Frequently Asked QMS PMS Questions (FAQ) about Quality Management Systems (QMS), Post Market Surveillance (PMS), and Overseas Inspection:
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
If medical device registrants and recorders entrust production, they should evaluate the quality assurance and risk management capabilities of the entrusted party, sign a quality agreement and entrustment agreement with them in accordance with the requirements of the entrusted production quality agreement guidelines formulated by the State Food and Drug Administration, and supervise the entrusted party. The party shall perform its obligations under the relevant agreement; the entrusted production enterprise shall organize production in accordance with laws, regulations, rules, medical device production quality management specifications, mandatory standards, product technical requirements, entrusted production quality agreements, etc., be responsible for production actions, and accept Supervision of medical device registrants and filing persons. The entrusted production enterprise shall report the increased product varieties to the original production licensing or production registration department, and provide information on the entrusting party, entrusted production products, entrusted period and other information; if the increased production of products involves changes in production conditions that may affect product safety and effectiveness, it shall Report to the original production licensing department 30 working days before adding additional products, and the original production licensing department should conduct on-site inspections in a timely manner. If there is a change in licensing matters, the relevant licensing changes shall be handled in accordance with regulations. Medical device registrants and filers should be responsible for product release on the market, establish product release procedures, clarify release standards and conditions, and review medical device production process records and quality inspection results. If the standards and conditions are met, authorized release personnel Can only be listed after signing. If production is entrusted, the medical device registrant and filing party shall also review the production release documents of the entrusted production enterprise. The entrusted production enterprise shall establish production release procedures, clarify the standards and conditions for production release, and only products that meet the standards and conditions can be shipped from the factory. Products that do not comply with laws, regulations, rules, compulsory standards and registered or filed product technical requirements shall not be released from the factory and put on the market. Medical device registrants and filers are not allowed to entrust entrusted production enterprises to release the products for sale.
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.
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.
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.
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.
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.
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.
After a medical institution submits an adverse event report to the National Medical Device Adverse Event Monitoring Information System, the municipal monitoring agency should complete the review of the authenticity, completeness, and accuracy of the report within 10 days. Before the adverse event report is reviewed by the municipal monitoring agency, Medical institutions can apply to return it for modification or deletion. Reports reviewed by municipal monitoring agencies cannot be returned or deleted.
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.
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.
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.
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.
Striving to meet good manufacturing practices (GMP) for medical devices in China can be challenging. The following article will provide answers to the most common questions about GMP for medical devices in China.
While it is true that good manufacturing practices (GMP) for medical devices in China can be challenging to achieve, they are necessary to ensure that your product is safe and effective for use. Having good manufacturing practices (GMP) in place will provide peace of mind to you as a manufacturer, knowing that you are producing consistent, quality products and therefore are reducing risk to your company and the user while simultaneously protecting the company reputation.
In order to expand its medical device market, China is driving GMP standards to be more closely aligned to International Organization for Standardization (ISO) standards. Guidelines are applicable to onsite inspections for sterile, implantable and IVD devices.
Good manufacturing practices (GMP) for medical devices tend to be centered around the following areas;
Ensuring that a manufacturer pays special attention to the following will result in acceptable, GMP standards;
Upon registration, a manufacturer must apply for their license in which case, a GMP audit will be performed.
Thereafter, in an attempt to enforce GMP, surprise inspections will be implemented. A manufacturer may be fined for being out of compliance with good manufacturing practices. You may consider hiring an experienced Chinese Quality Assurance Inspector to ensure that your process meets GMP standards.
On December 28th, 2018, National Medical Products Administration (NMPA) issued ‘Administrative Regulations of Drug and Medical Device Overseas Inspection’ (NMPA order No. 101 2018) implemented from the date of publication. Overseas inspection is the global common way for medical device inspection and one of the important steps for Chinese medical device inspection to be internationalized. The Regulations have essential effects for supervising overseas enterprises to comply with Chinese regulations.
NMPA is responsible for medical device overseas inspection. NMPA makes inspection tasks through risk evaluation and random selection in accordance with the suggestions of draft inspecting medical devices, R&D site and manufacturing site from relevant departments. Center for Food and Drug Inspection of NMPA (CFDI) is responsible for specific organization and implementation of medical device overseas inspection. Relevant departments will assist with the overseas inspection.
Overseas MAH shall submit CFDI ‘Letter of Authorization’ and ‘Basic Information Table of Overseas Inspecting Products’ in 20 workdays and submit main documents of inspecting site and other necessary materials in 40 workdays after receiving ‘Announcement of Overseas Inspection’.
There are several new regulations that overseas enterprises need to consider:
ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a certified NMPA (CFDA) legal agent with offices in Boston and Beijing, we represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.