In order to further implement the requirements of high-quality development and strengthen the supervision of new products of measuring instruments, in accordance with the provisions of laws and regulations such as the Measurement Law of the People's Republic of China and the Implementation Rules of the Measurement Law of the People's Republic of China, the State Administration for Market Regulation has revised and issued the "Measures for the Administration of New Products of Measuring Instruments" (Order No. 68 of the State Administration for Market Regulation, hereinafter referred to as the "Measures"). The relevant content is now interpreted as follows:

1、 What is the background of the revision of the Measures?  

The Measures were first formulated in 2005 and have been implemented for nearly 18 years, playing an important role in standardizing the approval system for measuring instrument types. Over the years, with the continuous development of the economy and society, the State Administration for Market Regulation has been committed to promoting the reform of the administrative approval system in the field of metrology, continuously optimizing the system design. Some provisions in the Measures are no longer suitable for the needs of metrology management practice, and further adjustments and improvements are needed in the acceptance, evaluation, approval, and post supervision of the type approval of measuring instruments. By revising the 'Measures', we aim to better implement the requirements of the' Measurement Development Plan (2021-2035) ', strengthen the management of new measuring instrument products, and promote high-quality economic and social development.  

2、 How to adjust the scope of measuring instruments applicable to the Measures?   

In 2019, the State Administration for Market Regulation formulated and released the "Catalogue of Measuring Instruments Subject to Compulsory Management", which was revised in 2020. The original "Catalogue of Measuring Instruments Subject to Legal Management in the People's Republic of China (Type Approval Part)" (General Administration of Quality Supervision, Inspection and Quarantine Announcement No. 145 of 2005) and "Catalogue of Type Examination of Imported Measuring Instruments in the People's Republic of China" (General Administration of Quality Supervision, Inspection and Quarantine Announcement No. 5 of 2006) were abolished, and the catalogue of measuring instruments that require type approval or import type approval was redefined. The Measures adjust the scope of applicable measuring instruments accordingly, stipulating that "producers who manufacture new measuring instruments listed in the Catalogue of Measuring Instruments Subject to Compulsory Management for the purpose of sales, and whose supervision method is type approval, shall obtain type approval from the provincial market supervision and management department before putting them into production. Producers who manufacture measuring instruments other than those mentioned in the preceding paragraph may voluntarily entrust capable technical institutions to conduct type tests as needed. New standard substance products shall be subject to relevant regulations on standard substance management." Currently, the Catalogue of Measuring Instruments Subject to Compulsory Management is implemented in accordance with the Announcement of the State Administration for Market Regulation on Adjusting the Catalogue of Measuring Instruments Subject to Compulsory Management (Announcement No. 42 of the State Administration for Market Regulation in 2020).  

3、 What new requirements does the 'Regulations' put forward for type evaluation?  

The Measures have added requirements for applicants to keep prototypes, requiring them to keep sealed and marked prototypes and confidential technical information. For series products, at least one representative product prototype should be kept; For a single specification product, at least one prototype should be kept. The retention period shall not be less than five years from the date of cessation of production of the type of measuring instrument. At the same time, the Measures will increase the period for technical institutions responsible for type evaluation to retain relevant information and original records after type evaluation from three years to five years, thereby providing better support for product consistency judgment in subsequent management.  

4、 How does the 'Regulations' reflect the uniformity of form evaluation?  

In order to unify the national standards for type evaluation and avoid unfair competition caused by regional differences, the Measures have abolished the content that type evaluation institutions can prepare type evaluation outlines based on the technical specifications for type evaluation, and clarified that type evaluation should be conducted in accordance with the technical specifications for type evaluation issued and implemented by the State Administration for Market Regulation. If the national metrological verification regulations have already stipulated the requirements for type evaluation, the regulations shall be followed. If there is no national technical specification for type evaluation, the technical institution responsible for type evaluation shall draft the technical specification for type evaluation based on relevant standards, specifications or international recommendations, and implement it after being reviewed and approved by the relevant national professional metrology technical committee.  

5、 What new requirements does the Measures put forward for the production of new measuring instruments?   

On December 27, 2017, the Standing Committee of the National People's Congress deliberated and passed the Decision of the Standing Committee of the National People's Congress on Amending the Law of the People's Republic of China on Tenders and Bids and the Metrology Law of the People's Republic of China, canceling the "License for Manufacturing and Repairing Measuring Instruments", and the AQSIQ abolished the "Measures for the Supervision and Administration of the License for Manufacturing and Repairing Measuring Instruments" accordingly. In order to further strengthen the supervision and management of the production of new measuring instruments and ensure the quality of measuring instrument products, the Measures have added multiple requirements. For manufacturing measuring instruments that have obtained type approval, the nationally standardized type approval mark and number should be marked in their user manual. The second method is to manufacture measuring instruments through commissioned processing. The commissioned party shall obtain the corresponding type approval for the commissioned measuring instruments and sign a written commission contract with the commissioning party. The measuring instruments for commissioned processing shall be marked with the names and addresses of the commissioning party and the commissioned party, as well as the type approval mark and number of the commissioned party. Thirdly, producers should have facilities, personnel, and calibration equipment that are suitable for the measuring instruments they manufacture, and be responsible for the measuring instruments they manufacture to ensure that their measuring performance meets relevant requirements. Encourage producers to establish a comprehensive measurement management system and voluntarily apply for measurement management system certification.  

6、 How does the Measures reflect the strengthening of in-process and post event supervision?  

In order to further strengthen the in-process and post supervision of new products of measuring instruments, the Measures stipulate that the State Administration for Market Regulation is responsible for the unified supervision and management of new products of measuring instruments nationwide, and the provincial market supervision and management departments are responsible for the supervision and management of new products of measuring instruments in their respective regions. In addition, they specifically require local market supervision and management departments at or above the county level to supervise and inspect the quality of manufactured measuring instruments, the consistency between actual manufactured products and approved types, in accordance with relevant national regulations, in order to ensure that the requirements for approval of measuring instrument types are implemented.  

7、 What improvements and supplements have been made to the relevant legal responsibilities in the Measures?  

The current "Metrology Law" and "Detailed Rules for the Implementation of the Metrology Law" have relatively brief provisions on illegal activities in the process of manufacturing and selling new products of measuring instruments, with low administrative penalties and weak deterrent effects. The original "Measures" did not provide for any other legal responsibilities, except for citing the penalty provisions of the "Metrology Law" and the "Implementation Rules of the Metrology Law". In view of this, the Measures, based on the relevant provisions of the Legislation Law, the Metrology Law, and the Implementation Rules of the Metrology Law, have added three administrative penalties for three illegal acts: failure to mark the type approval mark and number as required, manufacturing and selling measuring instruments that are inconsistent with the approved type, failure to continuously meet the type approval conditions, and no longer having facilities, personnel, and calibration equipment that are suitable for the manufactured measuring instruments. The types and amounts of penalties have been set in accordance with the provisions of the Administrative Penalty Law, and the punishment intensity has been increased. At the same time, new transfer clauses will be added to connect with the product quality supervision and spot check system, and comprehensive supervision of the approval of measuring instrument types will be carried out.

(Source: State Administration for Market Regulation)

Link to the original text of the "Management Measures for New Products of Measuring Instruments"

https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/fgs/art/2023/art_8f47e47edcff49e9a2eb2bab7b74fca9.html