Regulatory News from Across Asia-Pacific

On 14.02.2019, the MOFCOM suspended the filing and administrative approval of direct selling companies due to unreasonable promises with regards to health foods. In collaboration with the SAMR, MOFCOM is overhauling the health food market in China by optimizing the direct sales regulatory system.

On 28.03.2019, the MOA (Ministry of Agriculture), published a notice regarding two administrative licensing items, which were abolished on 27.02.2019. First, the clinical trial approval of new veterinary drugs was changed to filing system. After completion of the laboratory study of the veterinary drug, the clinical trial can be carried out, without waiting for the approval of the authority. Second, the MOFCOM (Ministry of Commerce) no longer issues import licenses for veterinary biological products. It is no longer necessary for the Chinese import agent to provide such a copy when applying for customs clearance.

On 28.03.2019, the SAMR (State Administration for Market Regulation) released three major adjustments to health food function claims, which are open to public comments. First, 18 health function claims are being modified because they are deemed imprecise, misleading or exaggerated. For instance, SAMR suggests to replace 减肥 (Fat reduction) with 有助于调节体脂 (Bodyfat Adjustment Support). Second, 21 existing health food function claims might be cancelled. Even though they were considered acceptable in the past, they will not gain approval when reviewed now. For example 促进头发生长 (Promotes hair growth). Third, 6 health care function claims will have to be further studied and proven, as they are easily confused with drug-like disease prevention or treatment. For example 辅助降血压 (Helps Lower Blood Pressure).

On 01.04.2019, the NMPA (National Medical Products Administration - former NMPA) announced a change in the clinical trial approval process for medical devices (NMPA No. 2019-26). If the applicant has not received any feedback within 60 working days from the date of clinical trial approval application, clinical trials can be carried out. Instead of an approval notification, the NMPA’s website will display the approval number, the applicant's name and address, as well as the name, the model specification, structure and composition of the medical device.

On 13.03.2019, the SAMR (State Administration for Market Regulation) released new review measures for advertisements for pharmaceuticals, medical devices, health foods, and food for special medical purpose. The draft is open to public comments.

On 18. February 2019, the Chinese market supervisory authority SAMR (State Administration for Market Regulation of the Peoples Republic of China) announced further measures and regulations in the area of special and pressure equipment. A simplification is being sought, similar to the one already initiated for the CCC (China Compulsory Certification) in 2018.This affects holders of the China Manufacturer License (CML) from the China Special Equipment Licensing Office (SELO). They include among other things pressure equipment (containers, pipes), boilers, valves, bursting discs, freight cranes, lifts, cable cars, special vehicles and amusement facilities.Based on the current official information, we can summarize the changes as follows:

1) Optimization measures for acquiring the administrative license for special devices

• Reducing the time required for approval (provided that the application has been submitted correctly and in the complete form) and simplifying the application documents.
• The manufacturer is to be given the option of self-declaration for the licence renewal.
• Simplification of the certificate renewal procedure for special equipment licensees.
• Official fees for the application will be subsidized by the Chinese government.
• Further digitization of the application procedure.

2) Intensification of surveillance measures

• More frequent inspection of manufacturers after receiving the licence due to quality defects found during factory inspections or reported to the authority. This also includes unannounced inspections.
• Stricter review and inspection of relevant safety specifications during type testing and factory inspection.
• For manufacturers who obtained a licence by self-declaration, the licence will be withdrawn by the authority if untrue content is found in the application documents.
• Publication on the Internet of information on the licence holder about accidents caused by quality problems and the discovery of false information. For Chinese companies, this will also have an impact on their point in the PRC's Social Credit System.

The self-declaration for the license extension will come into force on 01. June 2019.Other regulations are to be implemented from 01. March 2019.Many details on the concrete implementation have not yet been published by the authority SAMR and impair the ability of the responsible authority SELO to operate.It is also not yet known whether all of the above-mentioned points will also apply to foreign licensees or applicants from the time of their entry into force.

Related news from us:

https://cisema.com/en/news-en/ccc-en-2/china-ccc-certification-obligation-lifted-for-numerous-products/

In the article A fortunate opportunity? Navigating Chinese regulation challenges to ensure success Anna Fischer from Cisema Hong Kong sets out the key challenges that foreign manufacturers of medical devices face in obtaining approval for and access to the Chinese market. Read the article on MedTech ENGINE.

On 14.08.2018, the SAMR defined the 8th batch of Drug - Medical Device Combination Products in their announcement No. 218-2018. When applicants are unsure, whether a product is categorized as a medical device or drug, a classification application can be submitted to the SAMR for verification.

Following the large scale institutional reform in March 2018, declarations for inspection and customs were integrated by China Customs in order to improve efficiency. Since 01.08.2018, enterprises are only required to file one Customs-and-Quarantine Declaration form.

On 01.08.2018, the SDA published the interpretation for the new Medical Device catalogue, which contains some changes regarding classifications. Some Class II products have been upgraded to Class III and some Class III products shall be considered as Class II.

As mentioned in our March/April news: On 13.03.2018, during the 13th National People's Congress, China’s cabinet decided for the SAMR (State Administration for Market Regulation) to supervise the - NMPA (China Food and Drug Administration), - AQSIQ (General Administration of Quality Supervision, Inspection and Quarantine), and- SAIC (State Administration for Industry and Commerce).The “3 stipulation scheme” published in August by the State Council details the staffing, administrative structure and functions of the SAMR.

On 27.09.2018, the NMPA published two Medical Device Regulation Indices (1998-2013) (NMPA WeChat announcement Nr.37. 2018). The first Index includes 114 still valid regulatory documents, covering classifications of specific devices, regulations for non-medical devices, technical guidelines, industry standards, GMPs and post-market penalties. The second Index includes 119 regulatory documents, which are no longer valid.

On 08.10.2018, the CMDE released new guidelines for the technical review of the sterilization processes of sterile medical devices for public comments. It includes requirements for the preparation of relevant documents as part of the registration of sterile medical devices.

On 30.09.2018, the NMPA published a revised “Clinical Trial Exemption List for Medical Devices and IVDs”, which was immediately implemented (NMPA No. 94-2018). 63 Class II and 21 Class III medical devices, 246 Class II and 31 Class III IVDs were added. The new clinic trial exemption list now contains a total of 855 medical devices and 393 IVDs.