Kategorie-Archiv: News

New CFDA-Catalogue for Medical Devices

CFDA published a new catalog for the classification of medical devices.

The CFDA (China Food and Drug Administration) published a new classification catalog on 31.08.2017 (No. 2017-104). The new catalog, with more than 2,000 entries of product classifications, is much more extensive than the previous catalog, which featured only around 200 product examples. It is clear that many product classifications will change as of 1 August 2018, when the new catalog and its implementation regulations are put into effect. Excluded from this are in-vitro diagnostics reagents, as their currently used classification guidelines will remain valid.

  Old Classification Catalogue New Classification Catalogue
Entries of product examples

~200

>2,000

Categories

43

22

Class I subcategories

104

380

Class II subcategories

123

777

Class III subcategories

7

404

CFDA revised two regulations regarding food for special medical purposes

On 6 September 2017, CFDA published announcement (No. 2017-108), in which the “Application Documents and Requirements for the Registration of Food for Special Medical Purpose (Trial)” and the “Stability Research Requirements on Food for Special Medical Purpose (Trial)” are revised.

Certification requirement for all food imports to China is suspended until 30 September 2019

As mentioned in our Foreign Trade News from July 2017, food products should only be imported in China with an official certificate of clearance as of 01.10.2017. The WTO (Word Trade Organization) is now circulating a communication (dated 22 September 2017) on behalf of AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine) announcing that, on the basis of the comments received, a transitional period of 2 years will be granted.

For further information on the above topics, please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00
info@cisema.de
www.cisema.com

China RoHS 2.0 „Compliance Management Catalog“

China RoHS 2.0 „Compliance Management Catalog“ progressing to next phase.

On February 3rd 2016 the responsible authorities (published an update on the regulation for hazardous substances – RoHS 2.0. The regulation is effective since July 1st 2016 (we reported).

Originally a „Compliance Management Catalog“ was scheduled for publishing in October 2016. The content should provide a definition, whether a mandatory registration, and possibly an inspection of the manufacturer, will be introduced. So far there was no progress. On July 28th 2017 a consultation of the authority MIIT with business representatives ended. We expect to receive further information about the future approaches for China RoHS by end of this year.

For further information please contact:

Cisema China Certification GmbH
Tel.: +49 89 4161 7389 00
Fax: +49 89 7484 9956
info@cisema.de
www.cisema.de

 

Certificate of Clearance for all Food Imports

AQSIQ is planning to introduce an official certificate of clearance for all food imports.

On 1.10.2017 announcement 83 2017 issued by AQSIQ (Administration for Quality, Safety, Inspection and Quarantine of China) will come into force. From then on, all food exported to China must be accompanied by an official certificate of clearance, which is to be issued by the competent authorities in the country of origin. Up to now, AQSIQ has not communicated any details, like which authorities are accepted by AQSIQ or which information is to be contained in the certificate.

Many of China’s trade partners have already filed a note of protest at WTO against this regulation and the feasibility of the Chinese plans is most uncertain according to expert opinions.

We shall inform you immediately, if there are any news on the certificate of clearance.

For further information please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 00
Fax: +49 89 7484 9956
info@cisema.de
www.cisema.com

CFDA Formulates Confidentiality Measures

CFDA has Formulated Confidentiality Measures in Regards to Review and Approval of Drugs and Medical Devices.

In order to protect the rights and interests of the manufacturer of pharmaceuticals and medical devices, CFDA (China Food and Drug Administration) issued a code of confidentiality for all employees involved in the registration process.

According to the code, all employees involved in a registration process must sign a confidentiality agreement, whose compliance is strictly monitored. Should an employee be in violation of the agreement, he will be punished. Depending on the severity of the failure, the consequence is a disciplinary punishment which can range from a written warning or dismissal up to legal action against the employee.

If the applicant of the registration can prove that the information disclosed by relevant staff or expert leads to losses, he has the right to file a lawsuit.

If the CFDA pays a compensation according to the judgment of people’s court, they will reclaim part or all of the compensation costs from the violating employee or expert.

For further information please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 00
Fax: +49 89 7484 9956
info@cisema.de
www.cisema.com

Simplifications of Clinical Studies

Simplifications of clinical studies for medical devices and pharmaceutical products in China.

On 11.05.2017 CFDA (China Food and Drug Administration) issued two announcements – no. 2017-52 and -53 – handling the simplification of clinical studies in China. Medical devices and pharmaceutical products can thus be launched in China much easier.

1. Policies about promoting market approval of new and innovative drugs and medical devices:

This proposal refers particularly to innovative treatment methods for life-threatening diseases. If such a product turns out to be successful at an early stage of the clinical study, it can be put on the market with reservations even before the clinical study has been finished.

2. Policies about administration of clinical trials on the innovation of medical devices and drugs:

This is an initiative which allows all hospitals and medical institutions to carry out clinical studies in China, which, up to now, only specially accredited hospitals of the highest category, were allowed to do. In the future, a medical institute only has to register on the CFDA website, in order to be allowed to perform clinical studies.

Furthermore, the draft allows clinical studies which were performed abroad to be used for product registration in China, as long as they comply with the “Requirements of the CFDA Drugs and Medical Device Registration”. The only exception are eight Class III high risk medical devices like implantable cardiac pacemakers, blood pump, infusion pump for medicines, stents, artificial organs and orthopedic components (see CFDA Notice 2014/14 ).

On 17.05.2017 the draft of the third revised list for medical devices exempted from clinical studies was issued. It contains 22 class II and 6 class III products.

These measures will give Chinese patients a faster access to innovative and improved treatments and reduce the launching costs.

CFDA has used much effort in the past years to make the registration process more efficient and safe. The number of employees working for registration was increased by 450 in a period between mid-2015 and end of 2016, which means a fourfold increase.

In April this year the Supreme People’s Court of the People’s Republic of China announced a new interpretation of the criminal code, according to which persons who forge clinical studies are facing severe punishment. If a drug, which was registered with forged clinical studies and caused injury to a patient’s health, the forger faces a 10 years’ imprisonment – if the patient dies, even a death sentence is possible. Even if the drug in question was not registered and did not cause any harm, the submission of falsified registration documents is punished with a 3 years prison sentence. Should any organizations entrusted with the performance of clinical studies be involved in any fraud, their accreditation will be cancelled.

For further information on the above topics, please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00
info@cisema.de
www.cisema.com

Registration of Infant Formula in China

Registration of Infant Formula in China is booming.

As already reported in December last year, the CFDA issued the rules for registration of infant formula on 8.6.2016, and on 22.11.2016 the new online-platform for the registration of infant formula was launched. Until01.01.2018 Chinese as well as foreign manufacturers of infant formula must get their registration certificate, otherwise their products cannot be imported or traded in China. Ever since CCAP has had an enormous increase in applications for registration of infant formula, up to now more than 60 manufacturers have applied for registration of 213 products.

CFDA announcement No. 2017-65 of 25.5.2017 (Application Documents and their Requirements for Infant Formula Registration) simplified the application for registration, in order to make sure that the first applicants get their certificates before the deadline on 01.01.2018.

If you have further questions in regard to above mentioned topic, please do not hesitate to contact us:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00
Fax: +49 89 7484 9956
info@cisema.de
www.cisema.de

MEDICA – CFDA Registration seminar

During this year’s MEDICA in the TECH FORUM Stefan Fischer CEO of Cisema GmbH will hold a seminar in English on 14.11. from 13:00 to 14:00 h on CFDA registration of medical devices in China.

The seminar will be a cooperation between Düsseldorf Trade Fair, SPECTARIS (trade association for medical devices) and ZVEI (association for electromedical technics).

We shall be pleased to see you – you can also make an appointment with Mr. Fischer, who will be at the Fair on 13. and 14. November 2017.

Tel: +852 9539 5030 | Fax: +852 3596 9776 | E-Mail: fischer@cisema.com |

MedicaSpectarisZvei

CFDA Annual Report

China Food and Drug Administration (CFDA) report on registration of medical devices in China.

CFDA recently published its Annual Report 2016 on medical device registration. The number of registrations in Class II, III and IVD has increased to 8.653, which is a plus of 14.9 % compared to the previous year. The retracement suffered in 2015 was due to the various regulatory changes dating back to 2014 as well as the increase of application fees in 2015, but the current figures have reached the 2014 level again.

A large percentage of applications for the registration of medical devices and IVD comes from abroad. Class II had 3.095 applications from abroad, which is an increase of 2% compared to 2015 and in Class III there were 2.818 applications, an increase of even 15%.

The P.R. China continues to promote the import of high-end and high-cost medical devices from abroad. The top five class II and III product groups of foreign origin to be registered in 2016 were:

  1. Implanted material and artificial organs (509) – was on place 2 in 2015
  2. Medical optical instruments, devices, and endoscopes (406)
  3. Medical electronic instruments and devices (285)
  4. Medical polymer material and products (249)
  5. Devices and instruments for OR, IR, and Doctor’s consulting room (141) – superseded dental care equipment.

According to the CFDA report 2016, top of the list of registrations of foreign class II and III products (including IVD) were the USA followed by Germany, places 3, 4 and 5 were held by Japan, United Kingdom and Korea.

Further information concerning this topic can be obtained from:

Cisema GmbH
Tel.: +49 89 4161 7389–00
Fax: +49 89 7484 9956
info@cisema.de
www.cisema.com

Prolonged Deadlines for the Renewal of CFDA Registration for Cosmetics

Renewal of CFDA (China Food and Drug Administration) Registration for Cosmetics.

On 1.9.2017 the CFDA (China Food and Drug Administration) Announcement #1378 will come into force, according to which the processing time for application for renewal of the registration will be increased.

Application for cosmetic license renewal has to be submitted six months ahead of expiry date, before it was four months

  1. If any other change is to be filed, the application has to be submitted ten months before expiry. An application for license renewal can be handed in simultaneously.
  2. CFDA technical review for license renewal shall be finished within 3 months counting from the acceptance date.

Further information on this topic can be obtained from:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00
Fax: +49 89 7484 9956
info@cisema.de
www.cisema.com

CBEC (Cross Border E-Commerce) – Deliveries Classified as Products for Personal Use

Online Trade – Deliveries Classified as Products for Personal Use.

As of 1st January 2018 the Chinese customs authorities will treat all commodities traded through CBEC as articles for personal use. The reason is that commodities traded through CBEC are for private persons and usually have a low value and low quantities.

Another five pilot cities for CBEC will be nominated: Besides Hangzhou, Tianjin, Shanghai, Chongqing, Zhengzhou, Guangzhou, Ningbo, Shenzhen, Fuzhou und Pingtan, there will now be added Chengdu, Dalian, Qingdao, Suzhou und Hefei.

More details for the supervision will be published shortly. It can be assumed, however, that certain product groups which normally need registration or certification, can be traded and imported freely through CBEC. Among these commodities are:

Ordinary cosmetics such as lotion, cream, facial mask, shampoo

  • Nutritional supplements such as vitamin and mineral preparations
  • CCC products such as coffee machines, vacuum cleaner
  • Freely traded medical devices such as electronic sphygmomanometer

It has not been decided yet if the new regulation also applies to infant formula.

Further information on this topic can be obtained from:

Cisema GmbH
Tel.: +49 89 4161 7389 – 00
Fax: +49 89 7484 9956
info@cisema.de
www.cisema.com