CFDA First On-Site Inspection for Oversea Manufacturers Lies Ahead

In order to strengthen the post marketing surveillance for imported medical device, CFDA recently will organize and conduct Production Quality Management System Inspection for some of oversea manufactures which sell their product in China. This oversea inspection will be the first time organized during these 15 years.

According to the Administrative Measures for Medical Device Registration, CFDA will organize and conduct GMP inspection while oversea manufacturers apply for registration for medical device of class II/III if necessary, this regulation came into force since 2000, but until now will be exactly implemented.

For the manufacturer who has obtained medical device registration certificate will be classified into Four grade based on Supervision and Administration Measures for Classification and Grading of Medical Device Manufacturer, and the frequency of inspection will be determined by the grade of manufacturer. For example, if your product with high risk listed in the National Catalogue of Key Regulatory Medical Devices, CFDA will conduct the GMP inspection least that once a year.

If you meet the following situations, CFDA will order you rectify and reform according to relevant regulations, or revoke the medical device registration certification for serious violators, as well as disapprove medical device registration application.
1.Produce medical device outside the product technical requirements;
2.Poor the production quality management system;
3.Reduce the production condition without authorization
4.Do not have the ability to conduct laws and regulations for medical device.

Who will be the top target in this oversea inspection?
CFDA has not yet released the list of inspection target and inspection timeline. But based on the past experiences of the oversea inspection for drug manufacturer, we can speculate those manufacturer which meet the following conditions will be the top target.

(1).For the manufacture which are applying for registration
Administrative Measures for Medical Device Registration has clearly demanded that the oversea manufacturer dealing with medical device of class II/III is required to be inspected if necessary.

(2).For the manufacturer which has obtain medical device registration

1.Medical device with high risk;
2.Medical device listed in National Catalogue of Key Regulatory Medical Devices;
3.Medical device with serious or large number of adverse events;
4.The manufacturer which issued Recall Notice frequently.

What the main problems will be faced in this oversea inspection?
The main purpose of this inspection is to check if the oversea manufacturers who export their product to China produce the medical device based on the requirements of Chinese GMP. However, many oversea manufacturers do not know relevant Chinese regulations and quality standards. Therefore, this is the leading problem for oversea manufacturer.

Hangzhou CIRS Co., Ltd can provide you the consultation services for GMP on-site inspection to help you deal with the oversea inspection.

The List of Relevant Regulations of GMP:

1.	Regulations for the Supervision and Administration of Medical Devices
2.	Administrative Measures for Medical Device Registration
3.	Administrative Measures for the Supervision of Medical Device Manufacturing
4.	Good Manufacturing Practice for Medical Devices
5.	Good Manufacturing Practice for Medical Devices Appendix for Sterile Medical Devices
6.	Good Manufacturing Practice for Medical Devices Appendix for Implantable Medical Devices
7.	Good Manufacturing Practice for Medical Devices Appendix for In Vitro Diagnosis Reagents

If you want to obtain the English Version of those regulations, please don’t hesitate to contact us. Or you can click here to know the Overview of Good Manufacturing Practice (GMP) for Medical Device

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