1. What is medical device ?

Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of

-- diagnosis, prevention, monitoring, treatment or alleviation of disease,

-- diagnosis, monitoring, treatment, alleviation of or compensation for an injury,

-- investigation, replacement, modification, or support of the anatomy or of a physiological process,

-- supporting or sustaining life,

-- control of conception,

-- disinfection of medical devices,

-- providing information for medical purposes by means of in vitro examination of specimens derived from the human body,

Key Point:

The intended purpose and action principle is the key to distinguish medical device, drug, health food, health products and cosmetics

2. How to define the Class of medical device? Why is the classification of medical device important in the registration process?

Medical device is divided to be three classes:

Class I are those medical devices the safety and effectiveness can be ensured via routine administration;  

Class II are those medical devices the operational principle and technique is accepted by the international and domestic, the safety and effectiveness of control is required.

Class III are those medical devices which are implanted into the human body, or used for life support or complicated structure and technique, or potential risk existed to the human body, the safety and effectiveness should be strictly controlled. More details, please see the Classified Catalogue.

The files prepared for registration may different depending on classification. Concrete request can be found on medical device registration management regulation.

Key point:

The same product may be classified in different class in different country due to the different regulation should be complied.

If the product is not specified in classified catalogue published by SFDA, you shall submit classification application to SFDA Standard  Service Center before registration. Only after the product defined classification by Standard Service, it can be registered according to relevant procedure and requirements.

3.What is the medical device product standard ? How to classify the standards ?
Product standard is product registration test standard, which is the quality foundation of product registration. There are national standard (GB), industrial standard (YY) and medical device registration standard (YZB, the medical device registration standard made by enterprise themselves according to the actual state of product.)

4.What is the basic information required in import medical device registration ?
Please refer to the relevant service.

5.What is the basic information needed in domestic medical device registration ?
Please refer to the relevant service.

6.How long does an import medical device get the registration certificate from beginning？
The time can divide into three stages:

1.    Documents Preparation

The duration time depends on whether the document prepared by principal is qualified or not.

2.    Product Type Test

45 working days is set by the SFDA, BUT the duration may be delayed regarding the electrical medical device for 60 working days and the different biocompatibility tests for different test turnover time.

3.    Document Review and Registration Certificate Approval.

105 working days is set by the SFDA if no problem comes up during the process. Once the any supplement of the application files happened, the process will pause unless the qualified files is accepted.

Generally speaking, it may take 9-10 months for one Class II or III registration certificate from beginning to get the registration certificate finally ( Not including clinical test time and special biocompatibility test time)

7. Which government approvals should get during the medical device registration process?

The departments involved in the registration process are: Municipal FDA for class I medical device, Province FDA for class II and III、Domestic medical device products involving government departments include: municipal people's government food and drug administration (ClassⅠ).The provinces, autonomous regions and municipalities directly under the central government food and drug administration (Class Ⅱ，Ⅲ), state food and drug administration medical device department sevice office ,medical device registration technical audit center, medical device department registration bureau ,national designated testing center.

The imported medical device product registration involving departments include: state food and drug administration medical device department sevice office ,medical device registration technical audit center, medical device department registration bureau ,national designated testing center.

8. Which kind of products need for clinical test?
Domestic Class II/ III medical device

Import Class II/ III medical device which has not got the listing document in country of origin

Class III long-term implanted products, if producer has never obtained product registration certificate inChina

Specific requirements can be found in measures for clinical trials in medical device registration administration regulation.

9. Where should the products be detected ?

The SFDA designated testing center mainly includes 10, they are respectively:

Beijing medical equipment quality supervision inspection center

Peking  University medical equipment quality supervision inspection center

In the check medical equipment quality supervision inspection center

Shanghai medical equipment inspection bureau

Tianjin medical equipment quality supervision inspection center

Guangzhou medical equipment quality supervision inspection center

Jinan medical equipment quality supervision inspection center

Wuhan medical equipment quality supervision inspection center

Liaoning medical equipment quality supervision inspection bureau

In addition, there are other test centers in the SFDA web site which are also released, but the products these test centers can check are less.

According to the examination scope of different test center to choose the test center for product testing.

10.What is the general requirements of application material ?
1. Application material should be bound into volumes according to the specified order.

2. Each file homepage of application material should be labeled hint labels on the right and mark the sequence number.

3. The documents written by enterprise should be printed according to A4 specification paper and the documents provided by government and other institutions provided according to the original size.

4. The copies of application material should be clear and the same as the original documents.

5. The materials in foreign languages should be accepted in application material according to regulations (except name and address) should be translated into standard Chinese, and attached  the translation after corresponding foreign material. Translation should be affixed company seal by producer or registration company entrusted by producers (Seal on the perforation is ok).

6. The same item in application material should be filled in same way and can not be inconsistent.

7. The product name in application material should use product common name. If it has trade name, it should be marked trade name. The product name and trade name are managed by registration certificate.
11.What is the requirement of the medical device containing drug ?

During the registration of the medical device containing drug product, the registration should  provide domestic registration certificate of drug part and related drug registration material (such as  pharmacokinetic reports, etc), in the condition of confirming documents above, it can be applied for the medical device registration approval according to relevant categories of medical devices.

Specific demanded can be found on the notification of about drugs and medical devices combining product registration management related problem.
12. How much is the fee of medical device registration ?
The applying company during the process of medical device registration application need to burden product testing costs (Import Class I product need not test). If the product need domestic clinical trials, the company will also need to burden clinical trials expenses. Another fee is the translation fee to translate application material into Chinese.
13. How to apply the material of none classified product ?

If some products can not be found explicit classification in Product Classified Catalogue announced by SFDA, they requires to submit classification application and confirmed the product classification by SFDA standard bureau before starting the registration work, and then provide corresponding application material according to the product classification. The classification application material submitting to SFDA need to describe the product in detail.

Import Class I medical device registration required documents

Import Class II and III medical device registration required documents

No registration in abroad Class I medical device registration required documents

No registration in abroad Class II and III medical device registration required documents

Domestic Class I medical device registration required documents

Domestic Class II and III medical device registration required documents

14.Why choose Jiushun Enterprise Management?

Jiushun Management has determined the medical device consulting with adequate and systematic service as its major service since found on August, 1996. Jiushun has developed to be the one of the most qualified, widest service-providing and most customers in the Greater China (including Hong Kong, Macao andTaiwan).

We have provided the specialized service for more than 5,000 customers from the Greater China, UK, U.S.A, Japan, Singapore, Malaysia, etc. spreading all over the world, including 15 listed companies.

15. Which medical device item services does Jiushun Enterprise Management provide?

The medical device item services that Jiushun Enterprise Management provide:

　　◇Medical Device Certificate Consultation

　　CE、ISO13485、ISO9001、FDA、CMDCAS、PAL、YY/T0287、ISO11137/EN552、 ISO14001、 OHSAS18001

　　◇Version-Changing Consultation for Medical Device Certificate

　　◇Chinese SFDA Registration Consultation

　　Imported Medical Device Registration、Production License for Medical Device、Registration for Chinese Medical Device、Sales License for Medical Device、GMP Consultation for Medical Devcie

　　◇European Authorised Representative Service

　　◇Registration of MHRA

　　◇Certificates of Free Sale/FSC (domestic or overseas)

　　◇Transaction of foreign CE Certificate Notarization

　　◇Transaction of foreign FSC Certificate Notarization

　　◇Certificate Training for Medical Device

　　◇Appearance Design for Medical Device

　　◇Clinical Application Consultation for Medical Device

　　◇Translation for Medical File