Case Study 28 : Registration of Class II Medical Device in Australia, Brazil, China, India, Pakistan and Russia

Company Situation

The Client is a US based medical device company that has registered its class II medical devices in USA, Canada and EU. Client wanted to get approval for its products in international markets. Client’s expertise and geographical locations were limited to North America and was seeking a strategic partner to help expand its global market base.

GRP Solution

GRP’s team brings decades of experience with registration of medical devices worldwide across LATAM, Europe, Asia, Africa, Middle East and North America. GRP’s offices in these regions makes GRP standout as a partner of choice for devices companies seeking a Global Regulatory Partner. GRP conducted strategic workshops with Client’s commercial and regulatory teams to assess their commercial markets of priority and provide a regulatory landscape based on their current status of registration.
The strategy was based on device’s potential class in global markets of interest to develop a harmonized approach.

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More Resources:

China's NMPA

In China, the regulating Health Authority is  The National Medical Products Administration (NMPA) also formerly known as the China Food and Drug Administration or CFDA). The NMPA is a vice-ministerial-level administrative agency under the State Administration for Market Regulation (SAMR).

Brazil's Anvisa

In Brazil, the National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the regulatory agency that is responsible for the approval and supervision of medical devices,  pharmaceuticals, cosmetics and health services among others.

Australia's TGA

The Therapeutic Goods Administration 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.