Q&A

Q&A of medical device (IVD) in China

1. What is "country of origin" approval?

It is also called home country approval. One of the most important prerequisites of medical device registration in China is country of origin approval. This means, where the legal manufacturer is located, the product certificate issued by the authority there is a MUST for initial and change registration.

You dont need home country certificate to make a nenewal every 5 years in China. Extend your Chinese products life even it is not valid under MDR till 2027/2028.

In EU it refers to EC certificate and Declaration of Conformity and in US to certificate to foreign government.

Another option of country of origin is to get medical device approved at manufacturing site instead of legal manufacturing site outside China.

2. What is electronic regulated product system (eRPS)?

This system is a platform to submit the electronic technical documentation to authority in term of medical device registration in China. Only the Chinese entity (e.g. Chinese agent) needs this system. Neither Chinese distributor or foreign manufacturer can apply the account without role of Chinese agent.

It is similar to eSTAR in US and Canada.

It applies to all registration types of class II and III medical device, except to class I medical device.

As of 1. Nov. 2019 all registration documents have to be submitted through eRPS system, and so forth in new submission format of technical documentation in line with the “ table of contents” of IMDRF.

3. How to change Chinese agent ?

You can change Chinese agent any time in China unless the original product certificate is not available (NMPA certificate and product technical requirement).

We reccommend you to keep electronic Chinese certification and all Chinese submitted dossier on your own hand.

"Change of Chinese agent" belongs to change registration in administration matter. The review time by authority is 10 working days and there is no official cost.

As Chinese agent you have many post market obligations:

Register of UDI, Report of adverse event and recall, Submit annual QM report, register assurance code and report of PSUR.

4. What can I do if I miss “Chinese medical device certificate”?

NMPA certificate and product technical requirement are extreme important. Like without having passport you can`t enter China. If you even dont have electronic Chinese product certificate, legal manufacturers can apply to reissue a new certificate in lost cause.

In accordance to order 91 , 2015 the new certificate will be reissued in 10 working days and there is no official cost. The “lost” certificate will be invalid.

5. When is a pre-submission meeting appropriate?

There is also a pre-meeting system in China, in prior to product registration to organize a meeting with CMDE. However, there is only once monthly on Friday to have this chance to get opinions from experts at Chinese authority. Manufacturers can mandate any agents to apply one slot on Friday either online or by going there personally without pre-registration.

For one pre-meeting manufacturers can pose 5 questions. Normally you can get a very brief answer in written form after pre-submission meeting.

Unlike Q-submission in US, you can`t have a professional pre-submission assessment of your tactic and technical documentation.

6. How is procedure of application of product classification?

In case, you are uncertain whether you product is medical device in China, or you can`t find matching product code with precise intended use to your product, you can submit an application of classification at national institute of food and drug control (NIFDC).

The typical document to submit is product description (intended use, about similar product...), product photo or video, risk management file, product technical requirement, ANY overseas approval, instruction for use (draft) and other technical supporting material. It is free of charge and take around 30 calenda days.

7. Does bundle of product group for registration exist at NMPA?

Yes, in term of one unit including all models and variants, manufacturer can make one product registration if the products in one unit have same intended use, technical characteristics, mechanism of action and materials.

It is recommended to clear the naming rule of the products up at submission dossier by explaining the meaning and difference of the models and variants.

8. What is overseas inspection and Chinese sampling inspection?

For overseas manufacturers it is sufficient to submit ISO 13485 certificate for product registration. After product approcal NMPA inspects the overseas manufacturers’ facilities rather in a risk-based and random basis than FDA or annual inspection by notified body.

First in 2018 there is guidance “Overseas inspection of Drug and Medical Device” to be compliant with by overseas manufacturers.

Overseas manufacturers can assign any agents to accompany the inspection by NMPA. After receiving the inspection notice the agents must give basic information of AE and power of attorney in 20d, as well as site master file and other supportive documents in 40d. The inspection of medical device includes general info about legal manufacturer, supplier management, personals, manufacturing site, equipments, document control, production and material storage .

If the manufacturers get the findings in inspection report, by objection a clarification must be made in 10d. At the end, manufacturers have to provide feedbacks (it could be plans of finding measures) in 50d to authority.

9. Post Market Surveillance

a. How to report adverse event in China?

As of 01.01.2019 the new requirement about reporting of adverse events in China is into force. Due to guidance “Adverse Events Monitoring and Reassessment of Medical Device” the reporting of AE is strongly strengthened. The Market Authorization Holder applies for legal manufacturer or Chinese agent of overseas manufacturers. User facility and distributor are also involved in monitoring of AE.

The registration - and report timeline of AE in China:

Adverse event of Medical device	Type	Registration time	Report time
Individual	Death	7d	30d
	Serious injury	20d, 30d for overseas AE	45d
Group	Group	12h, for each AE in 24h	7d

b. What is period risk evaluation report (PRER)?

This is a part of requirements under two regulations at question 9a above. NMPA published in 2020 the guidance “period risk evaluation report of medical device”. The name of guidance is confusing. It is actually better to be translated to “summary of adverse events with risk evaluation”. Risk evaluation can be interpreted as analysis of reasons and measurements of AE. It applies to AE of medical device worldwide including in China. The overseas manufacturers have to submit English and Chinese report.

For class II and III medical device, the PRER has to be submitted electronically each year after initial approval date till first extension registration.

For class I medical device and from first extention registration of class II and III medical device, PRER is just needed to keep internally as records, namely every 5 years.

Period risk evaluation report in China is a abbreviate Periodic Safety Update Report (PSUR).

Use our template to have a fast and professional record of Chinese PSUR.

10. What is approval of medical device in emergency need in Hainan Province?

In 2020 there is a wide spread notification from Chinese authority that some special medical device can undergo rapid approval in Hainan province . In fact it applies only to medical device in emergence need for rare disease and for prevention or treatment of severely life-threatening disease.

The MD must have its country of original approval and there are no similar products in China.

Secondly the overseas manufacturer has to find a user facility with “good clinical practice” and to fulfil other conditions as reporting adverse event capabilities.

Both parties can then apply for an evaluation of medical device in emergency need by authority in Hainan.