Registration Pathways

What is an imported medical device?

An imported medical device refers to any device manufactured outside mainland China and intended for marketing within the country.
It must be registered or filed in accordance with the Regulations on the Supervision and Administration of Medical Devices (State Council Decree No. 739), and relevant NMPA regulatory rules.
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Note: Imported Class I devices follow a filing process, while Class II and III devices require formal registration and technical review by CMDE.

NMPA

Filing vs. Registration

Filing:

For low-risk (Class I) devices – a simplified notification procedure

Registration:

For medium- and high-risk (Class II & III) devices – full evaluation required

Who can apply?

Overseas manufacturers must appoint a China-based legal agent to handle registration, submission, and communication with authorities.

How to Submit Registration or Filing Documents for Imported Medical Devices?
To market a medical device in China, the product must be:
Defined as a medical device under Chinese regulations, in line with the Regulations on the Supervision and Administration of Medical Devices (Decree No. 739), and Manufactured outside of mainland China, intended for import.

Required Documentation

If the product is already classified as a medical device in the country of origin:
The applicant must provide:
● A marketing authorization certificate or equivalent proof of legal sale in the originating country
● A manufacturer’s qualification certificate, proving compliance with GMP or QMS (e.g., ISO 13485)

If the product is not considered a medical device overseas, but is classified as one in China:
The applicant must provide:
● A declaration letter stating the product is not regulated as a medical device abroad
● Relevant technical documentation and proof of legal marketing (as applicable)

Registration Pathways

Registration/Filing Pathways by Class

Device Class	Submission Type	Technical Review Body	Notes
Class I	Filing with NMPA	NMPA completeness check only	Simple administrative review
Class II	Full registration	CMDE technical + NMPA admin	PTR, testing, CER usually required
Class III	Full registration	CMDE technical + NMPA admin	Higher scrutiny, clinical data essential