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Drug Approval Certificate No Longer Needed for Combination Product Registration

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drug device combination product

Manufacturers have long been concerned that when applying for drug-device combination product registration, in addition to original country approval for the combination product, the submission of certificates of the drug, from both the original country and China, are also necessary.

However, some combination products contain ingredients that are not subject to drug management or are not developed as a single entity of drug. Also, the combination products often use raw materials with dosage and mode of action different from independently marketed drugs. Therefore, some combination products listed overseas have difficulties being registered in China.

NMPA New Guideline

On July 27, 2021, NMPA issued the “Notice Regarding Drug-Device Combination Products Registration”, addressing the issues above:

  • The drugs contained in imported combination products do not have to be separately registered in China or country-of-approval
  • The registration requirements for combination products with primary mode of drug shall be consistent with the those of drugs
  • The registration requirements for combination products with primary mode of device shall be consistent with the those of device
  • For drug or device contained in combination product that has been approved in China or the original country, the registration certificates should be submitted
  • For drug or device contained in combination product that has not been approved in China or the original country, the registration certificates do not have to be submitted.

The notice also classifies that, if the applicant cannot determine its management category, it should apply to the Standards Management Center for the classification. Manufacturers can also refer to the previous categories, the NMPA published Classification Results.

The functional departments of NMPA, classification process, time limit, and application materials requirements have all undergone significant changes. For the detailed information on how to classify and register your combination products, please email info@ChinaMedDevice.com.

For the latest classification results released on July 7, 2021, please click HERE.

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