Obtaining a drug inspector certificate

Updated: July 2024, 9

What is a drug inspector certificate?

A medical inspection certificate is a certificate required at customs when importing medical devices into Japan that are not for commercial purposes (such as selling or giving to others) but are used for treatment by individuals or doctors and have not yet gone through approval or certification procedures in Japan.

　

You must apply for and receive certification from the Health and Welfare Bureau, which has jurisdiction over the drug.

At Support Administrative Scrivener Corporation, we support the application for this Yakusin Kan certificate.

Cases where a drug inspector certificate is required

① When importing for personal use

 If an individual brings or imports more than a certain amount of medical devices into Japan, a drug inspector certificate must be presented at the time of customs clearance.

② When importing for use by doctors, etc. for treatment

 When applying for approval under the provisions of the Pharmaceutical Affairs Law, if you are conducting testing and research (excluding clinical trials) such as preparing test results to be attached, or if you are importing medical devices as in-house samples (samples intended for the importer to use to judge the commercial value, etc., and not intended to be distributed to third parties even free of charge for market development, etc.), you will need to present a Pharmaceutical Inspection Certificate at customs clearance.
However, only the importer can use the imported items for diagnosis, treatment, etc.

If the product needs to be used by multiple doctors within the same medical institution, each doctor will need to act as the importer and complete the import procedures as separate cargo.

③ When importing for use in clinical trials

In the following cases, it is necessary to present a drug inspector certificate at the time of customs clearance.

・When a company (sponsor) imports the product for use in a clinical trial conducted mainly by the company (sponsor)

・Companies need to confirm the quality of drugs, etc., and label that they are for clinical trials (hereinafter referred to as "labeling, etc."). When supplying to a sponsor conducting a clinical trial

・When importing by a doctor or dentist for use in a clinical trial conducted mainly by a doctor or dentist

・If a company is required to label drugs, etc., the company imports the drug, labels it, etc., and then supplies it to a doctor or dentist who is primarily conducting clinical trials.

- Regarding unapproved drugs, etc. (excluding drugs, etc. that are subject to clinical trials) used for testing, etc. during clinical trials (for which a clinical trial plan notification has already been submitted to PMDA), If a company is required to label the drug, etc., the company imports it, labels it, etc., and then supplies it to another company (sponsor) that will primarily conduct the clinical trial.

Excludes cases where a clinical trial plan notification has been submitted to PMDA

④When importing for the purpose of testing and research, etc.

In the following cases, it is necessary to present a drug inspector certificate at the time of customs clearance.

・When importing pharmaceuticals, medical devices, quasi-drugs, cosmetics, in vitro diagnostic drugs, or regenerative medicine products for the purpose of testing and research by corporations (companies, etc.), research institutes, universities, etc.

・When a corporation (company, etc.), research institution, university, etc. imports pharmaceuticals, medical devices, quasi-drugs, cosmetics, in vitro diagnostic drugs, or regenerative medicine products as internal samples.

・When a corporation (company, etc.), research institution, university, etc. imports a poisonous or deleterious substance for the purpose of use in test research.

・When a poisonous or deleterious substance is imported by an individual researcher affiliated with a research institution, university, etc. for the purpose of use in test research.

⑤ When importing for exhibitions

 When displaying medical devices for the purpose of improving and developing academic research, promoting science and technology, or promoting industry at exhibitions sponsored or sponsored by academic societies, public institutions, etc., a pharmaceutical inspector certificate must be presented at the time of customs clearance. .

⑥ When importing materials to be used as raw materials for our own products

Contact Us

At Support Administrative Scrivener Corporation, we provide application support and consulting regarding the Pharmaceutical and Medical Device Act, from those newly entering the medical device industry to existing marketing distributors, manufacturers, and distributors.

Applications for medical devices are highly specialized and can be said to be one of the fields in which there are few administrative scriveners who can handle them.

Our staff has a track record of applying in all prefectures across the country. Please contact us by all means.

Our dedicated staff handles cases nationwide.