MedTechbloggen

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.”