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 in 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 in 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 in December 28, 2018, Content of Site Master File shall include documents on 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 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 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 make modification or not, which is a part of our post-market surveillance service.  
In addition, certificate modification should be done not only for manufacturer residence, but also for 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 compliant to 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 with 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 report and recall related report are through the same portal?

The adverse event shall be reported to 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 allow 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 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 case, 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 compliant to China 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 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 English version, and we can provide you by charging $200/each copy. 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 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.