What is the China FDA called?
the National Medical Products Administration (NMPA)
Drugs and medical devices are overseen by the former China Food and Drug Administration (CFDA) now the National Medical Products Administration (NMPA), which reports to the State Administration of Market Regulation (SAMR).
What does CFDA stand for in China?
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).
What is CFDA registration?
Which regulatory bodies in the Chinese government are responsible for medical device registration in China? The China Food & Drug Administration (CFDA), now called the National Medical Products Administration (NMPA), is responsible for medical devices, drugs, and healthcare services.
Who is the regulatory authority of China?
The China Securities Regulatory Commission (CSRC) is a government ministry of the State Council of the People’s Republic of China (PRC)….China Securities Regulatory Commission.
| Agency overview | |
|---|---|
| Agency executive | Yi Huiman, Chairman |
| Parent agency | State Council |
| Website | CSRC.gov.cn |
When did CFDA change to Nmpa?
On 1 September 2018, the CFDA (China Federal Drug Administration) was replaced by the NMPA (National Medical Products Association).
Does China have food regulations?
In China, food quality and integrity is governed by the PRC Food Safety Law (2015) and its implementing regulations. The PRC Food Safety Law sets out comprehensive statutory requirements governing the production, circulation, recall and import/export of food products in China.
What is CFDA for medical devices?
CFDA defines an “in-vitro diagnostic medical device” as any medical device which is a reagent, reagent product kit, calibrator, or control material, whether used alone or in combination with an instrument, apparatus, equipment, or system, intended by the manufacturer to be used in vitro for the examination of specimens …
How do I register a medical device in China?
For Class II and III devices: Prepare registration dossier including testing reports, Agent authorization letter, CFS/CFG, clinical evaluation***, and other technical documents. All documents must be in Simplified Chinese. Submit to NMPA for review. Pay fees.
How do I register my medical device in China?
Submit to NMPA (no submission fees). All documents must be in Simplified Chinese. For Class II and III devices: Prepare registration dossier including testing reports, Agent authorization letter, CFS/CFG, clinical evaluation***, and other technical documents. All documents must be in Simplified Chinese.
Is there an SEC in China?
The China Securities Regulatory Commission (CSRC) is China’s regulatory body that oversees the securities industry in the country. The U.S. Securities and Exchange Commission (SEC) is the equivalent of the CSRC. The CSRC reports directly into China’s State Council, the main administrative body of China.
Are foods from China safe?
Most Chinese food imports are processed to some degree, and the most common problems cited by FDA—“filth”, unsafe additives, inadequate labeling, and lack of proper manufacturer registrations— are typically introduced during food processing and handling.
Does China require CE Mark for medical devices?
There is a list of exempted devices (Announcement No. 94/2018) that only require a simplified CER, while a full China Clinical Evaluation is required for all other devices. The China Clinical Evaluation is unique and requires comprehensive comparison to an equivalent product already approved in China, where available.
What is the SEC equivalent in China?
Key Takeaways. The China Securities Regulatory Commission (CSRC) is China’s regulatory body that oversees the securities industry in the country. The U.S. Securities and Exchange Commission (SEC) is the equivalent of the CSRC. The CSRC reports directly into China’s State Council, the main administrative body of China.
Is Nio stock delisting?
China’s EV darling Nio turns to Hong Kong and Singapore amid US delisting risk. Nio, an electric vehicle upstart from China, is planning to list its shares in Singapore, which will make the city-state the third base where it trades as geopolitical tensions between China and the U.S. heighten.
When did CFDA become Nmpa?
1 September 2018
On 1 September 2018, the CFDA (China Federal Drug Administration) was replaced by the NMPA (National Medical Products Association). While the two are not exactly the same (with some reorganisation having taken place), from the perspective of foreign companies wanting to work with Chinese CROs, little has changed.