Medical Device
China
Localization

China Localization Models

China Localization General Process

Localization Mode	Self-Build	Acquisition	MAH
Legal entity in China
Factory construction
Design transformation	To be assessed
Sample trial production
NMPA registration-related research	To be assessed
NMPA on-site QMS inspection
NMPA registration approval
Production license

Domestic Medical Device NMPA Registration Process

China NMPA On-Site QMS Inspection for Domestic Medical Device Registration

Step 1Submit NMPA registration and receive acceptance
Step 2Submit request for inspection to local NMPA
Step 3Local NMPA perform onsite inspection
Three Possible Results
(1) Pass	(2) Pass with Rectification	(3) Not Pass
Report to NMPA	Submit rectification report within 1 month	Re-inspection after at least 3 months

Key documents required for domestic registration submission

Product risk analysis information.
Product technical requirements.
Product type testing reports.
Clinical evaluation information.
Product specifications and sample labels.
Product development, production-related quality management system documents.
Other information to prove product safety and effectiveness.

Notes: The domestic registration can leverage the previous registration dossier used for the imported registration, which may shorten the timeline for submission dossier preparation and NMPA technical review.

China Localization Webinar Videos

BradyKnows Service

China localization strategy

China NMPA registration

Medical device life-cycle regulatory compliance

Quality management system establishment and gap analysis

Quality management system mock audit

Medical device production license application

FAQ

While doing the domestic registration, can we use old type testing report used in the previous imported medical device registration?
Answer: No. You must complete the type testing for the domestic medical device manufactured in China.
When and how to apply for the production license?
Answer: Medical device manufacturer or entrusted manufacturer needs to apply for a medical device production license when the NMPA registration certificate is obtained. The production license shall be applied through the provincial regulatory authority for medical devices.
What kind of documents can be used from previous imported medical device registration dossier?
Answer: As per the NMPA Guidance document issued in 2929 (No. 104, 2020), the summary review documents, research documents, clinical evaluation documents, and risk assessment documents from the previously imported registration dossier can be used for domestic registration.
Which province or city is a good choice for the MAH model?
Shanghai is the first province in China to implement the MAH system and is currently the region with a complete system in the country.
According to the "Implementation Plan for the Pilot Program of the MAH in the Yangtze River Delta Region", if you establish a MAH in Shanghai, it can entrust companies in the administrative regions of Shanghai, Jiangsu Province, Anhui Province, and Zhejiang Province to carry out medical device production.
What are the requirements for basic personnel for the MAH?
In addition to the person in charge of the enterprise, there should be at least one person responsible for the quality system management (manager representative and quality person in charge), at least one regulatory affairs person (RA), and at least one post-marketing person (QA). The R&D process can be outsourced (Beijing and Shanghai have clear requirements). The product release process can be handled by the entrusted entity (as specified in the quality agreement), and the sales process can be entrusted to a suitable distribution company (in compliance with Good Supply Practices).

Medical Device China Localization