J-GMP is a set of ISO13485 that medical device enterprises entering the Japanese market must meet and attach special requirements of Japanese laws and regulations based on quality management systems requirements: 2016. Mainly includes:
1. Japan J-GMP restricts the deletion of articles. MHLW Notice No. 84 it is stipulated that manufacturers of any equipment shall not delete the design control. MHLW Notice No. 77 it is stipulated that manufacturers of any equipment shall not delete the installation control. Japan (MHLW): Class 1 equipment does not need to meet the requirements of MHLW MO169:30-36, which is equivalent to the design and development requirements in ISO13485 [MHLWMO169:4.1].
2. Japan J-GMP has more detailed requirements for keeping records. The storage period of relevant records/invalid documents of the equipment specified in MHLW Notice No. 78 is 15 years, and the storage period of relevant records/invalid documents of other equipment is 5 years. The retention period of training records is 5 years. The equipment-related quality management system documents and records shall be retained for the following periods (training records and documents shall be at least 5 years).
(1) "specially designated medical devices with maintenance and control requirements" 15 years [if the shelf life of the product exceeds 15 years, the time is added to 1 year or more];
(2) products other than "specially designated medical devices with maintenance and control requirements" are 5 years [or the shelf life of the products exceeds 5 years]
3. Japanese J-GMP have more detailed and clear requirements on environmental control than ISO13485. If the requirement is necessary, the enterprise should have dust, humidity, insects and rodent control measures, and should have toxic gas disposal measures. If the products are liquid, Sol and powder, the workshop should close doors and windows, control microorganisms, avoid sewer pollution, and have no channels directly connecting to the outside world.
4. Japan J-GMP stipulates that when an enterprise knows that its product is related to an accident/potential disaster, it shall notify MAH (according to Japanese regulations, MAH shall be responsible for the accident report). The personnel who operate the registered production base do not directly report any adverse events to the regulatory authorities, instead, report any adverse events that meet the standards stipulated in the enforcement regulations of Article 228-20.2 of "P & MD Act" to the MAH marketing license holder. MAH has direct responsibility for not reporting adverse events in a timely manner during the process.
The difference between J-GMP review and ISO13485 certification is:
1. After the ISO13485 certification is passed, the enterprise will get a certificate valid for 3 years. However, after passing the examination on J-GMP, the enterprise does not have a certificate (TWSUDJapan will send a confirmation letter to the enterprise, which is not a certificate or legally required). The audit report issued by the auditor is evidence that the enterprise meets the requirements of J-GMP. Within 2 years of the date of issuance of the report, the enterprise can apply for the product certificate.
2. ISO13485 certification requires supervision and audit every year, while J-GMP only needs 2 supervision and audit within 5 years after the first audit.
Selected from: Medical Device Innovation Network
