International

Standards &
Certifications for
Medical Equipment
Introduction

Unlike drug regulation, which began in the late 1960s, medical device regulation is
a relatively new phenomena.

The Bureau of Medical Devices and Diagnostic Products was founded in the United
States in 1974, and Medical Device Amendments to the Food, Drug, and Cosmetic
Act were adopted in 1976 to ensure the safety and efficacy of medical devices.

In Europe, formal regulation of medical equipment did not begin until much later
(in the mid 1990s).
Cont…

Despite worldwide attempts to standardize medical device regulation through

organizations such as the Global Harmonization Task Force (GHTF), there remains a
significant disparity among regulators throughout the world.

The distinctions are in the idea, the classification of devices, the entire procedure,
the speed with which approvals are granted, their applicability across geographies,
and the cost associated.

Currently, the United States of America contributes for 38% of the medical device
industry, Europe 25%, and China 21%.
Regulatory Bodies Certifications in Developed
World
Sr. No. Name of Certifications Applicability
1 FDA United States of America & Mexico
Medical Devices Bureau of the Therapeutic Products
2 Canada
Directorate (TPD)
EU but approval by individual country still
3 CE (MDD)
required
4 Jp MHLW / PMDA Japan
5 CFDA China
6 Therapeutic Goods Administration (TGA)  Australia
New Zealand Medicines and Medical Devices Safety
7 New Zealand
Authority (MedSafe)
8 Korea Food and Drug Administration (KFDA) Korea
Federal Service for Surveillance in Healthcare
9 Russian
(Roszdravnadzor)
U.S. Food aand Drug Administration

The Food and Drug Administration is responsible for protecting the public health by
ensuring the safety, efficacy, and security of human and veterinary drugs, biological
products, and medical devices.

Class Risk Type Regulatory Control

I lowest risk  General Controls

General Controls with Exemptions and

II Medium Risk
without Exemption

II High Risk General Controls and Premarket Approval

CE (MDD)
Manufacturers must follow the requirements of the Medical Device Directive in
order to lawfully place medical device(s) on the European market. Before placing
the product(s) on the market, the applicant's product(s) and quality system must be
evaluated, and the manufacturer must apply the CE marking.
In accordance with the European Medical Device Directive 93/42/EEC.
Class Risk Type
I Low Risk 
Class Im (measuring device) Low Risk 
Class Is (sterile device) Low Risk 
Class IIa Medium risk
Class IIb Medium to high risk
Class III High risk
Jp MHLW / PMDA

Japan’s Ministry of Health, Labor and Welfare (MHLW) is the regulatory body that
oversees food and drugs in Japan, which includes creating and implementing safety
standards for medical devices and drugs. The PMDA works with the MHLW to
assess new product safety, develop comprehensive regulations, and monitor post-
market safety.

Class Risk Type

I Extremely Low Risk
II Low Risk 
Iii Medium Risk
Iv High Risk
Therapeutic Goods Administration (TGA) 

The Therapeutic Goods Administration (TGA) is the medicine and therapeutic

regulatory agency of the Australian Government. As part of the Department of
Health, the TGA regulates the quality, supply and advertising of medicines,
pathology devices, medical devices, blood products and most other therapeutics.

Class Level of Potential Harm

Class I Lowest
Class Is, Class Im Low
Class IIa Low to Moderate
Class IIb Moderate to High
Class III High
ISO 13485

• ISO 13485 is the quality management system specifically designed for medical
device manufacturers. It expands on and refines the framework established by ISO
9001, with the aim of harmonizing regulatory requirements. Compliance with ISO
13485 helps with overall quality control, traceability, process validation and risk
management.

• Manufacturers that attain ISO 13485 compliance will have an easier time bringing
their products to international markets. Compliance can also streamline your
processes and ultimately help you run a more efficient, profitable and risk-averse
operation.