China Regulatory Strategy Consulting

Regulatory has become an important and integral part of any medical business. Inefficient regulatory management can result in not only loss of opportunities in the market place, but also potential risks for noncompliance. A well-designed regulatory strategy enables a company to manage its activities effectively and avoid potential pitfalls in the future.

Whitney Consulting has guided many companies over the years to better plan and execute their China regulatory practice by providing critical guidance on regulations, compliance, and post-market supervision and problem solving. Combining years of expertise in regulatory business with on-the-ground experience dealing with real issues, Whitney provides clients with a clear understanding of the Chinese requirements and the ability to maneuver through the regulation maze.

Whitney Consulting is a full-service China regulatory consulting firm, offering services from clinical evaluation and product registration to post-market monitoring and regulatory reporting. We take care of each step of a project from beginning to end.

Compliance of Chinese IFU and Labeling

Similar to other countries, China has strict requirements for product labeling and Instruction for Use (IFU). The information in these documents has direct impact on business activities such as importation, sales, and compliance.

Whitney Consulting keeps clients in compliance with CFDA regulations for IFU and labels, and executes any amendments that need to be filed with CFDA when required.

Post Market Surveillance

As CFDA steps up monitoring activities for products on the market, post-market surveillance is emerging as a major regulatory topic for companies. Continuous compliance and supervision is critical to ensure continued business in China.

Whitney Consulting undertakes the responsibility of monitoring products sold in the Chinese market for its clients, responds to CFDA inquiries on product issues, and manages the AE evaluation, reporting, and re-registration activities on its client’s behalf.

Import and Export

Importation is a hurdle that every international company must overcome as they start their China business. Even after a few years of smooth imports, goods can still be held up at Chinese Customs due to newly imposed regulations or requirements. Understanding the importation requirements is the first step to ensure smooth entry into China.

In addition to importing challenges, exporting from China is just as problematic. Government regulations on taxes and fees can greatly impact the export process and costs.

Our company understands the import and export regulations and processes pertaining to different type of products and can negotiate with Customs agents on issues that regulations have not addressed. Whitney Consulting’s guidance is vital for clients seeking to build a sustainable channel for their products.

Medical Writing and Translations

We assist clients in drafting clinical evaluation reports and marketing and sales documents for the Chinese market. We translate technical, clinical documents for regulatory or sales needs. Our qualified reviewers are experienced with diverse products and are familiar with the lingo used in the medical field.

China Legal Representative

We act as legal representatives for our clients in China, managing their AE affairs and other regulatory issues. Whitney Consulting also acts in an advisory role, continuously providing our clients with the most up-to-date information.