MedTechbloggen

Kosmetik i Kina. Nya guidelines utgivna av SFDA.

“In order to meet the needs of administrative licensing for cosmetics, intensify supervision on the naming of cosmetics, ensure scientific and standardized naming of cosmetics, and protect the rights and interests of consumers, the State Food and Drug Administration (SFDA) formulated and issued Requirements on Naming of Cosmetics and Guide to the Naming of Cosmetics in accordance with Regulations Concerning the Hygiene Supervision Over Cosmetics and the rules for the implementation of the Regulations.

To better implement Requirements on Naming of Cosmetics and Guide to the Naming of Cosmetics, SFDA released Notice on Issues Concerning Implementation of Requirements on Naming of Cosmetics and Guide to the Naming of Cosmetics.”

Som ren information bjuder MedTechbloggen på en sammanfattande information om 2010 års Kininesiska Pharm:

2010 Chinese Pharmacopoeia, the 9th edition of the Pharmacopoeia of the People’s Republic of China, contains a total of 4567 monographs, including 1386 new admissions; in Volume I, it contains 2165 monographs of Chinese materia medica and prepared slices of Chinese crude drugs, vegetable oil/ fats and extractives, traditional Chinese patent medicines and simple preparations, with 1019 new admissions, and 634 revisions; Volume II includes 2271 monographs of chemical drugs, antibiotics, biochemical preparations, radiopharmaceuticals and excipients, with 330 new admissions and 1500 revisions; Volume III contains 131 monographs of biological products, with 37 new admissions and 94 revisions; and there are 47 new admissions and 154 revisions in the Appendix.

Pressrelease från Kinesiska Läkemedelverket, berör både Medicinteknik och Läkemedel:

“In order to strengthen the supervision and management to medial sodium hyaluronate (hyaluronic acid sodium) products, further standardize the application and approval procedure and ensure the safety and effectiveness of drugs and medical devices, the State Food and Drug Administration (SFDA) recently released an announcement on management classification of medial sodium hyaluronate in accordance with Drug Administration Law of the People’s Republic of China, Regulations for Supervision and Administration of Medical Devices

According to different clinical applications (indications), the announcement defines the management to medial sodium hyaluronate (hyaluronic acid sodium) products: Products with definite pharmacological effects for the treatment of arthritis, xerophthalmia and skin ulcer shall be managed as pharmaceuticals; Products used in ophthalmic operation aiding, surgical adhesion prevention and tissue augmentation shall be managed as medical devices.”

Nytt från Kina;

“In order to intensify supervision on medical device manufacturing, standardize quality management systems for medical device manufacturing, strengthen the management of medical device GMP inspection, in accordance with Regulations for Supervision and Administration of Medical Devices and other related regulations, the State Food and Drug Administration (SFDA) formulated Good Manufacturing Practice for Medical Devices (interim) and Requirements for Medical Device GMP Inspection (interim).

Good Manufacturing Practice for Medical Devices (interim) comprises 13 chapters, 69 articles and will take effect as of January 1, 2011.”

MedTechbloggen förmedlar information från det “kinesiska Läkemedelsveket”:

“The State Food and Drug Administration (SFDA) formulated Medical Device GMP Detailed Rules for Sterile Medical Devices (interim), Medical Device GMP Inspection Standards for Sterile Medical Devices (interim), Medical Device GMP Detailed Rules for Implantable Medical Devices (interim) and Medical Device GMP Inspection Standards for Implantable Medical Device (interim) and recently issued notices on relevant requirements, for the purposes of enforcing Good Manufacturing Practice for Medical Devices (interim), standardizing the production quality management systems and the supervision and inspection of sterile medical devices and implantable medical device.”

“Since soliciting opinions on revised Good Manufacturing Practice for Pharmaceutical Products (draft for comment) in September 2009, the State Food and Drug Administration (SFDA) has received timely feedback from all-walks of life in the society. On the basis of the feedback, SFDA organized the re-revision of Good Manufacturing Practice for Pharmaceutical Products (draft for comment). The revised Good Manufacturing Practice for Pharmaceutical Products (2nd draft for comment) and the appendix are now soliciting public opinions. Opinions shall be provided in written form to the Department of Drug Safety & Inspection of SFDA before December 20, 2009.”

Säljer du infusionspumpar på Kina kan det vara bra att titta närmare på detta:

The State Food and Drug Administration (SFDA) released the third issue of 2009 National Medical Device Quality Announcement on November 17,2009 and publicized the quality sampling and testing results of disposable infusion pumps.

Kina stramar upp klassificeringen av munskydd:

“Recently, the State Food and Drug Administration (SFDA) issued notice on clarifying the standards and rational usage for medical face mask.

The notice says that medical face mask belongs to class Ⅱ medical device; All the food and drug regulatory departments at provincial level should enhance administration on the standards of the medical face masks in their jurisdiction, require the companies manufacturing as standards, and give guidance to the medical institutions and the public using rational medical face masks.

The medical face mask containing antiseptic, antiblastic or antiviral components belongs to class Ⅲ medical device. At present, no approval concerning such products has been given by SFDA. Any companies who want to manufacture and market the products must obtain the registration certificate for medical device from SFDA.”

Pressmeddelande från den kinesiska läkemedelsmyndigheten:

“Recently, the State Food and Drug Administration (SFDA) issued notice on clarifying the components of drug-containing devices, the matters on application and registration for drug-containing devices, and the responsibilities of the departments for accepting application and registration.

The new notice went into effect as the date of its promulgation. The Notice on Matters Relating the Registration of Drug-containing Device (Guo Shi Yao Jian Ban [2004] No.94) which came into forth in 2004 was abolished.”

MedTechbloggen har vid flera tillfällen smågnällt eller påpekat att tandtekniker och tandläkare har mindre bra kunskaper (är dåliga på) det medicintekniska regelverket. Det visar sig nu att vi, tyvärr, har haft rätt. Läkemedelsverket har granskat ett antal svenska tandtekniska laboratorier. I rapporten från Läkemedelsverket 2009-11-07 konstaterar Mats Ohlson och Nils Bäckman att laboratorierna håller en hantverksmässigt hög klass. Kunskapen om det medicintekniska regelverket är dock mindre bra. I sammanfattningen säger Läkemedelsverket: “Inspektionerna gav vid handen att kunskapen om regelverkets krav i de flesta fallen fortfarande är bristfällig. Innebörden av laboratoriets ansvar som tillverkare och vad det medför var dåligt känd. Även om bristerna i förstone kan uppfattas som rent byråkratiska har de en avgörande betydelse för säkerheten hos de tillverkade produkterna. En hel del tid ägnades därför åt att förklara att regelverkets krav förvisso är obligatoriska men att laboratoriet även har god praktisk nytta av att känna till och följa regelverket och hur det i slutänden gagnar patienternas intresse och säkerhet.”
En annan aspekt som MedTechbloggen tagit upp vid några tillfällen är importen från Fjärran Land. Läkemedelsverket sammanfattar: “Import av arbeten från underleverantörer i länder utanför EU är en företeelse som har ökat. Detta har skapat en viss osäkerhet i branschen om säkerheten och hur man kan kontrollera om ställda krav är uppfyllda. En särskild fråga är hur laboratoriet eller importören förvissar sig om säkerheten på ingående material. Diskussionen om ev. hälsoeffekter av ingående material har intensifierats efter att man i USA i ett TV‐program hävdat att man funnit bly i ett tandtekniskt arbete tillverkat i Kina.”
Självklart ställer NMA upp och producerar och genomför utbildningar om regelverket och standarder som berör de tandtekniska laboratorierna. NMA har mycket stor erfarenhet inom området. Du får lätt kontakt via NMAs hemsida.