Class II (Canada) generally corresponds to Class IIa (ECD) Class III (Canada) generally corresponds to Class IIb (ECD) Class IV (Canada) generally corresponds to Class III (ECD) Examples include surgical instruments (Class I), contact lenses and ultrasound scanners (Class II), orthopedic implants and hemodialysis machines (Class III), and cardiac pacemakers (Class IV). India Medical devices in India are regulated by Central Drugs Standard Control Organisation (CDSCO). Medical devices under the Medical Devices Rules, 2017 are classified as per Global Harmonization Task Force (GHTF) based on associated risks. The CDSCO classifications of medical devices govern alongside the regulatory approval and registration by the CDSCO is under the DCGI. Every single medical device in India pursues a regulatory framework that depends on the drug guidelines under the Drug and Cosmetics Act (1940) and the Drugs and Cosmetics runs under 1945. CDSCO classification for medical devices has a set of risk classifications for numerous products planned for notification and guidelines as medical devices. Iran Iran produces about 2,000 types of medical devices and medical supplies, such as appliances, dental supplies, disposable sterile medical items, laboratory machines, various biomaterials and dental implants. 400 Medical products are produced at the C and D risk class with all of them licensed by the Iranian Health Ministry in terms of safety and performance based on EU-standards. Some Iranian medical devices are produced according to the European Union standards. Some producers in Iran export medical devices and supplies which adhere to European Union standards to applicant countries, including 40 Asian and European countries. Some Iranian producers export their products to foreign countries. Standardization and regulatory concerns The ISO standards for medical devices are covered by ICS 11.100.20 and 11.040.01. The quality and risk management regarding the topic for regulatory purposes is convened by ISO 13485 and ISO 14971. ISO 13485:2016 is applicable to all providers and manufacturers of medical devices, components, contract services and distributors of medical devices. The standard is the basis for regulatory compliance in local markets, and most export markets. Additionally, ISO 9001:2008 sets precedence because it signifies that a company engages in the creation of new products. It requires that the development of manufactured products have an approval process and a set of rigorous quality standards and development records before the product is distributed. Further standards are IEC 60601-1 which is for electrical devices (mains-powered as well as battery powered), EN 45502-1 which is