Quality management is a key issue in Japan’s medical markets. Japan quality control and quality assurance requirements are often more stringent than those in the West, and many Japanese quality standards and regulations have different names and content from similar Western regulations. Please keep in mind that even if a facility complies with international standards, that does not mean it complies with the stringent Japanese requirements.
Pacific Bridge Medical’s quality system consultants can advise your company on ensuring that your Japanese operations are compliant with the appropriate quality standards. We conduct mock audits to prepare your facility for a Pharmaceuticals and Medical Devices Agency (PMDA) inspection. Our audits will ensure that your medical device or pharmaceutical facility adheres to all the Japan quality control standards as well as to international standards. We can also act as your Accreditation of Foreign Manufacturers (AFM) representative and assist you with the AFM process.
JAPAN QUALITY CONTROL/QUALITY ASSURANCE FOR MEDICAL DEVICES
In Japan, medical device applicants for product registration must demonstrate Quality Management System (QMS) and Foreign Manufacturer Accreditation (FMA) compliance along with their dossier submission.
- What are Japan’s QMS requirements?
Japan’s QMS requirements involve a QMS certification system that will be conducted according to product groups, not individual products. A single application that covers the entire production process from product design/development to release of the product to the Japanese market must be submitted.
As of 2015, Japan is a participant of the Medical Device Single Audit Program (MDSAP), an international partnership between Japan, the U.S., Australia, Brazil, Canada, and the EU. It allows a single MDSAP audit report to substitute for individual country manufacturing requirements, and unites QMS standards on a global scale.
- Is a QMS audit completed on-site?
A QMS audit may be a paper audit or an on-site audit. In most cases, the audit is conducted via documents. However, for higher risk medical products, the PMDA is more likely to visit the foreign facilities in person. Japanese QMS standards are closely based on ISO 13485 standards, but have a few distinct differences. Ministerial Ordinance 169 is the main regulation specifically listing QMS requirements. Physical on-site audits for QMS compliance are required for some Class III and most Class IV medical devices.
- Do QMS audits only cover manufacturing facilities?
QMS audits also cover other facilities besides the manufacturing facilities, such as the contract sterilization facility, contract testing facility, and contract design facility. The PMDA or a registered certification body will conduct audits of all relevant facilities submitted within one single application.
JAPAN QUALITY CONTROL/QUALITY ASSURANCE FOR PHARMACEUTICALS
- In Japan, Good Manufacturing Practice (GMP) for drugs is referred to as Japanese GMP, or J-GMP. Other Japan-specific pharmaceutical/drug quality standards include the following: Good Quality Practice (GQP), Good Vigilance Practice (GVP), Good Clinical Practice (GCP), and Good Post-marketing Study Practice (GPSP).
- Finding updated official translations of Japanese GMP regulations is difficult. Many English translations will not have the latest version, and understanding the nuances can be tricky. To ensure full compliance, having experts such as Pacific Bridge Medical who can interpret key regulations and meet with the MHLW or PMDA on your behalf is crucial.
ACCREDITATION OF FOREIGN MANUFACTURERS (AFM) IN JAPAN
- What is Accreditation of Foreign Manufacturers (AFM)?
A company that intends to manufacture drug products, quasi-drugs, active pharmaceutical ingredients (APIs), or medical devices overseas and import them into Japan must be certified by the Ministry of Health, Labour and Welfare as an Accredited Foreign Manufacturer (AFM). For medical devices, all foreign manufacturers of Class II or higher medical devices must receive AFM accreditation before their products can be registered in Japan. AFM was formerly referred to as Foreign Manufacturer Accreditation (FMA).
- What occurs during the AFM process?
The AFM process involves an audit by Japanese regulatory officials. All facilities that are responsible for manufacturing are assessed in order to confirm that the foreign manufacturer is able to participate in the product registration process. Applicants submit details such as floor plans and the resume of the person responsible for the manufacturing operations. AFM audits are typically carried out via documentary inspections, although there have been a few on-site inspections in the past.
Contact us today for a free consultation on your specific Japan quality control/quality assurance or AFM needs.
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