Current Status of the Regulation for Medical Devices

Indian Journal of Pharmaceutical Sciences 695 November December 2008 On October 6, 2005, the Government of India released the Gazette indicating sterile devices as drugs (F. No. 11014/2/2005DMS and PFA; Gazette No. 1077 dated October 6, 2005) under the sub-clause (iv) of clause (b) of section 3 of Drugs and Cosmetics Act 1940 (23 of 1946)1. Earlier as per the sub-clause (iv) of the clause (b) of section 3 of Drugs and Cosmetics Act 1940 (23 of 1946) the definition of drugs included the items such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals as may be speciÞ ed from time to time by the Central Government by notiÞ cation in the OfÞ cial Gazette, after consultation with the Board2. With this notiÞ cation various items have been speciÞ ed as drugs, as given in Table 1.

intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes like 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 and providing information for medical purposes by means of in vitro examination of specimens derived from the human body and does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but may be assisted in its function by such means 3 .
Medical devices are now a pervasive part of modern medical care.They are in many cases associated with quality of care.In some cases, the use of devices has certainly improved quality.In other cases, devices have associated with many problems.The approach to quality of devices has depended largely on regulation.According to global statistics, 85% of the medical devices are manufactured in the USA, in Japan and in European Union countries.That is the reason why it is matter of concerns to the American and European regulation systems 3 .
Like medicines and other health technologies, they are essential for patient care at the bedside, at the rural health clinics or at the large, specialized hospitals.Medical devices also add to the Þ nancial burden on the Government health sector.The medical devices market is showing a double-digit growth.The cardiac devices alone are growing at 20 per cent.In India, the growth of the market is estimated to be between 10-15 per cent.There is a clear indication that the penetration levels are higher in the country.This is because of affordability by patients, increased awareness on health care, improved hospital infrastructure and the increased disease patterns 4 .
The public expects that medical devices meet the highest safety standards.Realizing the importance of Pharmacovigilance, Ministry of Health and Family Welfare, Government of India, with WHO funding, initiated a country wide National Pharmacovigilance Program.Central Drugs Standard Control Organization (CDSCO), New Delhi, coordinates the program.The Honorable Minister of Health, Dr. Anbumani Ramadass at New Delhi, officially launched the program on November 23, 2004.CDSCO has established 2 zonal centres, 5 regional centres and 28 peripheral centres all over India 4 .

Classifi cation of medical devices from regulatory view point:
Medical devices may be classiÞ ed as per their medical utility or technical design and manufacturing aspects.However, regulatory authorities around the world have According to the Directive 93/42/CEE and the US regulation 21 CFR 820, in the USA, the procedure to obtain an accreditation depends on the classiÞ cation of the medical device.The marketing of a medical devices is a subject to the FDA controls and unless exempt require "A marketing clearance".Table 4 gives regulatory requirements in US for medical devices 6 .Australia registers for therapeutic goods in Australia has classiÞ ed the medical devices into Þ ve classes (Table 5).The placement of in vitro diagnostic medical devices in the new system is still under consideration.All classes are required to demonstrate conformity with safety and performance requirements.
Class IIa, IIb, III and Active implantable medical devices (AIMD) require quality systems veriÞ cation.Class III devices and AIMDs are subject to the most extensive pre-market assessments 7 .

Regulation of devices:
The approach to quality of devices depends largely on regulation.In addition, there are many problems in the interface between the machine and the user or the patient that are largely untouched by device regulation, and are considered in quality assurance programs.As essential as device regulation is, it is not sufÞ cient to assure quality.Education is particularly important in this area.Quality assurance programs need to be familiar with common problems with medical devices and how to approach them.
The regulation of medical devices is a vast and rapidly evolving field that is often complicated by legal technicalities.For example, legal terms and their meanings are sometimes non-uniform even within one regulatory system.Optimum safety and performance require among all involved in the life span of a medical device: the government, the manufacturer, the importer/vendor, the user and the public each has a speciÞ c role to play in this risk management.

Regulation of medical devices in some countries:
The regulations (or standards, or norms) are intended to protect the user against the risks associated with design, manufacture and packaging of medical devices.They differ from one country to another.
As a science-based regulatory agency, the US Food  The conformity assessment procedures can be carried out under the sole responsibility of the manufacturer (low potential risk), except for sterile devices or devices with a manufacturing function.In this case, the intervention of a notiÞ ed body is necessary.

Class IIa
The intervention of a notiÞ ed body is compulsory at the production stage.

Class IIb
The intervention of a notiÞ ed body is compulsory to control the design and the manufacture.

Class III
The intervention of a notiÞ ed body is compulsory to control the design and the manufacture.An explicit prior authorization with regard to conformity is also required.The Australian medical devices industry plays an important role in Australia's health sector.Australia is among the world leaders in ensuring high standard international regulation and is one of the Þ ve members of the Global Harmonization Task Force (GHTF) for medical devices along with the US, Canada, the European Union and Japan.The GHTF publishes guidelines on basic regulatory practices, but there is nothing concerning the application of these guidelines and no proper inspection is carried out 3    They are generic standards, i.e. their requirements apply to any company, whatever the manufactured product or the delivered service.The ISO 9001 (2000) standard covers the whole system of activities starting from the conception until the sale of the article.It has become the international reference standard for the quality assurance system of medical devices, and even if it is not mandatory.It gets practically a legal force in Europe.Various bodies are appointed by each member state of the EU (Ministry of Health, Ministry of Industry and so on), which has to inform the European Commission, and the other member state of it.The European Commission publishes the list (regularly updated) of the notiÞ ed bodies, together with their identiÞ cation number (4 numbers following the CE marking) and the deÞ ned tasks for which they have been notiÞ ed.To carry out the certiÞ cation of conformity procedures, the manufacturer may apply to the notiÞ ed body of his choice in any EU country.
In practice, the quality level strongly varies from one notiÞ ed body to another 14 .
Developing countries usually do not have their own regulations on medical devices, but many of them refer to the European or American normative system, including GHTF to facilitate the sell of their products in Europe and USA.Since medical devices caused some accidents, sometimes fatal, their manufacturing process must comply with the Good Manufacturing Practices (GMP).There is a very strict quality assurance on all aspects of the production of the medical devices in order to protect the patient's health.In 1969 the GMP standards were drawn by the WHO for drugs, in 1976 it included regulation 21 CFR 211 on drugs in the USA, and in 1997 it included the regulation 21 CFR 820 on medical devices in the USA 6 .
In India the major source of pharmaceutical regulations is the Drugs and Cosmetics Act 1940.This legislation applies to the whole of India and for all products whether indigenous or imported.The legislation is enforced by the office of the Drugs Controller General of India (DCGI).However, at the field level, enforcement is done by the individual state Governments through their Food and Drug Control Administration (FDCA  15 .Indian drug prices are among the lowest in the world.India has recently being viewed as a place with great potential for clinical research.The pharmaceutical sector and especially the pharmacists have been playing a lead role in these directions.Medical device sector has so far not been even in the thought process of pharmaceutical sector.Pharmacy graduates or postgraduates are not even aware of aware of various medical devices used in hospitals.There are very few pharmaceutical companies that have taken a lead in medical devices (except syringes, medical gloves, bandages, condoms, contact lens, disinfectants, etc).Pharmacy personnel can certainly play an important role in the regulation of medical devices.Following are the steps needed to play a positive role in the reputation of medical devices though pharmacists 3 .
It is necessary to have proper understanding of medical device safety, risk involved, the degree of invasiveness, duration of contact, the body system affected, and local versus systemic effects.One should weigh the risks against the benefits to the patients compatible with a high level of protection of health and safety so that maximum beneÞ t and minimum risk is ensure when a device is being used by doctor.
Pharmacist should be actively involved in the regulation of effectiveness and performance of medical device.One has to provide clinically effective parameters through the manufacturer which are relative to the medical condition.Clinical effectiveness is a good indicator of device performance, which is closely linked to safety.
Pharmacists should be involved in the documentary of standards containing technical specifications or other precise criteria to be used consistently as rules, guidelines or deÞ nitions of characteristics, to ensure that materials, products, process and services are Þ t for their purpose.One has to ensure that the prescriptive, design, performance, and management speciÞ cations meet the standards.
Pharmacists can promote to establish voluntary standards by consensus from all interested parties (the stakeholders).The use of voluntary/consensus standards may be developed by experts with access to the vast resources available in the professional and industrial communities.Conformity to such standards can also be assessed by an accredited third party (such as a notiÞ ed body in Europe), and thereby improve and update the standards.All these can make medical device standards effective and efÞ cient tools for supporting health care, and provide to the manufacturers have the flexibility to choose appropriate standards or other means to demonstrate compliance with regulatory requirements.
Many countries lack access to high-quality devices and equipments that are appropriate for their speciÞ c epidemiological needs.This is particularly true in developing countries, where health technology assessments are rare and where little regulatory controls exist to prevent the import or use of substandard devices.With the vast majority of devices in developing countries being imported and this may increase the risk and need to be considered lives at risk.

CONCLUSIONS
In the era of newer research and development, technology may have both curse and bless for the lives of human beings.Hence, a proper and stringent rules and regulations need to be put forth in the practice.Different regulatory bodies exist that regulate or monitor the activities undergoing in terms of both socio-economic protection of human beings.Looking to scope and requirement of medical devices, India needs to enter in the global market to manufacture their own devices.Thus, a proper rules and regulations are needed to encourage the efÞ cient growth of device industry.
Rules and Regulations for medical devices are required in India.Since, the world market is seeing the accentuating use of medical devices in varied type of patients and with unique patterns of disease, this will not only give a public safety assurance but also the manufacturer will get a detailed, accurate, long term surveillance of the medical device, generating more information and hints for further improvements.
Education is particularly important in this area.Quality assurance programs need to be familiar with common problems with medical devices and how to approach them.

TABLE 2 : COMPREHENSIVE CLASSIFICATION OF MEDICAL DEVICES 3
*With or without GMP

TABLE 4 : REGULATORY REQUIREMENTS IN THE UNITED STATES FOR MEDICAL DEVICES 6
Most class I devices are exempted from clearance, but they are subject to the general control requirements Class II Most class II and some class I devices require a marketing clearance of which the obtaining is subject to the 510(k procedure.To get it, the manufacturer must submit to the FDA an information pack which shows that the proposed device is substantially equivalent to an already existing device on the American market.Class III Most class III devices and new devices require a marketing clearance of which the obtaining procedures (Pre-Market Approval [PMA] or Product Development Protocol [PDP]) are more stringent than the 510 (k).

TABLE 5 : CLASSIFICATION FOR MEDICAL DEVICES BY AUSTRALIAN REGISTER FOR THERAPEUTIC GOODS 7
These devices are non-invasive and simple or invasive and transient use/reusable, e.g., non-powered hospital furniture, some devices, classiÞ ed "listable" such as stethoscopes, examination gloves, dentures, wound dressings and simple surgical implements like non-sterile, non-powered surgical and dental instruments Class II Intermediate risk: Devices in this class are subdivided into Class IIa and Class IIb, depending on the level of invasiveness Class IIa devices are non-invasive for channeling or body ß uid modiÞ ers; special dressing; invasive and short term use; diagnostic active; device hospital and household/ commercial grade disinfectants, e.g., infusion tubing, polymer Þ lm dressing, urinary catheters, suture needles, hearing aids, dental Þ lling materials and oxygen meters Class IIb devices include 'healing' wound dressings; surgically invasive; implantable; active; contraceptives; blood bags, e.g., hemodialysers, insulin pens, bone cement, intra-ocular lenses, anaesthetic machines Class III High risk: These devices include the surgically invasive, including medicine and animal-derived products, e.g., all active implantable devices, cardiovascular catheters, absorbable sutures, heart valves and collagen implants AIMD Active implantable medical devices, equivalent to in risk to Class III ). Matters of product approval standards, clinical trials introduction of new drugs, and import license for new drugs are handled by the DCGI.With the help of Indian Council of Medical Research, New Delhi the approvals for setting up manufacturing facilities and obtaining license to sell and stock drugs are provided by the State Government.However, a similarly regulatory body for the Medical Devices rules and regulations is yet to be established properly.