Q&A – Medical Device/IVD/CDx QMS/PMS

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Do all the documents for NMPA Overseas Inspection need to be in Chinese?

Yes. According to “Administrative Regulations of Drug and Medical Device Overseas Inspection” issued on December 28, 2018, “the working language shall be in Chinese; documents such as application material and Corrective Outcome shall be in Chinese; English-Chinese translator shall be in place during the inspection.”

What documents should be submitted after receiving Notice of Overseas Inspection?

According to “Administrative Regulations of Drug and Medical Device Overseas Inspection” issued on December 28, 2018, “Manufacturers need to, within 20 business days after receiving the notice, submit the Medical Device Overseas Inspection Basic Information Form and authorization letter to the inspection center; and, within 40 business days after receiving the notice, submit site master file and other required information according to Content of Site Master File.”

For Overseas Inspection, which documents should be included in the Content of Site Master File?

According to “Administrative Regulations of Drug and Medical Device Overseas Inspection” issued on December 28, 2018, Content of Site Master File shall include documents on the following:

1. Manufacturer Overall Information
2. Quality Management System
3. Supplier(s) and Contractor(s) Management
4. Personnel
5. Manufacturing Facility
6. Equipment
7. Document Control
8. Manufacturing Process
9. Material and Storage
10. Quality Control
11. Sales, Distribution, Defect and Recall
12. Internal Audit
13. R&D
14. Documents Authenticity Statement

What the interval is for on-site surveillance audits after approval?

There is no certain timeline for the audits. The high-risk, implantable, or sterile devices do get higher chances to be picked for audits. We did the training for NMPA (CFDA) inspectors with U.S GMP personnel and know them well.

Is China considering being included in the MDSAP program?

Not yet. NMPA is not following MDSAP. But as China is more harmonized with international standards, it may consider joining MDSAP in the future.

For IVD, could you provide some more insight on post-market changes? Particularly for a new supplier or site moves. Do these changes trigger re-evaluation?

For IVD, if suppliers of major materials such as antigens and antibodies, certificate modification should be done by submitting the research data of the main materials after the change, the performance evaluation data, the clinical data, the product technical requirements, and IFU before and after the change and etc.

For the change of other suppliers, ChinaMed Device will make an assessment to identify if you need to make modifications or not, which is a part of our post-market surveillance service.

In addition, certificate modification should be done not only for manufacturer residences but also for the facility site movement. For facility site movement, some documents should be submitted including the upgraded quality management system, the new performance evaluation data at the new site, and the upgraded IFU and label template, etc. China Med Device will help our clients comply with China regulations during your post-market activities.

The adverse event “re-evaluation” is mostly triggered by serious events. If re-evaluation happens, you may need to do a subset of clinical study or clinical evaluation to prove that your device is safe and effective. Meanwhile, risk management analysis should be re-evaluated.

Is the type testing guidance doc on the site in English?

There is no specific guideline for type testing which is a process you go through. But the Product Technical Requirement (PTR) used for type testing must comply with relevant guideline(s) and standard(s).

Type testing is always done as per PTR. ChinaMed Device has a strong technical background to help you handle PTR writing as per China standards applicable to your product. PTR is an important registration document, which will be attached to your certificate as a priority item reviewed by NMPA.

Moreover, local type testing is required to be done in China at present, which could take a long time and be frustrating. We have onsite test engineers at the NMPA testing centers to support and facilitate the tests between the NMPA testing center engineers and the reviewers.

Adverse event reports and recall-related reports are through the same portal?

The adverse event shall be reported to the National Adverse Event Monitoring System.

There is no submission portal for recall. When a manufacturer makes a decision for recall, it shall immediately submit a Medical Device Recall Form, via paper documents, to the national NMPA and the provincial NMPA where the manufacture locates.

MAH policy allows the domestic company in china to get the product license first before the contracted manufacturer is authorized to produce the product. IS this true per MAH policy?

First, the contracted manufacturer you want to authorize will produce the test samples and clinical samples for the domestic company of your side in China, then your domestic company in China will use these samples for test and clinical trial to get the registration certificate, and subsequently, your side will authorize the contracted manufacturer to produce products.

Do packing slips need to be written in Chinese?

In normal cases, a packing slip is used for shipment, NOT a part of labeling, so it is fine not to be written in Chinese. However, the Instructions for Use and label must be in Chinese, according to the Regulation on Instructions for Use and Labels of Medical Devices published in July 2014.

China Med Device, LLC can review the IFU and label to help the clients comply with China’s requirement. Also, we can provide you the file format so that you can print locally, or we can print for you in China.

Is there a guidance document for NMPA inspection?

For domestic manufacturing inspection, the guidelines include:
1. Decree 64 Good Manufacturing Practice for Medical Devices
2. Decree 19 Good Manufacturing Practice in Class III Medical Device Manufacturers
3. Decree 101 Good Manufacturing Practices on Sterile Medical Devices
4. Decree 102 Good Manufacturing Practice for Implantable Medical Devices
5. Decree 103 Good Manufacturing Practices on In Vitro Diagnostic Reagents
6. Decree 218 Annex 1 Good Manufacturing Practice Guidelines for Onsite Inspection
7. Decree 218 Annex 2 Good Manufacturing Practice Guidelines for Onsite Inspection of Sterile Medical Devices
8. Decree 218 Annex 3 Good Manufacturing Practice Guidelines for Onsite Inspection of Implantable Medical Devices

For overseas inspection, the guideline is the Regulations for the Administration of Overseas Inspection of Pharmaceutical & Medical Devices.
Post-market compliance, AE, and annual reporting are getting more strict with the new regulations introduced since 2018 and the new NMPA (CFDA) system implemented in January 2019. Sterilized devices and implant devices are the focus of NMPA overseas inspection. We have a qualified bilingual and bicultural team with strong QMS and PMS background to help you perform pre, during, and post inspections.  Please feel free to let me know how we can assist you in your regulatory affairs and post-market compliance in China.
In addition, we have all the documents listed above in the English version, and we can provide you by charging a fee. Please let me know if you are interested in.

Are adverse events required to be filed each year for events that occurred in China only or should it be submitted for any global events?

NMPA issued Decree No.1 for Medical Device Adverse Event Reporting on August 31st, 2018. The Decree specifies that global adverse events are required to be reported. The document also states that the report of global AE must be submitted by a legal representative in China. Please see our post HERE.
We are an NMPA (CFDA) legal representative with offices in Boston and Beijing. We can represent manufacturers for the complete product life cycle without their need to create a local entity in China.

Are the current regulations around adverse events require reporting annually only?

For initial registrants, the Annual Adverse Events Evaluation Report must be submitted to NMPA once a year. For renewals, the risk assessment report must be submitted during the next renewal.

If a US medical device manufacturer obtains CE Mark under new EU MDR does that certification meet all or most of NMPA post market surveillance and adverse event reporting requirements in China?

Not covering China NMPA PMS requirement.

What is the database in NMPA for adverse event reporting? anything like FDA’s Maude?

Confidential for the manufacturer. YES, but not public.

Do you need to report SAEs occurring in China only or worldwide?

Worldwide.

[Orthopaedic Class III devices]: Does a revision surgery need to be reported to NMPA?

Depending on the reason for revision. If it is SAE, it should report to NMPA.

It is not easy to follow that user/hospital register AE. Which role do manufacturers and Chinese agents have on AE and PRER?

MAH determines, and Chinese agent follows. China Med Device is a full-service legal agent. We can assist you in collecting AE reports and work with you to define and submit SAE to NMPA.

Is there a template for PRER to be downloaded by legal manufacturers?

China Med Device is a full-service legal agent. There are details and on-going tracking. We can help you write the PRER and submit them for you.

Risk evaluation might be a wrong translation from NMPA. There is no risk and indeed just summary of AE, right?

No. If you say no, this is NOT a good answer. You should add an explanation of why no. Please explain.

Is the PRER (now called PSUR) similar to the EU PMS report?

Similar, but China has its own specific requirements.

Can we use the same literature report (for EU) for the corresponding section in china PRER?

No. If you say no, this is NOT a good answer. You should add an explanation of why no. Please explain. It could be simple.

Please confirm that warranty on capital medical device equipment has no bearing on whether a service issue may be deemed a regulatory complaint.

Not all service issues are regulatory complaints.

The PRER appears to be similar to a PSUR with regard to the required elements. Please confirm.

Similar, but China has its own specific requirements.

Does a revision surgery due to non-product related issues need to be reported to NMPA?

Depending on the reason for revision. If it is SAE, it should be reported to NMPA.

Is the PRER required to be submitted during annual Registration Renewal?

Not annual. The guidance documents specified the submission period requirements.

It would be nice to show an example of the content of the PRER?

Please contact us if your company needs customized training or service. We can certainly help.

When do you say ISO 14971 does NMPA require the latest version of standard i.e. ISO 14971:2019 or earlier version accepted for PRER?

The earlier version is accepted.

Is QMS requirement for China similar to ISO 13485 or are there any major changes manufacturer should be aware of?

Similar, but have major differences. China Med Device can provide customized training services to help overseas companies understand the big differences.

If your device was approved in 2020, is the first PRER due in 2021?

Yes.

In the PRER, are the product change notifications/applications required to be listed for all main countries?

Yes.

Can you please restate what events need to be reported in the PRER? Only those events that actually cause D/SI and those that MAY cause D/SI if they were to reoccur? Or those that are LIKELY to lead to D/SI if reoccur?

AE likely to lead to D/SI need to be reported in PRER.

IS ISO 14971:2019 is mandated for the PRER by NMPA?

No.

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