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On 08.11.2019, the SAMR announced the interim implementation of Administrative Measures for Product Quality Spot Inspections (No.18-2019) and Consumer Goods Recall Management (No.19-2019).The Administrative Measures for Product Quality Spot Inspections adopts the sampling inspection process on e-commerce platforms as listed, but not restricted to the following:- The inspector authorized by SAMR can initiate the sampling process by online purchasing the sample as a consumer- The inspector authorized by SAMR should document the e-commerce account, address, and contact information used for online purchasing the sample,and all information should be documented by screenshot, photo taking or video recording- The process from receiving to unpackaging the parcel of the sample product should be recorded by photo taking or video recordingConsumer Goods Recall Management replaces the Administrative Provisions on the Recall of Children's Toys with refinements made applicable for all consumer products. The original Administrative Provisions on the Recall of Children's Toys was released on 27.08.2007, and will be abolished once the Consumer Goods Recall Management comes effective.Administrative Measures for Product Quality Spot Inspections and the Consumer Goods Recall Management will commence on 01.01.2020.

On 22.11.2019, China's NMPA (National Medical Products Administration) announced a draft regulation concerning overseas inspection for cosmetic products, and launched the public consultation to receive feedback.According to the proposed regulation, it aims to introduce, standardize and optimize the inspection process. Once adopted, inspections on foreign manufacturers are required to be conducted by Chinese authorities from NMPA, which includes on-site inspections for any overseas facilities involved with the manufacturing process of cosmetic products that are intended to be sold in the China market.China NMPA will continue to solicit public opinions until 22.12.2019.

From October 25^th to November 1^st, China SAMR publicly solicited opinions upon its release of the third draft on the measures of advertising review management for health food, FSMP, drug products and medical devices.SAMR had been open to public feedback from March 13^th to April 13^th and June 6^th to June 26^th followed by adjustments made to the first and second draft.As revealed in the previous announcement and drafts, SAMR aims to formulate a major regulatory reference in future by requiring compliance for advertising health food, FSMP, drug products and medical devices including, but not limited to, the following conditions:Content (e.g. name, application scope, composition):

• Must match the details in NMPA registration documents, certificate and IFU
• Must be legal and truthful
• Must not mislead or deceive users

Disclaimers necessary:

• Personal use devices:g. ‘Please read the instructions before using the device’ or ‘Please seek the advice of a healthcare professional when buying and using this device’
• If safety instructions & precautions are mentioned in NMPA certificate, they must be displayed clearly in the advertisement

e.g. ‘Please read carefully the precautions before using the device’Approval number of the advertisement:

• Must be clearly indicated in the advertisement

For further information on the above topic, please contact us.

On 10.09.2019, the NMPA (National Medical Products Administration) announced changes to the procedures regarding cosmetics sample tests in China (No. 72-2019), followed by an interpretation of their announcement on 12.09.2019. Laboratories - that perform sample tests for cosmetics NMPA approval - need to re-apply for their qualification as a testing institutions because the relevant qualification will be automatically suspended on 01.11.2019. Until then - during the transitional period - there are two possible methods for managing tests. Cosmetics enterprises can follow the original procedures offline, as well as apply for sample tests online. Starting on 01.11.2019, however, laboratories have to be newly accredited. Furthermore, cosmetics enterprises and their NMPA Legal Agents will only be able to apply for and manage tests, which are related to cosmetics registration/filing, online.1) The goal is to improve the testing workflow, to standardize the test project requirements, to improve the efficiency of tests, and to provide strong technical support for cosmetics safety supervision.2) The prerequisite for testing institutions is to submit relevant information and obtain a new certification from the CMA (China Inspection Body and Laboratory Mandatory Approval).3) New guidelines for testing institutions include that testing must not be subcontracted, quality management system has to be ensured, testing work procedures for cosmetics registration and documentations have to be standardized, the facilities and equipment have to meet requirements.4) In order to improve work efficiency, an “Inspection Information System” was introduced to optimize the workflow of testing institutions. Via the online system, cosmetics manufacturers select a testing institution, submit relevant product information and apply for testing. The testing institution can then accept the test application and issues the test report online after testing.5) Changes in managing test samples include:Firstly, rather than regulatory authorities performing the on-site test sample sealing, the testing insitution seals the test samples. This change only applies to domestic “special” cosmetics.Secondly, laboratories accept samples produced for the purpose of testing if the product is not sold yet. (Please note, however, that the NMPA requires a product to be already sold in the country of origin.)6) The test requirements are changed to emphasize the safety of products during evaluation and some test items will be adjusted to better reflect the safety situation of products; for instance, by measuring dioxane.7) During the transition period – until 31.10.2019:Firstly, testing institutions should apply for their qualification because on 1 November, the old ones will be terminated.Secondly, already approved cosmetics, whose tests do not comply with the new specifications anymore, have to undergo supplementary testing a year of the announcement.Third, cosmetics manufacturers can follow the old (offline) way of applying for and managing tests, as well as the new “online” way.

From 01.01.2020, every products must have a Marketing Authorization Holder (MAH), which is responsible for the entire supply chain, including the production and distribution of the product.This information is misleading. In China, the MAH is the manufacturer himself. The foreign manufacturer/MAH must authorize a legal representative in China as his NMPA Legal Agent.

In accordance with the NMPA (National Medical Products Administration) publication No. 66-2019, the UDI (Unique Identification System) will be mandatory for medical devices in China as of 01.10.2019.There are currently the following two relevant guidelines:• Rules for the Unique Identification System of Medical Devices• YY / T 1630-2018 Fundamental Requirements for UDI The UDI code application has to be submitted to ANCC (Article Numbering Center of China). Starting 01.10.2019, the registered UDI code has to be provided to the NMPA as part of initial registration, renewal or change applications. Prior to exporting to China, all newly registered products must be labeled with the UDI code.

On 20.08.2019, the SAMR (State Administration for Market Regulation) announced that the health food regulatory framework will significantly change (No. 13-2019). Companies and individuals will be able to propose to the SAMR to add ingredients to the directory of health food raw materials and to increase the list of approved functional claims. These measures will take effect on 01.10.2019. The procedure under the old regulatory framework led to stagnation and did not produce major changes to the list of approved functional claims or health food raw materials.As reported before, on 28.03.2019, the SAMR had requested public feedback on three major adjustments to health food function claims. The proposed modification of 18, cancellation of 21 and analysis of 6 health function claims.

On 01.08.2019, the NMPA released a notice changing the consultation service of the “National Institute for Food and Drug Control” regarding cosmetics approval applications (No. 245-2019).1) Questions regarding the technical review of cosmetics, on-site consultation is available every Tuesday afternoon.2) Questions regarding the administrative/format review of cosmetics, telephone consultation is available all day on Tuesdays and Thursdays.

On 01.08.2019, the CMDE (Center for Medical Device Evaluation), published a revised “Clinical Trial Exemption List for Medical Devices”. 101 Class II and 41 Class III medical devices were added. The new clinical trial exemption list contains a total of 996 medical devices now. With regards to IVDs, 420 of class II and III IVDs are exempted.