CFDA overseas inspection rapidly ramping up in numbers and expectations: are you prepared?

Most countries have enjoyed large gains in life expectancy over the past decades, thanks to advances in medicine. In China, life expectancy at birth has increased by more than 30 years since 1960, to reach 75.7 years in 2017. Today, China’s population is equivalent to 18.54% of the total world population, making it the most populated country in the world.

With China’s great population and advancement in the medical field, the Chinese market has become very competitive, as domestic manufacturers are also competing with foreign manufacturers to sell devices in their homeland, at typically lower cost.

To strengthen the post-market supervision activities for the protection of the Chinese population, the CFDA over the last 3 years has rapidly evolved and formalized their regulations for domestic and overseas manufacturers. The CFDA regulations have become more structured with more significant challenges to meet compared to many more familiar and recognized regulations in the medical device industry.  

Since 2015, the CFDA has annually conducted an increasing number of overseas inspections to EU and US manufacturers who market their products in China. CFDA conducts overseas inspections for new registration applications, non-conformance identified in import inspection, adverse event monitoring with complaints suggesting risk in quality and safety, major problems with other regulatory authorities, or re-inspection after corrective actions have been taken following an on-site inspection. Other circumstances could also bring CFDA to an overseas manufacturer including high volume sales of the manufacturer’ products in the Chinese market.

As the CFDA trains new inspectors on the GMP regulations (Order No. 64) and the Guidelines for On-site Inspection of the Implementation of GMP for Medical Devices SYJXJ 【2015】 No. 218, CFDA also has issued on December 28, 2017 a draft guide for comments from overseas manufacturers who are marketing or intending to market their medical devices in China. This guide intends to standardize the CFDA overseas inspection procedure and hopefully clarifies the inspection process for many foreign manufacturers’ struggling to prepare for CFDA inspections.

The following are few highlights of this draft guide: 
- Upon receipt of the CFDI (Center for Food and Drug Inspection) notification for overseas inspection, the manufacturer is to submit a Site Master File in both Chinese and English within 40 working days to the CFDI.

- The inspection will be conducted by no less than two inspectors. 
- The audit is conducted in Chinese. Importers are responsible for translation and verification of translation accuracy.
- Objective evidence can be obtained by photocopying, taking pictures, and other methods.
- Sampling might be obtained and mailed to China for conformity testing with the importers responsible to ensure that the packaging and transportation conditions for the samples meet the requirements without affecting the quality of the samples.

- Defects Identified in the Inspection are sent in an inspection finding report within 40 working days after inspection
- The comprehensive assessment conclusion may be "Pass", "Pass after Rectification" or "Fail". 
- The comprehensive assessment shall be judged as “Fail” where there are authenticity problems, inconsistency between the product quality and registration dossiers, serious defects, defects without proper rectification measures, infeasible rectification plan and others failing to meet the requirements in the laws and regulations as well as technical specifications identified in the on-site inspection.
- Uncooperative situations encountered during the inspection shall lead to a "Fail" conclusion.
- Classified handling can be in the form of a warning letter, suspension of the import of medical devices, suspension of sales and use, or disapproval of registration renewal.
- For those suspected of violations, CFDA shall investigate and deal with them in accordance with China’s laws.

With this draft of the overseas inspection guide, manufacturers may have some of their questions answered, but the language and cultural differences remain to be unresolved barriers to become well-prepared for the CFDA overseas inspections. 

If you have received a CFDI notification for an inspection and you require support or resources to help you become prepared, do not hesitate to contact Qserve’s team of CFDA experts.


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China is increasingly becoming an important playground for both domestic and international medical device manufacturers. Not only the medical device market is increasing in China, so is the complexity of the regulatory landscape.

Qserve can help you navigate through the Chinese market by offering a wide range of customized services, including building Regulatory strategy plan, Clinical AffairsCFDA China Agent (Qserve has a local entity in China (WFOE), CFDA registration or CRO services.  



Gert W. Bos, PhD, Fraps
Rania Gerges
Stephanie (Xing) Huang
Post date: July 09, 2018
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