Regulations and Standards for Medical Device

Regulations and Standards

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.

Testing according to applicable standards

Compliance to directives or norms can be fulfilled by showing compliance to various applicable national and international standards. Most of electro medical device must show compliance to IEC/EN 60601-1 series of standards. These requirements are almost common across the globe; In USA the same standard is adapted as national standard with country specific deviations and referred as ANSI UL 60601-1. Testing of medical devices in accrediated facilities is very important in the certification process. TUV Rheinland India has the necessary expertise and accredited test facilities for medical device testing (or medical testing) and certification.

The device must be in full compliance of all applicable requirements, according to harmonized list of standards and MDD. It is also important to see if any other applicable directive and standards are applicable. It is necessary to show compliance to all applicable standards and directives/norms before placing the product in the market.

Export

Export to Europe requires CE marking (precisely to European Union)
Export to USA requires FDA approval
Export to Canada requires Health Canada registration
Export to Japan requires PAL approval
Export to China needs SFDA approval
Export to Korea needs KFDA approval
Export to India needs CDSCO approvals

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Product Testing

Medical Devices