China Medical Device Registration

17/11/2015

CFDA issues four guidelines for Medical Device Good Manufacturing Practice on-site inspection
To promote the implementation of the Good Manufacturing Practice for Medical Devices, strengthen the supervision and management of medical device manufacturing, and offer guidance to regulatory departments' GMP on-site inspection to medical device manufacturers and evaluation of the inspection results, China Food and Drug Administration (CFDA) recently formulated and issued the Guideline for Medical Device Good Manufacturing Practice On-site Inspection, the Guideline for Medical Device Good Manufacturing Practice On-site Inspection for Sterile Medical Devices, the Guideline for Medical Device Good Manufacturing Practice On-site Inspection for Implantable Medical Devices, and the Guideline for Medical Device Good Manufacturing Practice On-site Inspection for In Vitro Diagnosis Reagents in accordance with the Good Manufacturing Practice for Medical Devices and its related appendixes.

04/09/2015

CFDA issues Guideline for Technical Review of Medical Device Software Registration

On August 5, 2015, China Food and Drug Administration (CFDA) issued the Guideline for Technical Review of Medical Device Software Registration. The Guideline is for guiding manufacturers to submit application documents of medical device software registration and standardizing the technical review requirements for medical device software.

31/08/2015

CFDA issues announcement on further standardizing naming of health food
The revised Food Safety Law of the People's Republic of China will come into effect as of October 1, 2015. In accordance with the requirement of strict supervision to health food, China Food and Drug Administration (CFDA) recently issued the Announcement on Further Standardizing Naming of Health Food to avoid the name of health food products misdirecting consumers, and protect the health of the public

31/08/2015

CFDA issues 130 national standards for drug packaging materials

China Food and Drug Administration (CFDA) recently issued the No. 164 Announcement of 2015, which released 130 national standards for drug immediate packaging materials and containers, including YBB 00032005-2015 "Infusion Bottles Made of Soda Lime Glass" etc. These new standards will be implemented as of December 1, 2015.

28/07/2015

CFDA releases 2014 Annual Report for National Adverse Drug Reaction Monitoring
China Food and Drug Administration (CFDA) recently released the 2014 Annual Report for National Adverse Drug Reaction Monitoring. In 2014, the national adverse drug reaction monitoring network received 1.328 million adverse drug reaction/event (ADR/ADE) case reports, up 0.8% than the previous year, including 341 thousand new and serious ADR/ADE cases (25.7% of the total). ADR reporting coverage rate reached 94.4% at county level; 991 ADR cases, on average, were reported per million people. The Annual Report indicates that China’s ADR reporting coverage was increased, the ability to discover and collect ADR information was enhanced, and the public’s drug safety awareness was further improved.

28/07/2015

CFDA releases 2014 Annual Report for National Medical Device Adverse Event Monitoring
China Food and Drug Administration (CFDA) recently released the 2014 Annual Report for National Medical Device Adverse Event Monitoring, which includes the general situation of medical device adverse event reporting, the statistical analysis of medical device adverse events, and the control measures for the safety issues of urethral catheter, special electromagnetic therapeutic apparatus and fumigation equipment. The report reflects comprehensively the performance of China's medical device adverse event monitoring in 2014

19/06/2015

2015 International Food Safety Conference held in Beijing

On June 15, 2015, the 2015 International Food Safety Conference was held in Beijing, as an important activity of the China Food Safety Publicity Week. Bi Jingquan, Minister of China Food and Drug Administration (CFDA), attended the conference and delivered a speech. Teng Jiacai, Vice Minister of CFDA, presided over the conference.

Representatives from related international organizations and food safety regulatory authorities reached a consensus on international cooperation in food safety, namely to stick to the principles of “win-win cooperation, balanced development and common security”, and make the top-level design for regulatory cooperation to realize global governance of food safety.

UNIDO Director General Li Yong, the Ambassador of the Kingdom of the Netherlands to China Aart Jacobi, WHO Representative in China Bernhard Schwartlander, the World Bank’s Country Director Bert Hofman, FAO Representative Percy Misika, and representatives from the Ministry of Agriculture, the National Health and Family Planning Commission, and the General Administration of Quality Supervision, Inspection and Quarantine of China delivered speeches at the conference. About 300 representatives from the international organizations mentioned above, the food safety regulatory authorities, industrial associations, academic institutions and media of more than 20 countries or regions, including the United States, the Netherlands, Germany, Ireland, Denmark, France, South Korea, Switzerland, European Union, Hong Kong and Macao, attended the conference.

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07/05/2015

CFDA issues 90 industry standards for medical devices

China Food and Drug Administration (CFDA) recently issued the No.8 Announcement of 2015, which released 90 industry standards for medical devices, such as YY 0572-2015 "Water for Hemodialysis and related therapies". These standards include 14 mandatory industry standards and 76 recommended industry standards, involving implants for surgery, medical electrical equipment, in vitro diagnostic reagents, dentistry etc. The issuance of these standards will further improve the medical device standards system of China, help improve the quality of medical devices and promote the sound development of medical device industry.
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03/03/2015

CFDA Vice Minister Wu Zhen meets the Danish Ministry of Health delegation

On January 26, 2015, Wu Zhen, Vice Minister of China Food and Drug Administration (CFDA), met with the Danish Ministry of Health delegation headed by Mr. Per Okkels. Both sides reviewed the friendly cooperation in the field of drug supervision, and exchanged opinions on topics of common concerns such as drug evaluation and approval. Main directors of CFDA’s Department of International Cooperation, relevant directors of Department of Legal Affairs, Department of Drug and Cosmetics Registration attended the meeting.
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Croxxmore is a medical device consultants for helping you access the largest and fastest growing medical device markets in China. We are launching medical device consulting for Sourcing and Manufacturing Solution, Registration and Approval, Supplier Inspection/ QC, In-Country Representation, Medical…

26/12/2014

The Croxxmore Team wishes you Festive Holidays and a Successful 2015. www.croxxmore.com www.croxxmoremed.com

22/12/2014

What Is Wellbutrin in China ?

Wellbutrin is the brand name for bupropion, a prescription antidepressant drug that’s used to treat depression and seasonal affective disorder — a type of depression that usually strikes in the fall and winter.

Under the brand name Zyban, bupropion has also been prescribed to help people quit smoking. Wellbutrin and Zyban, both made by GlaxoSmithKline, should not be taken together.

Available as a standard pill and in a sustained-release or long-acting extended-release tablet, Wellbutrin belongs to the aminoketone class of antidepressants, which are chemically unrelated to the better-known selective-serotonin reuptake inhibitors (SSRIs), such as Prozac, Paxil, or Zoloft.

Wellbutrin mobilizes the brain chemicals norepinephrine and dopamine, but exactly how it works to treat depression is not known.

Doctors have also prescribed Wellbutrin "off label" to treat attention deficit hyperactivity disorder (ADHD), and in tandem with other medications — particularly SSRIs — to treat bipolar disorder.

The Food and Drug Administration (FDA) originally approved Wellbutrin as a treatment for depression in 1985, but it was withdrawn from the market in 1986 amid findings that it increased the frequency of seizures in non-depressed bulimic patients at the originally recommended dose of 400-600 milligrams a day.

The FDA reapproved Wellbutrin in 1989 with a lowered daily dose and a warning about the increased risk of seizures. It approved the sustained-release version of Wellbutrin in 1996 and the extended-release version in 2003. In 2006, Wellbutrin was the first drug the FDA approved for the treatment of seasonal affective disorder.

Wellbutrin (Bupropion) Warnings

Since 2004, Wellbutrin, like other antidepressants, is required to carry a "black box" warning about an increased risk of suicidal thinking and behavior in children, teenagers, and young adults between the ages of 18 and 24, and about the need to monitor patients taking antidepressants for signs of any worsening of their depression, and for the emergence of suicidal thoughts, especially in the first few months of treatment, or when the dose is either increased or decreased.

The "black-box" warning also extended to Zyban, which contains the same ingredient as Wellbutrin and is made by the same company (Wellbutrin is not FDA-approved as a smoking-cessation aid in the United States).

You should tell your doctor about all the prescription and over-the-counter drugs, vitamins, illegal and recreational drugs, and dietary supplements you're taking, especially if you're on monoamine oxidase inhibitors (MAOIs), such as Marplan (isocarboxazid), Nardil (phenelzine sulfate), the antibiotic Zyvox (linezolid), or whether you stopped taking one of these drugs in the 14 days before you begin taking Wellbutrin.

People who have had a seizure or epilepsy, an eating disorder such as bulimia or anorexia nervosa, or are using or withdrawing from alcohol or certain drugs used to treat anxiety, seizures, and insomnia such as Xanax, Va**um, and Ativan, are generally not good candidates for Wellbutrin.

Also be aware that Wellbutrin can cause false-positive urine tests for amphetamines.

Your doctor also needs to know if you have liver or kidney disease (which would require certain precautions), are taking insulin for diabetes, are taking other antidepressants, or are using a ni****ne patch, which can increase the risk of high blood pressure.

Pregnancy and Wellbutrin (Bupropion)

Wellbutrin is in Pregnancy Category C, according to the FDA, which means that harm to a woman’s fetus cannot be ruled out. Nonetheless, the drug’s benefits to the mother may outweigh the potential risks to her developing fetus.

Data from population studies of pregnant women taking Wellbutrin in the first trimester indicated no increased risk of congenital malformations. A 2010 study in the American Journal of Obstetrics and Gynecology suggested a link between Wellbutrin taken in the first trimester and congenital heart defects but found that more data was needed to confirm a connection.

Wellbutrin is present in breast milk, and there’s some evidence that it may cause seizures in babies; it may also reduce the amount of breast milk a mother produces.

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18/12/2014

CFDA Vice Minister Wu Zhen meets the Czech State Institute for Drug Control Delegation

On December 8, 2014, Wu Zhen, Vice Minister of China Food and Drug Administration (CFDA), met with the Czech State Institute for Drug Control Delegation headed by Mr. Zdenek Blahuta. Both sides exchanged opinions on bilateral cooperation in the field of drug supervision, and reached a preliminary consensus on building bilateral cooperation mechanism. Relevant directors of CFDA’s Department of Drug and Cosmetics Registration, Department of Drug and Cosmetics Supervision attended the meeting.

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