How are medical devices regulated in China?

How are medical devices regulated in China?

First of all, China’s National Medical Products Administration (NMPA, formally CFDA) is responsible for the regulation of medical devices and drugs in China. Established in 1998, The CFDA oversaw medical devices, drugs and food (only after 2003). In March 2018, CFDA changed its name to NMPA.

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

It takes approximately 2-3 years to register a Class II or Class III medical device with the CFDA.

Which approval process is required for a Class III medical device?

Premarket Approval
Premarket Approval (PMA) Manufacturers of Class III devices (and devices that are not substantially equivalent to Class I or Class II) are required to submit a premarket approval application.

What are Class 3 medical devices examples?

Examples of the types of medical devices that fall under class III include:

• Cochlear implants.
• Implantable pacemaker pulse-generator.
• Renal stents.
• Wearable automated external defibrillators.
• High frequency ventilators.

What is NMPA approval?

China’s Pharmaceutical Regulatory Authority: The National Medical Products Administration (NMPA) formerly known as The Chinese Food & Drug Administration (CFDA) under the Ministry of Health (MOH) oversees all new drug registration approvals.

What is China PTR?

What is the China PTR? The Product Technical Requirements (PTR) are an appendix to the NMPA certificate for each product. It contains key details relating to the product and is the fundamental documentation throughout the registration process as well as for post-market sales support and ongoing regulatory requirements.

How long does NMPA approval take?

Per the DRR, the DAL, and the NMPA-No50-2018, a clinical trial application will be considered approved after 60 working days if the applicant does not receive a rejection or an inquiry for clarification from the NMPA.

Who regulates medical devices 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). The predecessor to the NMPA was initially founded in 1998 to oversee drugs and medical devices.

Is IVD FDA approved?

The FDA classifies medical devices, including IVD products, into Class I, II, or III according to the level of regulatory control that is necessary to reasonably assure safety and effectiveness. The classification of an IVD (or other medical device) determines the appropriate premarket process.

How long does PMA approval take?

According to a report from the agency, the average PMA application is approved 243 days post-submission. That’s just over eight months, or 66 days longer than the average time to approval for a 510(k) application.

What is a Class 3 medical device in China?

It is common to see that the classification system in China is stricter than that in Europe or in the US. There are some general including criteria for Class III device: Any implant device is class III. Any absorbable device is class III. Any device with ancillary medicinal substance is class III.

Are there any new medical devices approved in China?

In May 2019, the Chinese National Medical Products Authority (NMPA) published a new guidance document on the newly introduced electronic submission of approval documents (No. 29 and No. 46, 2019). Changes to an existing registration of domestic class III medical devices and foreign class II and III medical devices

Do you need CER for medical device in China?

*** The NMPA requires a Clinical Evaluation for all Class II and III 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.

Do you have to do clinical trials in China?

Again, Class I devices and most Class II devices do not require clinical trials. Class III devices are only exempt from clinical trials if they have been proven safe for use. All high-risk devices must be evaluated in China. Because of this, manufacturers who conduct clinical trials outside of China may be subject to review.