International Approval for Medical Devices

International approvals

The medical devices approvals/certification are treated differently in different countries and controlled by the local authorities. For example in European Union, requirements related to medical devices are illustrated in the form of directives. Medical devices, active implantable medical devices and in vitro diagnostic medical devices can be placed in European market only after, once they are CE marked. CE mark, can be achieved by showing compliance to the applicable directives of European Union. Similarly in USA, it is necessary to obtain the FDA clearance before placing medical devices into the market. In Canada, it is necessary to register certain medical devices with Health Canada before placing the devices in the market.

Various approvals required in various countries. Regulations are quite different from country to country and it is not necessary that all medical devices need approval in all countries. General certification procedures for medical devices are explained below.

  • Export to USA requires FDA approval
  • Export to Canada requires Health Canada registration
  • Export to Japan requires PAL approval
  • Export to Korea needs KFDA approval
  • Export to India needs CDSCO approvals
  • Export to Europe needs CE mark

Benefits at a Glance

With the support of TÜV Rheinland for approval of your medical devices, you:

  • Rely on one-stop-shop service from a single source.
  • Save time and money when you combine conformity assessment procedures with audits.
  • Benefit from quick turnaround times and our long-standing experience and expertise.
  • Have skilled contacts on site - always up-to-date on the latest developments.

Japan

Japan Regulation for Medical Devices
PAL- QMS / GMP Audit & Certifications for Japan
Manufacturer need to be in compliance with QMS/GMP Audit & the certification in accordance with MHLW ordinance No.169 (IEC 60601-1)

  • Local representative is essential
  • Labor and Welfare (MHLW)-the kyoka (license) & the shonin (Pre Market Approval)

Taiwan

The easiest way to approval in Taiwan is via the Technical Cooperation Program. As part of this program, during a regular audit of your quality management system for compliance with EN ISO 13485, TÜV Rheinland can check if your company meets Taiwanese GMP requirements. A positive audit report from us and the EN ISO 13485 certificate issued by us are required to apply for the "GMP compliance letter" required for approval of medical devices in Taiwan.

USA

US FDA (Food and Drug Administration) Approval
FDA approval enables medical deviceto sell in the United States
Medical device are regulated in the United States by the Center for Devices and Radiological Health (CDRH) of the FDA. The FDA/CDRH mandate is to promote and protect the public health by making safe and effective medical device available in a timely manner. The standard for demonstrating safety and effectiveness is determined in part by the risk associated with the device.

FDA 510 K Clearances or PMN
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k)

The purpose of a 510(k) submission is to demonstrate that a device is “substantially equivalent” to a predicate device (one that has been cleared by the FDA or marketed before 1976).  The 510(k) submitter compares and contrasts the subject and predicate devices, explaining why any differences between them should be acceptable. Human data are usually not required for a 510(k) submission; this decision is made at the discretion of the FDA. Laboratory testing is almost always a requirement. Depending on the type of 510(k), the law gives the FDA either 30 or 90 days to clear the device, ask questions, or reject the application.

Manufacturers may also submit a 510(k) if they alter their device. Not all changes require a 510(k) submission. In general, changes to a device’s intended use, contraindications, or basic operation require a new 510(k) clearance. Changes to blood-contacting materials, sterilization method, or performance specifications may also require a new 510(k). The FDA does not “approve” 510(k) submissions. It “clears” them. It is not legal to advertise a 510(k) cleared device as “FDA-approved.”

FDA PMA
A Pre Market Approval (PMA) submission is used to demonstrate to the FDA that a new or modified device is safe and effective. This standard is higher than is required for 510(k) submissions. Human use data from a formal clinical study is almost always required in addition to laboratory studies. The FDA is required to approve, question, or reject the application within 180 days. Changes to a PMA-approved device may require a PMA supplement or even a new PMA. Manufacturers have far less leeway in modifying PMA devices than they do for changes to 510(k) devices. PMA devices can be legally advertised as “PMA-approved” or “FDA-approved.”

Authorized third party reviewer for FDA 510K Approval
To improve the efficiency of the 510(k) process, the FDA created the Accredited Persons Program, which authorized third parties to conduct the primary review of 510(k)s for most eligible devices. As an Accredited Person, TUV Rheinland is able to review a manufacturer's 510(k) information and offer a recommendation to the FDA as to whether the device is substantially equivalent to other legally marketed devices (predicate devices) in the United States. The FDA will then determine whether to grant market clearance. TUV Rheinland is accredited to review 510(k)s for all devices eligible under the Accredited Persons Program.

Canada

Health Canada: Health Canada enables medical device to sell in Canada
Manufacturers selling class II, III and IV devices in Canada must be registered to ISO 13485 by a quality system registrar accredited under the Canadian Medical device Conformity Assessment Scheme (CMDCAS) and device license need to be obtained by health Canada

Health Canada registrars
TUV Rheinland is the organization accredited as management system certification bodies for medical device manufacturers and are recognized through Canadian Medical device Conformity Assessment System

Australia and New Zealand

Our experts would be happy to help you with your approval processes in Australia and New Zealand. The admission requirement is a Certificate of Conformity, CoC for short. Due to mutual contractual agreements, you can manage the required conformity assessment procedures in Europe. You then apply for authorization in the country you need.

Brazil

In Brazil, your medical devices need so-called "ANVISA product registrations." In addition, a mandatory certification system applies for electrical and medical devices, for which Brazil has adopted the series of standards of IEC 60601 as technical requirements. As an accredited body, we can issue the necessary permits for you.

TÜV Rheinland Brazil is accredited by INMETRO, the Brazilian accreditation body for system and product certification centers and can therefore issue the necessary permits.

Our Worldwide Accreditations

Japan

Authorization as an RCB, Registered Certification Body, for medical devices with medium risk

Taiwan

Authorization as a partner of the DOH, Department of Health, as part of the "Technical Cooperation Program," TCP for short

USA

  • Accredited by the U.S. Food and Drug Administration, FDA, for implementation of 510(k) for a large number of class II products
  • Approval for inspections in accordance with the US-EU Mutual Recognition Agreement, MRA for short, and the "Medical Device User Fee and Modernization Act"
  • Recognized as a Nationally Recognized Testing Laboratory, NRTL, in the U.S. and Canada

Canada

Admission as an official Canadian Medical Devices Conformity Assessment System Registrar, CMDCAS for short, with the Standards Council of Canada for certifying quality management systems in accordance with ISO 13485

Australia and New Zealand

Accredited Conformity Assessment Body, CAB, for approval of medical devices

Brazil

Accredited with INMETRO, the authority for system and product certification bodies

Russia

GOST R accredited certification body and as a GOST R laboratory