Imported Device Registration Intake Levels and Review Workflow in China

1. Key takeaways

China routes every imported device through one national authority, making the timetable predictable but leaving little slack when a deficiency notice arrives.

• Imports go to NMPA whatever the class. Class I import filing and Class II and Class III import registration all go to NMPA under Article 8, paragraphs 5 and 6, unlike the domestic split by class.
• Technical review sits with CMDE. Article 5 assigns the Center for Medical Device Evaluation the review of import Class II and Class III applications, including variations and renewals.
• Review and approval are two statutory nodes: transfer to CMDE within 3 working days of acceptance (Regulations, Article 17, paragraph 2), and a decision within 20 working days of receiving the review opinion (Article 18, paragraph 1).
• Deficiencies carry three hard constraints: all deficiencies notified at once, everything supplied within 1 year, and termination with a refusal if it is not (Measures, Article 41).
• Class III devices requiring approval have a separate gate: a trial application is decided within 60 days of acceptance, deemed consented if no notice issues (Measures, Article 40); Article 27 of the Regulations sets 60 working days for Class III high-risk trial approval, also deemed consented.

In our assessment, the import route is central: one acceptance standard, no buffer in the deficiency window. Time management should shift from review duration to whether the correction package can be assembled in one pass within the year.

2. Legal basis

Medical Device Supervision and Administration Regulations (State Council Order No. 739, promulgated 9 February 2021, effective 1 June 2021)

• Article 16, paragraph 2: the overseas applicant for Class II and Class III devices submits registration materials and proof of overseas marketing through its designated China entity.
• Article 17, paragraph 2: materials are transferred to the technical review body within 3 working days of acceptance.
• Article 18, paragraph 1: a decision follows within 20 working days of receiving the review opinion; under paragraph 2 the certificate and annexes are published within 5 working days of the decision.
• Article 23, paragraph 2: classification confirmation is determined within 20 working days of acceptance.
• Article 27: approval of a Class III high-risk clinical trial is decided within 60 working days of acceptance, deemed consented if no notice issues.

Medical Device Registration and Filing Measures (SAMR Order No. 47, promulgated 26 August 2021, effective 1 October 2021)

• Article 5: CMDE conducts technical review for domestic Class III, import Class II and import Class III devices, including variations and renewals.
• Article 6: provincial authorities handle domestic Class II review and approval, and quality system inspections for domestic Class II and Class III devices.
• Article 8: domestic Class I filing is municipal, Class II provincial and Class III NMPA, while all import procedures go to NMPA.
• Article 19: products shall meet applicable mandatory standards, with an explanation where a standard does not apply.
• Articles 30 to 32: testing precedes application, samples must be representative, and a self-test or qualified laboratory report is acceptable.
• Articles 22 and 23: NMPA operates communication and expert consultation mechanisms.
• Article 38: approval-catalogue Class III devices need NMPA approval and use in qualified tertiary A hospitals.
• Article 40: a clinical trial application is decided within 60 days of acceptance, deemed consented if no notice issues.
• Article 41: CMDE notifies all deficiencies at once; the applicant supplies them in one submission within 1 year; otherwise review terminates with a refusal.

Practical estimate. No uniform number of working days is set for technical review of import Class II and Class III devices. Scheduling treats the 3 working days for transfer and 20 working days for decision as hard constraints, reserving review and deficiency time separately. Whether a quality system inspection occurs is left to review need under Article 17, paragraph 3.

3. Expert insights

The acceptance level differs between domestic and imported products. A domestic Class II device is a provincial matter while an imported Class II device is national, and quality system inspections for domestic Class II and III devices stay with provincial authorities, with no provincial step for imports.

The effect is one counterpart, NMPA and CMDE, with local variation and provincial guidance gone.

Review and approval are two measurable nodes. Staff transfer the file within 3 working days, technical review fills the interval, and the decision follows within 20 working days of the opinion. Separating them lets a company route questions to the right body. A third node follows: publication within 5 working days under Article 18, paragraph 2. Publication is not a condition of validity, but no claim of approval should precede it.

The deficiency mechanism is the largest schedule risk. Article 41 sets three linked constraints.

The halves are symmetrical: neither side proceeds in instalments. One year may not match the breadth demanded, since non-clinical re-testing, supplementary clinical evaluation, revised technical requirements and updated test reports can arrive together, and any item needing an overseas laboratory slot consumes months. Our rule is to find the longest path on receipt, start it that day and run the rest in parallel.

Series and parallel stages.

For Class III high-risk products the trial approval is a hard precondition, and its 60 working days do not overlap the registration review, so schedule it separately.

4. Practical recommendations

• Confirm the acceptance level first. Import Class I goes through filing and Class II and III through registration, all at NMPA; a wrong assumption forces the dossier to be rebuilt.
• Reserve time for classification confirmation. Where a product is not in the catalogue, obtain confirmation first, decided within 20 working days of acceptance.
• Manage the deficiency response as its own project. Identify the longest path on receipt, start it the same day, and plan backwards from the 1 year limit.
• Schedule Class III high-risk trial approval separately. Use 60 working days under Article 27 and 60 days under Article 40, stating both formulations in the file.
• Fix the testing route early. Decide between self-testing and a qualified laboratory under Article 32, and check sample representativeness under Articles 30 to 32.
• Build a compliant channel to CMDE. Use the Article 22 communication mechanism before applying, and assess expert consultation under Article 23.

5. Verification checklist

• □ The device class is confirmed; products outside the catalogue obtained confirmation within 20 working days.
• □ The accepting body is confirmed as NMPA for Class I import filing and Class II and III import registration.
• □ Technical review is confirmed as sitting with CMDE.
• □ A China entity is designated as agent, with an authorisation covering the whole cycle.
• □ Proof of marketing in the country of origin was handled under one of three scenarios, notarised and translated.
• □ For Class III high-risk devices, approval status is confirmed, or 60 working days elapsed without notice with written evidence.
• □ Trial sites are filed, and catalogue devices are used in qualified tertiary A hospitals (Article 38).
• □ Testing is complete, with report source and sample representativeness checked.
• □ Mandatory standards are listed item by item, with explanations where not applicable (Article 19).
• □ The deficiency mechanism is in the plan: one notification, one submission within 1 year, termination on expiry, explained in writing to the overseas team.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Chinese market. Our team acts as the in-China registration agent, coordinates import agent and distributor arrangements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com