BSI has identified the top 22 ordinances, notifications and memorandums which are fundamental to navigating the regulatory process of the Japan PAL.
Ministerial Ordinances
Question:
In various presentations about the new Japan PAL, there is a reference made to “GMP” requirements, but we have also seen references to “QMS” requirements. Are “GMP” and “QMS” used interchangeable?
In Japan, “GMP” means Good Manufacturing Practices and applies to manufacturers of drugs and quasi-drugs. “QMS” means Quality Management System and applies to manufacturers of medical devices and IVD reagents. To differentiate between drug and device manufacturers, “GMP” and “QMS” should not be used interchangeably.
Question:
Ministerial Ordinance No. 169 appears to describe the general QMS requirements for a medical device manufacturer. Does this document apply to all locations for all device classifications?
GMP (MHLW Ministerial Ordinance No.169, 2004) is required for all manufacturing locations for class IV, III, and II medical devices, and those Class I medical devices specifically designated by MHLW. BSI Japan, as part of the product certification process, will conduct assessments for Designated Control Medical Device (i.e., eligible Class II devices), as designated by MHLW in accordance with this ordinance.
Chapter 2 of this ordinance stipulates the requirements for general medical devices, whereas chapter 3 stipulates requirements for the manufacturer of Japanese importers of medical devices conducting labeling, testing, storage, etc. Chapter 4 stipulates the requirements for Biological-origin Medical Devices and chapter 5 stipulates the requirements for In-Vitro Diagnostic Reagents.
Question:
We are a manufacturer of IVD Reagents and Ministerial Ordinance No. 169, Article 80, is confusing with respect to the QMS requirements. What exactly is required?
Article 80 describes the QMS requirements for manufacturers of IVD Reagents and contains a statement that the provisions of “Chapter 2 and Chapter 3 shall be applied mutatis mutandis”, meaning that all requirements of the articles in these two chapters (i.e., Article 3 through Article 72) are applicable to manufacturers of IVD Reagents, with specific modifications as indicated in Article 80.
Question:
Ministerial Ordinance No. 2 contains additional building and environmental requirements for drug, cosmetic and device manufacturers (includes extra requirements for sterile and biological devices). Do these requirements, along with Infrastructure Requirements from Ordinance 169, apply to all medical device manufacturers?
The short answer is YES. Specifically, requirements exist for building and environmental controls in both ordinances which the manufacturer of medical devices must meet. In Ordinance No. 2, the requirements for medical devices are indicated in Section 4, Articles 14 to Article 14-4. These requirements apply to all medical device manufacturers and must be meet in order to obtain either the domestic Japanese Manufacturer’s license or MHLW accreditation as a Foreign Manufacturer. While assessment to the requirements of Ordinance 169 may be done by BSI as part of the product certification process, assessment of compliance to Ordinance No. 2 shall be conducted by PMDA and not by any of the Registered Certification Bodies.
Question:
Ministerial Ordinance No. 136 appears to be the requirements to MAH (the importer/distributor in Japan). Do these requirements apply only in Japan?
The Good Quality Practices (GQP) specified in MHLW Ministerial Ordinance No.136, 2004 are requirements for the MAH located in Japan, i.e. the distributors and the importers in Japan, and not requirements for either the Japan or overseas manufacturers. The assessment of compliance to the GQP, for each MAH, is conducted by the prefectural government where the MAH has their registered place of business. Every manufacturer should familiarize themselves with the requirements of this ordinance, because of the specific requirements stipulating the cooperation between the MAH and the medical device manufacturer.
Question:
The requirements of Ministerial Ordinance No. 136 seem very limited for the MAH and only pertain to records. Is this true?
The requirements for each MAH responsible for medical devices are stipulated in Article 1, Article 2 and from Article 21 to Article 25. In Article 25, there is a description of “Provisions to be applied Mutatis Mutandis”, i.e. Article 25 quotes from Articles 3 - 16. Therefore, the requirements of Article 3 to Article 16 are applicable, although some excluding items are indicated specifically. Therefore, the GQP requirements are not only concerned with the records which must be kept by the MAH. The GQP requirements include all other requirements indicated in the above articles.
Question:
Would BSI conduct assessments against all of these documents where the products are within the scope of the third party program?
BSI Japan will conduct QMS assessments according to Ordinance No. 169, and only for those eligible Class II devices. Currently, there are a total of 1,785 different devices which MHLW has classified as Class II device, and within our accreditation as a Registered Certification Body, BSI Japan provides product certification for 776 which are Designated Control Medical devices. As other devices become eligible, BSI will be able to conduct the QMS assessments for those products. A QMS assessment, according to Ordinance No. 169, for all Class IV and Class III devices, and those designated Class I devices, will be conducted by PMDA. Other Class I devices are exempt from QMS certification.
Assessments of manufacturers, according to Ordinance No. 2, are conducted by PMDA and assessments of MAH, according to Ordinance No. 136, are conducted by the Japan Prefectural Government.
For further information on Japan's Pharmaceutical Affairs Law and QMS requirements, please email us at sales.japan@bsigroup.com or contact BSI Japan on+81-3-6890-1177.
