China


General

It is important to have a reliable partner in China for the communication with the Authorities. He should have detailed understanding of the regulatory requirements.

 

Classification

The medical deices are classified in three classes 1, 2, 3. Based on the intended use devices will fall under certain product categories listed in the database referencing the individual class.

 

Product Registration

The class I products more or less follow a listing procedure but for the higher classes an intense two stage review by the NMPA is mandatory and require tremendous review fees. Product testing based on Chinese national Standards in Chinese Laboratories is a prerequisite.

 

 

 

Quality System

Although the current regulations do not explicitly require a quality system to be audited by the NMPA prior to the registration of foreign manufacturers' medical devices the Chinese Authorities started a program auditing foreign manufacturers.

 

Specialties

Not only the labeling must be translated into Chinese language but also the manufacturers' names. 

Japan


General

The Japanese PMD Act makes use of many GTHF principles. Unlike other countries it is mandatory to have a Marketing Approval Holder (MAH) in Japan.

 

 

Classification

For the classification into the classes I, II, III, and IV the Japanese PMD Act uses and references the GHTF classification rules.

 

 

 

Product Registration

The Japanese regulatory system includes three different procedures for product registration:

- todokede (notification)

- ninsho (certification)

- shonin (approval)

Based on the review results and the QMS inspection a Marketing Authorization will be granted to the Japanese partner.

 

Quality System

In order to comply with the quality system of the Ordinance 169 requirements in Japan the manufacturer as well as his MAH need to be covered e.g. by a MDSAP audit.

 

 

 

 

Specialties

The registration fees for high class products with new technologies are extremely high.

 

Taiwan


General

For manufacturers in Europe and the USA the so called Technical cooperation program
(TCP-II) simplifies procedures for QM compliance.

 

Classification

Taiwan is using a three class approach
(Class 1, 2, 3)  similar to the US-FDA classifications.

 

 

 

Product Registration

Prior to entering the market the authorities and experts a performing a review of the dataset submitted by the manufacturer based on the class of the medical device.

 

 

 

 

 

 

Quality System

The quality system requirements in Taiwan are GMP based and as such comparable to the requirements of the ISO 13485:2016.

Part of the approval procedure is provision of evidence for compliance - either audit based under TCP-II or paper based - to the taiwanese GMP requirements.

 

Specialties

The application of the TCP-II approach requires the European manufacturer to have a cooperation with one of the Notified Bodies being accepted under this program.

 


Malaysia


General

The Malaysian system for registration of medical devices is well developed, easy to follow up and database driven.

 

Classification

Four Classes 1,2,3,4

 

Product Registration

Product registration in Malaysia is supported by an online database that requires to upload the product documentation based on the Common Submission Dossier Template (CSDT) as published by the AHWP.

 

 

Quality System

Quality system requirements rely on existing quality system certifications such as ISO 13485. No additional audits are performed for foreign manufacturers but for the Importer / distributor in Malaysia.

 

Specialties

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Singapore


General

The system for registration of medical devices in Singapore is well developed, easy to follow up and database driven.

 

Classification

Four Classes 1,2,3,4

 

Product Registration

Product registration in Singapore can be simplified to a minimum if the products are already reviewed by other authorities such as the GHTF countries. The product documen-tation is based on the Common Submission Dossier Template (CSDT).

 

Quality System

Quality system requirements rely on existing quality system certifications such as ISO 13485. No additional audits are performed for foreign manufacturers but for the Importer / distributor in Singapore.

 

Specialties

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Southkorea


General

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Classification

Four Classes 1,2,3,4

 

Product Registration

Product review is a substantial part of the approval procedure for the Korean market. It furthermore requires type tests performed by Korean accredited Laboratories based on the Korean version of international standards.

Quality System

The Korean KGMP-System is very similar to the US GMP and as such comparable to the requirements given in the ISO 13485.

 

Specialties

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India


General

India is introducing changes to the medical device regulations for some years now.
The latest legislation is called: "Medical Device Rules, 2017"

Classification

Product Registration

Quality System

Specialties

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Thailand


General

The Thai FDA published a new version of the Medical devices act (issue 2) 2019.

 

The Thai FDA, under the Thai Ministry of Public Health (MOPH), regulates medical devices in Thailand. Medical devices are categorized into one of three classes: Class I (Licensed Medical Devices, highest class), Class II (Notification Medical Devices), and Class III (General Medical Devices).

Classification

Since Thailand has aligned with the ASEAN AMDD, the medical device risk classification will adhere to guidelines on risk classifications as outlined by the AMDD.

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Content last updated 2019-10-24