemption, PMA – Pre-market approval18

Routes for regulato ry approval: The FDA issues all the regulatory approvals required for medical devices and it depends on the class of device. It also specify the requirements like labelling and adverse ev ent reporting18. Class I exempt devices does not need any premarket notification or FD A clearance for sale in 1779

Required Submission Registration only, unless 510 (k) specified. -510 (k) clearance unless exempt. -IDE possible -PMA approval. -IDE possible. -510 (k) clearance.

the USA. Class I non-exempt, most of the Class II devices and some of the Class III devices require Premarket Notification 510(k) (21 CFR Part 807)18. Technical documentation: Premarket notification 510(k):



PMA (Pre-market Approval) is not requi red for Class I, II, and III devices propos ed for human use in US and submitting a 510(k) is mandatory to th e FDA by the manufacturers in order to place the device in the market13. Pre-market Approval (PMA): It is the FD A’s technical and regulatory review process to assess the s afety and efficacy of Class III medical devices. Cl ass III devices, which support or sustain human life, are of considerable importance in avoidi ng impairment of human heal th, or which pose a probable, unreasonable risk of disease or grievance13. Quality systems involved: 21 CFR Part 820 describes QMS and described as GMP, as it is not completely parallel with the requirements of ISO 13485:2003. An ISO 13485:2003 QMS s tates much of the GM P requirements and certification is considered beneficial and be able to be used as a part of the “Voluntary Audit Report Submission Pilot Program”18. Distributors, licence & registration: Before commercialising devices, all manufacturers must register for establishing and listing them, including contract manufacturers & sterilisers. FDA registration annually must be done by the manufacturers or workers of places of business, involved in the manufacture and delivery of medical devices intended for us e in the US market18. Current & future developments: Working with other GHTF (Global Harmonization Task Force) regulatory authorities (Canada,

Australia, Japan, and Europe) FDA, recently reduced the duplicate site audits. Combining CMDCAS and FDA i nspections allowing certain certification bodies by a pMAP program, Launched in 2012, the Voluntary Audit Report Submission Pilot Program allows to submi t ISO 13485 reports to the FDA, with defini te conditions by manufacturers 13. Indian medical device regulations: The Central Drug Standard Control Organization (CDSCO) in the Ministry of Health is principally accountabl e for regulation of drugs, medical devices, diagnos tic devices and cosmetics 19. Medicines and medical devices defined as drugs and are regul ated under the D & C Act 1940 and the D & C Rules 1945 and device registration is must prior to s ale in India19. Registration: The registration can be done according to Rule 24A of the D & C Act and Form 40 mus t be filed. The applicant may be the manufacturer, the trader or AR/agent in Indi a19. Classification of medical devices: Constant with GHTF control and the EU MDD, devices are classified as 20: • Class A (devices involving lowes t risk levels), • Class B (low to moderate risks), • Class C (moderate to high risks) and • Class D (highes t risks). The conformi ty evaluation necessities will be comparable to device classification, which is illustrated in following Table 5.

Table 5. The conformity evaluation necessities will be comparable to device classification20. Class A (I) Class B (IIa) Class C (IIb) Risk level Low Low-moderate Moderate-high Example Thermometers/ tongue Hypodermic Needles Lung ventilator / bone depressors / suction equipment fixation plate Certification by Notified body as part of Conformity Assessment ICAC marking Registration with CLAA Manufacturing License

Yes, for design and manufacture of medical device

Required Required

Yes, for manufacturing facility quality management system. Required Required

Class D (III) High Heart valves / implantable defibrillator. Yes, for the design and manufacture of medical devices.

Required Required

Required Required

Issued by State FDA

Issued by State FDA

Issued by State CLAA

Issued by State CLAA post join inspection by CLAA & State licencing authority

Not required. Sole responsibility of manufacturer

Technical documentation: The newes t document is the GD (Guidance Document) on Common 1780

Submission Format for Import Licence in Form 10 of Medical Devices in India. It pres ents the



submission leaflets for a medical device import license. Medicinal product import certificates are effective for three years after issued by govt. in India. Post marketing surveillance: The DCG (I) has stated that adv erse event and complaint reporting for medical devices is considered essential, and GHTF Study Group 2 guidance document “N 54”on Post Market Surveillance and Vigilance is under consideration for adoption20. Quality systems involved: Quality systems for medical devices does not exist, although CE-marked or FDA approved products are preferred because of their quality and performance. India will change near to the use of global standard ISO 13485: 2003, issued by the Bureau of Indian Standards (BIS) as Indian national standard IS 15579: 2005 21. Current & future developments: Presently MoHFW, DCG (I), Bureau of Indian Standards (BIS) and Nuclear Medicine Board of the Bhabha Atomic Regulatory Commission (BARC) regulate several aspects of the healthcare sector (including medical devices). As part of GOI’s efforts to advance a regulatory structure for medical devices, DCG (I) formed a minor “core group” of CD SCO officers and industry agents 21.

CONCLUSION With the rapid growth in the global market for medical devices, there is a need to harmonize national standards in order to minimize regulatory barriers and to facilitate trade. Harmonization also reduces the cost of local industry, government regulations & increases communication between the countries to a better level. ACKNOWLEDGEMENT The authors are thankful to JSS College of Pharmacy, JSS University, and Mysore for their valuable efforts in giving a platform to present our work.

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Shashikanth D, N. Vishal Gupta, Raghunandan H.V. 18.John J, Smith MD. Regulation of medical devices in radiology: current standards and future opportunities. Radiology 2001, Pageno-218,329-335. Available on: http://radiology.r sna.org/content/218/2/329.full.pdf 19.Dr B Hari Gopal, Draft Bill, The Medical Devices Regulation Bill, 2006 No XX of 2006, Advisor Department of Science & Technology Bhavan, New Mehrauli Road New Delhi – 110016. Available on: http://www.dst.gov.in/whats_new/whats_new07/MDRAAct.pdf 20.Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare, Govt. of India Guidance Document on Common

Submission Format for Manufacturing of Notified Medical Devices Under CLAA Scheme, Doc No: CDSCO/MD/GD/CLAA/01/00, Dated on: 31.10.2012, Effective Date from: 01st January 2013. Available on: http://cdsco.nic.in/Medical_div/Final%20Guidance_Doc_Form28_31-10-2012.pdf 21.Central Drugs Standard Control Organization (CDSCO), Medical Device Regulatory Profile for India, Directorate General of Health Services Ministry of Health and Family Welfare Government of India Nirman Bhavan, New Delhi -110011 Available on: http://cdsco.nic.in/FAQIMPORT%20&%20REGISTRATION%2 002022013_DONEE.pdf

Copyright © 2013 Shashikanth D, N. Vishal Gupta, Raghunandan H.V.. This is an open access article distributed under the Creative Commons Attribution Licens e, which p ermits u nrestricted use, distribution, a nd reproduction in any medium, provided the original work is properly cited.

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