Entering the Chinese Market: Medical Devices and Drugs (NMPA)

The NMPA is responsible for the licensing of medical devices and drugs in China. The regime varies with the risk class and clinical data from China may be required in the higher classes.

For foreign manufacturers a LEGAL AGENT established in China IS MANDATORY: the licence is administered through that agent and the agent holds the licence.

• Device description, classification and intended purpose
• The product technical requirements document
• A type test report (from an authorised laboratory in China)
• Clinical evaluation or clinical study data
• Quality management system records
• Authorised representative appointment documents
• Chinese labelling and user manual

1. 01Scope DeterminationIt is determined which legislation and marking scope the product falls under in the target market. This step defines the entire process; getting it wrong wastes all subsequent work.
2. 02Determining Applicable StandardsThe standards accepted by the market and any national deviations are identified. The same IEC standard may apply with different deviations in different markets.
3. 03Establishing the Test PlanIt is assessed which part of existing test reports will be accepted; missing tests are planned. A CB Scheme report, if available, reduces retesting.
4. 04Local Party and RegistrationIf the market requires an established representative, importer or applicant, this party is designated and the necessary registrations are made.
5. 05Tests and Technical FileTests are conducted and the technical file is prepared. Some markets require testing to be performed within their own country.
6. 06Certification or DeclarationDepending on the market's regime, a manufacturer's declaration is drawn up or a certificate is obtained from the authorised body; a factory audit is carried out if required.
7. 07Marking and LabellingThe mark and label are applied according to the market's format and language rules. The language requirement is checked at customs in most markets.
8. 08Shipment and CustomsIf a pre-shipment document is required, it is obtained; the document set to be presented at customs is completed.

• The licence is issued in the name of the local agent; a change of agent requires a process
• Clinical data from China may be required in the higher classes
• Type testing is carried out in an authorised laboratory in China
• The process is long; the timetable must be planned accordingly

1. 01Medical device registration and compulsory product certificationThese are two separate authorities and two separate pieces of legislation; device registration does not satisfy general product certification and the reverse is also true.
2. 02The Chinese arrangement and the MDRBoth rest on risk classification, but the expectation of local testing and local clinical data is markedly heavier here; EU certificates are not directly valid.
3. 03The difference between risk classesThe lowest class requires registration and the middle and high classes authority approval; determining the class is the first decision that sets the duration and cost of the process.
4. 04The legal agent and the distributorThe legal agent is the applicant and the authority's counterpart; a commercial distributorship does not satisfy that legal role.

There is no separate certification page for this mark; the scope and process are as described on this page. The roadmap specific to your product is provided in writing at the quote stage.

This section's content is being prepared. The roadmap specific to your product and target market at the quote stage in writing.