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
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
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
Southkorea
General
Classification
Four Classes 1,2,3,4
Product Registration
Quality System
Specialties
India
General
Classification
Product Registration
Quality System
Specialties
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| Content last updated 2019-10-24 |