Skip to main content

Registration Certificate (注册证)

A Chinese medical device registration certificate (医疗器械注册证) is issued by NMPA (or the provincial bureau for Class II domestic devices) upon successful registration. It is the authorisation to place the device on the Chinese market.

China-unique

Chinese registration certificates are valid for only 5 years and require full re-registration (重新注册) before expiry. This is different from, for example, FDA clearances (indefinite, unless recalled) or EU MDR certificates (up to 5 years, with some renewal). The hard expiry creates a significant ongoing compliance obligation.

What the certificate contains​

A standard registration certificate includes:

  • Device name (产品名称) and trade name
  • Model(s) and specification(s) (型号规格)
  • Intended use (适用范围)
  • Registrant name and address (注册人)
  • China Agent name and address (代理人) — for imported devices
  • Production address(es)
  • Registration number (注册证编号)
  • Date of issue and expiry date
  • Reference to the registered Product Technical Requirements (PTR)
  • Any conditions or special restrictions

Registration number format​

国械注准[year]XXXXXXX — national NMPA registration (Class III / imported) [Province code]械注准[year]XXXXXXX — provincial registration (Class II domestic) 国械注进[year]XXXXXXX — imported device (older format)

Changes requiring a supplement (变更申请)​

Not all changes require full re-registration. Changes are categorised as:

  • Registration change supplement (注册变更申请): significant changes requiring NMPA review (e.g. new models, manufacturing site change, intended use expansion)
  • Registrant filing change (备案变更): minor changes notified to NMPA without requiring approval (e.g. registrant address, contact details)

NMPA Order No. 47 and associated guidance specify which category applies to each type of change.

Re-registration (重新注册)​

A re-registration application must be submitted at least 6 months before the certificate expiry date. If the re-registration is not submitted or not approved before expiry, the certificate lapses and the device may no longer be legally sold. See Re-registration.

Disclaimer

Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official NMPA sources before making regulatory decisions. Not affiliated with NMPA or any Chinese Government body. Not legal or regulatory advice.