Who regulates medical devices in China?

The National Medical Products Administration (NMPA)
The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration or CFDA). The predecessor to the NMPA was initially founded in 1998 to oversee drugs and medical devices.

How are medical devices classified in China?

Specifically, devices in China are categorized into these classes:

1. China Medical Device Class I – medical devices for which routine administration is adequate for safety and effectiveness.
2. China Medical Device Class II – medical devices for which further control is required to ensure safety and effectiveness.

Does China have FDA regulations?

The National Medical Products Administration is directly under the State Council of the People’s Republic of China, which is in charge of comprehensive supervision on the safety management of food, health food and cosmetics and is the competent authority of drug regulation in mainland China.

What are the regulatory requirements for medical devices?

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:

• Establishment registration,
• Medical Device Listing,
• Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
• Investigational Device Exemption (IDE) for clinical studies.

What is CDE China?

NMPA’s Center for Drug Evaluation (CDE) is responsible for evaluating drug clinical trial applications, drug marketing authorization applications, supplementary applications, and overseas production drug re-registration applications.

How do I register a medical device in China?

For Class II and III devices: Following a successful review, NMPA issues registration certificate and posts online. Certificates are valid for five (5) years. You must place your NMPA license number on your device labeling, including IFU. You are now approved to sell in China.

How long do clinical trials take in China?

Conducting clinical trials in China is advantageous from regulatory perspective because ten months is the usual duration for the China State Food and Drug Administration (SFDA) to approve clinical trial applications (1). Regulatory reform in China has enhanced clinical trial review and approval.

How long does it take to get a drug approved in China?

FIGURE 2 | China Regulatory Reform Since 2015 In the past, it took two to three years for CTA approval. And now, by default, it is a 60 working day “silent approval,” meaning if no response is received in 60 working days the application is approved.

How does the FDA regulate medical devices?

To summarize, in the U.S. all medical devices are regulated by FDA A risk-basedregulatory paradigm is used to establish reasonable assurance of safety and effectiveness. The law gives us the flexibility to balance out our regulatory way of thinking to the level of potential risk posed by new products,…

What do medical devices require FDA approval?

The only products that the FDA specifically “approve” are drugs and life-threatening or life-sustaining “Class 3” medical technology . Scientific evidence from clinical trials must be provided by the manufacturers demonstrating the safety and effectiveness of their product.

What is the FDA equivalent in China?

The China Food and Drug Administration (CFDA), China’s equivalent of the FDA, has rolled back rules that were holding the sector back. Selling drugs owned by another company, and perhaps manufactured by a third, is standard practice for Western biopharmaceutical companies.

Do all medical devices need FDA approval?

FDA Approval for Medical Device. Generally, Class I and Class II medical devices do not require FDA approval, Most Class III device require FDA approval to market in the USA. Class II medical device require only a marketing clearance from FDA (510k) which is not an approval. Most class I device have only general controls.