Navigating the NMPA Registration Process: Timelines, Costs, and Considerations

Submitting your medical device registration to China’s National Medical Products Administration (NMPA) is a high-stakes moment. Your In-country representative plays a key role - not only handling the submission, but also acting as your direct liaison with regulators.

Medical device registration in China can be completed through the NMPA's electronic Registration Platform System (eRPS), via in-person submission, or by postal mail. Let’s go through the registration process, including review timelines, associated costs, and certificate validity based on risk classification.

Registration Process

The registration journey consists of multiple phases, including documentation preparation, application submission, technical reviews, and final approval.

Medical device registration in China follows a structured process involving multiple steps:

1. Structure of regulatory strategy - Evaluation of risk class, category, and clinical pathway applicable for your product

2. Registration testing - Perform a self-testing or entrust an accredited laboratory to test according to Product Technical Requirements (PTR) to verify the safety and effectiveness of the product

3. Document Preparation - Compilation and preparation of product-relevant dossiers, clinical evaluation data (e.g. predicate selection and literature search), design verification, validation and quality management system documents.

4. Application Submission - The submitted dossier will be reviewed for its completeness. Either a “Notice of Acceptance” or “Deficiency Letter/ Notice of Rejection” will be issued based on the results of administrative review. Administrative timelines include initial document check, NMPA decision evaluation, as well as certificate issuance.

5. Technical Review - NMPA conducts primary and secondary technical reviews, followed by potential supplementary requests.

6. Approval & Certificate Issuance - If all requirements are met, market authorization will be granted.

Key Registration Timelines and Fees

The table below summarizes key details for foreign medical device manufacturers based on the risk classification of their products:

Class I Medical Devices

Class II Medical Devices

Class III Medical Devices

Additional Considerations

The above estimates do not account for additional factors that may impact the overall timelines and costs:

• Additional internal or external testing according to local standards, pre-submission or after receiving supplementary notice

• Additional time required by the applicant to evaluate, seek consultations, perform testing, and compile documents during the supplementary period

• Class II & III devices may require additional clinical data or clinical trials if the submitted clinical evaluation is not sufficient.

• Regulatory inspections of the applicant’s quality management system (QMS) may be conducted randomly.

How Long Can the Entire Process Take?

The overall registration timeline for medical devices in China varies significantly based on risk class, clinical trial requirements, and the complexity of the technology. While Class II and III devices undergo a more stringent process, their registration timelines can extend to 12–18 months and 2–3 years, respectively.

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Disclaimer: This content is created solely in my personal interest and do not reflect the views, opinions, or policies of my employer or any other organizations I am affiliated with. The information provided is for general informational purposes only and should not be construed as professional advice. Neither I nor my employer is liable for any use of this content. This newsletter is non-commercial and does not compete with my employer’s interests. Any references to regulatory updates or guidance are based on publicly available information and are not intended to infringe upon proprietary or confidential content.