Since the medical instrument regulatory framework was fully implemented in January this year, the industry and doctors have expressed their opinions. The Singapore Health Science Bureau announced yesterday that it has simplified and relaxed the regulatory framework to make the approval process faster and cheaper.
The relaxed framework is expected to help medical device operators save money and ultimately benefit consumers who use medical instruments.
Low-risk Class A medical instruments are subject to approval and no approval. After the framework is relaxed, the Class A medical instruments that can be put on the shelves without approval will increase from the original 2000 to more than 4,700, accounting for 80% of all Class A medical instruments. . Wheelchairs and surgical masks are two types of medical instruments that no longer require approval.
This means that their manufacturer or importer can save 25 yuan in approval fees. The new measures will take effect from next month. The Health Sciences Bureau divides medical instruments into four levels according to their risk level, namely A, B, C and D.
From September, the Health Sciences Bureau will also simplify the approval process for low- and medium-risk Class B medical devices. As long as the instrument has been officially recognized by any of the five countries of the United States, the European Union, Australia, Canada or Japan, and no safety problems have occurred within three years, it will be approved immediately.
There are about 1,750 Class B medical devices that can be approved immediately. The approval fee will be reduced from the current 2,300 yuan to 1,400 yuan, and the operator can save about 40%. If the instrument is only officially recognized by both countries, but does not have a three-year safety record, it can still pass the rapid approval process.
The relaxation and simplification of the approval process does not mean that the patient's safety will be threatened. Associate Professor Lin Jianwei of the Health Science Bureau said: "We will pay more attention to the supervision after the instrument is introduced to the market in order to manage risks."
The authorities also plan to further simplify the approval process for higher-risk C- and D-class medical instruments, such as childcare devices and pacemakers, in the future.
Xu Lianzhen, Minister of Health of the Ministry of Health, also said at the medical instrument industry exchange meeting held yesterday: "There is no rigid regulatory framework, especially in the complex field like medical instruments. Even if the framework is fully launched at the beginning of this year, it will continue to need Constant improvement and adjustment."
The Health Sciences Bureau launched a medical instrument regulatory framework in phases after the Health Care Products Act came into effect in 2007.
From August 2010, all medium and high risk C-class and high-risk D-class medical instruments are subject to mandatory approval. Since January this year, the coverage of mandatory approval has been extended to all low- and medium-risk Class B and low-risk Class A medical devices.
However, since the full implementation of the four months, the industry has raised many concerns. Some doctors believe that the approval of medical instruments is too long, resulting in the latest medical equipment not being able to enter Singapore, preventing patients from getting the latest treatment.
Others worry that the Chinese market is too small, and the extra cost of approving medical instruments may stop foreign manufacturers and limit the types and options of local medical instruments. Some operators have also revealed that after the regulatory framework is fully effective, they have to pay a relatively high approval fee, which has led to soaring prices of instruments.
Shuitech (Asia) Co., Ltd., a director of Smitech (Asia) Co., Ltd., which manages the distribution of medical and dental instruments, said that the price of some small imported low-value medical devices could increase by 50%.
Most operators and doctors welcome the new framework. Chen Guanyan, president of the Singapore Medical Equipment Industry Association, said: "The new framework will reduce the work and costs of applying for medical instruments, and ultimately benefit consumers. The new framework will also promote the long-term development of this industry."
Dr. Zhong Yewei, Vice President of the Singapore Medical Association, and Dr. Li Wenling, an expert in orthopedics at Singapore Medical Group, hope that the new framework will be further improved. Dr. Li Wenling said: "If a large organization such as the US Food and Drug Administration (FDA) or the European Qualified Certification Body has approved an instrument, then we should not repeat the entire process and do redundant administrative work."
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