Medical Device Standards & Regulatory Bodies

Have you noticed these Symbols on Medical Equipments ? They indicate the Certification of Regulatory bodies of the country and Symbols of Standards they follow.

The medical device industry, with products ranging from implantable cardiac pacemakers to wheelchairs, and from diagnostic test systems to syringes and needles, are both rapidly evolving and highly regulated. International Standards play an important role in allowing the rapid introduction of new medical device technology while meeting the expectations of the public and regulators that medical devices are safe to use, perform as intended and offer benefits to patients that outweigh the risks.

The International Medical Device Regulators Forum (IMDRF) is an organization of national regulatory authorities dedicated for promoting international convergence of regulatory requirements and practices. In particular, the IMDRF aims to promote harmonized regulation of the safety, performance, effectiveness and quality of medical devices and to serve as an information exchange through which countries with medical device regulatory systems under development can beneﬁt from the experience of those countries with established systems.

Close cooperation between IEC, ISO, WHO and international regulatory harmonization initiatives to develop practical, effective and compliant medical device standards.

International Electrotechnical Commission

A Major Organisation setting standards in Medical Device Safety and Performance. The International Electrotechnical Commission is an international standards organisation that prepares and publishes international standards for all electrical, electronic and related technologies – collectively known as "electrotechnology"

Many national regulatory authorities actively participate in the development of IEC and ISO International Standards by contributing experts appointed through their national member body. These experts directly represent the viewpoints of their national or regional regulatory authorities and ensure the standards will meet the needs of countries across diverse geographies, cultures and economies.

IEC Standards for Medical Devices : IEC60601-1, IEC62353, IEC6060-2-2, etc.

ISO Standards

The International Organization for Standardization is an international standard-setting body composed of representatives from various national standards organizations. ISO standards accounted for the organization's quality management system by monitoring, maintaining and controlling the processes. There are Various standards established for Medical Device Manufacturing Facilities, Environmental Safety, Product Quality, Post Market requirements, etc.

• ISO 13485 is widely accepted for establishing conformity with quality system requirements to demonstrate the consistent delivery of the medical device that has been approved by the regulatory authority.

• ISO 10993 series are the global standards for demonstrating the biological safety and compatibility of materials used in medical devices with human tissue.

• The sterilization standards developed by ISO/TC 198 are utilized globally for ensuring the sterility of health care products.

• ISO 14971, which was jointly produced by ISO TC 210 and IEC SC 62A has become the benchmark for a medical device risk management process.

Regulatory Bodies

Various Countries had formed Regulatory Bodies and regulatory bodies established Policies (Directives) for Design and Development, Production and Distribution of Medical Devices in their Country. Example FDA by USA, CE byEuropean, CFDA by China etc. These regulatory bodies introduced directives adopted Standards from IEC, ISO, additionally they have implement special requirements for their country. Regulatory body for each country also classified medical devices based on the Risk Categories. IEC Classification of Medical Equipment is Classs I, Class II, Class II, while CDSCO(India) classified Equipments as Class A, Class B, Class C and Class D. Product companies need to get approval from regulatory body of each country to place the Product in their Market.

Regulatory Certifications displayed on a Product Brochure & Symbols on Product

Notified Body

Medical Device Companies requires to Develop Products as per Safety and Performance criteria of IEC, ISO and Regulatory Body of the specific country. They need to submit applications with sufficient documentations to Regulatory Body for the approval. The Applications to specific Regulatory body is processed through notified bodies like TUV, SGS, etc.

A notified body is an organisation designated by Regulatory Body of the country to assess the conformity. These bodies carry out tasks related to conformity assessment procedures set out in the applicable legislation, when a third party is required.

World Major Regulatory Bodies

When you buy a new Phone, or a TV or even a Toy you can see CE Mark. This Indicates CE is widely accepted standard. In Medical Device Segment CE and US FDA are considered as top level of Certification and Many countries adopted policies of CE.

Europe - CE marking is a certification mark that indicates conformity with health, safety and environmental protection standards for products sold within the European Economic Area.

United States - U.S. Food and Drug Administration (FDA)

China - China Food and Drug Administration External Link Disclaimer (CFDA)

India - Central Drug Standards Control Organization (CDSCO)

CDSCO is India’s main regulatory body for pharmaceuticals and medical devices.

In 2017, the Indian medical regulatory system has established. Past years no certifications were required for distribution of Medical Devices in India. These many years our Hospitals, Purchase Managers, Doctors and Biomedical Engineers have purchased Medical devices with Certifications of CE, FDA or no certifications.

Presently CDSCO classified medical devices as Class A, Class B, Class C and Class D based on their risk category. A CDSCO approved Medical Device with Class A Label indicate low risk category. CDSCO adopted directives in standards like IEC, CE, ISO Standards.

Regulatory Bodies : Other Countries

• Australia - Therapeutic Goods Administration External Link Disclaimer

• Brazil - National Health Surveillance Agency (ANVISA) External Link Disclaimer

• Canada - Health Canada External Link Disclaimer

• China - China Food and Drug Administration External Link Disclaimer

• Japan - Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour and Welfare External Link Disclaimer

• Russia - Russian Ministry of Health External Link Disclaimer

• Singapore - Health Sciences Authority External Link Disclaimer

• South Korea - Ministry of Food and Drug Safety External Link Disclaimer

Opportunities for Biomedical Engineers in Medical Device Regulatory Industry?

There are several levels of Opportunities in Medical Device regulation and quality Management. Some of the Jobs are meant for Technical Documentation development verification and filing , while some other give opportunities in Technical Areas of R&D and Product Development .

1.Third Party Companies / Agencies

Companies like TATA Elxsi, HCL, Accenture, are major employers in this segment. There are many other Small companies having 20 - 100 Employees. These companies are facilitating Document verification,Application Filing, Audit, quality management services etc. for Medical Device Companies.

Jobs in this area can be similar to a IT/BPO (Business process outsourcing) in Medical Device Regulatory segment. They have attractive starting pay scale for freshers which range from Rs.15,000 - 25,000 per month.

2. Medical Device Companies

If you are working in R&D department of a Medical Device company, you need to have in-depth knowledge in Product Development Standards by IEC and regulatory body directives. You should be able to work closely with Hardware Designers, Software Engineers, Mechanical designers, etc which means you need to have a expertise in Medical Technology, Product Testing area etc, to ensure Equipments are being developed as per the standards.

How can you get Employed in this Area?